SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.

SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.

SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Diabetic Retinopathy (DR) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.

For Intravitreal Use via SUSVIMO ocular implant.

The SUSVIMO initial fill and ocular implant insertion and implant removal procedures must be performed under aseptic conditions by a physician experienced in vitreoretinal surgery. The SUSVIMO ocular implant must be surgically implanted in the eye or removed from the eye (if medically necessary) in an operating room using aseptic technique. See SUSVIMO Instructions for Use and the standardized steps to optimize surgical outcomes.

SUSVIMO refill-exchange procedures must be performed under aseptic conditions by a physician experienced in ophthalmic surgery [see Dosage and Administration (2.7)].

Do not administer SUSVIMO (ranibizumab injection) as a bolus intravitreal injection. Do not substitute SUSVIMO (ranibizumab injection) with other ranibizumab products.

Initial Fill: One SUSVIMO initial fill needle (34-gauge, with integrated 5 μm filter and blue cap) is included. A 5-micron sterile filter needle (19-gauge × 1½ inch), and a 1 mL Luer lock syringe are needed but not included.

Refill-Exchange: One SUSVIMO refill needle (34-gauge with integrated 5 μm filter and clear cap) is included. A 5-micron sterile filter needle (19-gauge × 1½ inch), and a 1 mL Luer lock syringe are needed but not included.

The recommended dose of SUSVIMO (ranibizumab injection) is 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the SUSVIMO ocular implant with refills administered every 24 weeks (approximately 6 months).

The recommended dose of SUSVIMO (ranibizumab injection) is 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the SUSVIMO ocular implant with refills administered every 36 weeks (approximately 9 months).

Supplemental treatment with 0.5 mg (0.05 mL of 10 mg/mL) intravitreal ranibizumab injection may be administered in the affected eye while the SUSVIMO implant is in place and if clinically necessary [see Clinical Studies (14)].

The implant initial fill procedure must be performed by a physician experienced in vitreoretinal surgery [see Dosage and Administration (2.1)]. The implant will be filled using aseptic technique with 0.02 mL of SUSVIMO (ranibizumab injection) prior to insertion of the implant into the patient's eye [see Dosage and Administration (2.6)].

Refer to the complete SUSVIMO Instructions for Use for the initial fill and implant procedure included in the insertion tool assembly carton for further details.

Use aseptic technique to carry out the following preparation steps prior to insertion of the ocular implant into the patient's eye:

<div class="scrollingtable"><table width="90%"> <col align="left" valign="top" width="5%"/> <col align="left" valign="top" width="45%"/> <col align="center" valign="middle" width="50%"/> <tbody class="Headless"> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 1: Gather the supplies needed.</span> <ul> <li>One SUSVIMO ocular implant with insertion tool assembly (included)</li> <li>One SUSVIMO initial fill needle (34-gauge with integrated 5 μm filter) with blue cap (included)</li> <li>One SUSVIMO (ranibizumab injection) 100 mg/mL vial (included)</li> <li>One sterile 5-micron filter needle (19-gauge × 1½ inch) <span class="Bold">(not included)</span> </li> <li>One sterile 1 mL Luer Lock syringe<span class="Bold"> (not included)</span> </li> </ul> </td><td align="center" class="Rrule"></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 2: Transfer Dose from Vial to Syringe</span></td><td align="center" class="Rrule"></td> </tr> <tr> <td align="left" class="Lrule"><span class="Bold">Note: </span></td><td align="left" class="Rrule">Use the filter needle (not included) to withdraw SUSVIMO (ranibizumab injection) from the vial. </td><td align="center" class="Botrule Rrule" rowspan="2"><span><a name="fig1"></a><img alt="Figure 1" src="/dailymed/image.cfm?name=susvimo-01.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 1</span></span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold Underline">Do not</span> use the SUSVIMO initial fill needle for this step.<ul> <li> Prepare SUSVIMO (ranibizumab injection) vial by removing the flip-off cap and disinfecting the rubber vial septum with alcohol.</li> <li>Attach a filter needle to the syringe by screwing it tightly onto the Luer lock (see <a href="#fig1">Figure 1</a>).</li> <li>Carefully remove the needle cap by pulling it straight off.</li> <li>Using aseptic technique, withdraw all of the contents of the SUSVIMO (ranibizumab injection) vial through the filter needle into the syringe.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 3: Remove Air from Syringe</span> <ul class="Disc"> <li> With the filter needle attached, hold the syringe with the needle pointing up. </li> <li> If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (Figure 2). </li> <li> Slowly push the plunger rod just until all air is expelled from the syringe and needle. <dl> <dt>–</dt> <dd> It is important to preserve as much drug as possible in order to completely fill the implant. </dd> </dl> </li> <li> Remove and properly dispose of the filter needle after air is removed from syringe. </li> </ul> </td><td align="center" class="Rrule"><img alt="Figure 2" src="/dailymed/image.cfm?name=susvimo-01a.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure2</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 4: Attach SUSVIMO Initial Fill Needle</span> <br/> <br/> <span class="Bold Underline">Do not </span>use the filter needle to fill the implant.<ul> <li>Attach the SUSVIMO initial fill needle (included) firmly onto the syringe by screwing it tightly onto the Luer lock (see <a href="#fig3">Figure 3</a>). Ensure that the initial fill needle is attached to the syringe.</li> <li>Carefully remove the needle cap by pulling straight off.</li> <li> <span class="Bold">Do not </span>wipe the needle at any time.</li> </ul> </td><td align="center" class="Rrule"><span><a name="fig3"></a><img alt="Figure 3" src="/dailymed/image.cfm?name=susvimo-02.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 3</span></span></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 5: Remove Any Remaining Air from Syringe</span> <ul class="Disc"> <li> With the initial fill needle attached, hold the syringe with the needle pointing up.<br/>If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see <a href="#fig4">Figure 4</a>). </li> <li>Slowly push the plunger rod just until all air is expelled from the syringe and needle, and a drop of drug solution is seen at the needle tip (see <a href="#fig5">Figure 5</a>).</li> </ul> </td><td align="center" class="Botrule Rrule" rowspan="2"><span><a name="fig4"></a><img alt="Figure 4" src="/dailymed/image.cfm?name=susvimo-03.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 4</span></span> <br/> <span><a name="fig5"></a><img alt="Figure 5" src="/dailymed/image.cfm?name=susvimo-04.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 5</span></span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule"><span class="Bold">Note: </span></td><td align="left" class="Rrule">It is important to preserve as much drug as possible in order to completely fill the implant. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 6: Inspect the Syringe for Air Bubbles</span> <ul> <li> Inspect the syringe and the needle hub to ensure that no air bubbles are present (see <a href="#fig6">Figure 6</a>).</li> <li>If air bubbles are present, continue to remove air from the syringe and reinspect.</li> </ul> </td><td align="center" class="Botrule Rrule" rowspan="2"><span><a name="fig6"></a><img alt="Figure 6" src="/dailymed/image.cfm?name=susvimo-05.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 6</span></span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule"><span class="Bold">Note: </span></td><td align="left" class="Rrule">Use the syringe within <span class="Bold Underline">15 minutes</span> of removing all air to avoid ranibizumab drying in the needle and impeding fluid flow.<br/> <span class="Bold">Do not </span>use the initial fill needle if the needle is clogged.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 7: Load Syringe into the Carrier</span> <br/> <span class="Bold">Do not </span>hold or push on the plunger rod of the syringe while inserting the needle into the implant septum.<ul> <li>Retrieve insertion tool carrier with pre-positioned implant from the inner tray.</li> <li>Align the syringe Luer lock above the Luer lock slot in the carrier to protect the needle from being damaged.</li> <li>Lower the syringe into the carrier (see <a href="#fig7">Figure 7</a>).</li> <li>Push the syringe forward until it stops, taking care to avoid touching the plunger rod (see <a href="#fig8">Figure 8</a>)</li> <li>With the syringe loaded, (see <a href="#fig9">Figure 9</a>) the initial fill needle should now be penetrating the implant septum.</li> </ul> </td><td align="center" class="Rrule"><span><a name="fig7"></a><img alt="Figure 7" src="/dailymed/image.cfm?name=susvimo-06.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 7:</span> Align and lower the syringe into the carrier</span> <br/> <span><a name="fig8"></a><img alt="Figure 8" src="/dailymed/image.cfm?name=susvimo-07.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 8: </span>Push the syringe into the carrier</span> <br/> <a name="fig9"></a><img alt="Figure 9" src="/dailymed/image.cfm?name=susvimo-08.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 9: </span>Syringe with initial fill needle inserted through the implant septum </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 8: Fill Ocular Implant with SUSVIMO (ranibizumab injection) Under Microscope</span> <ul> <li>Under the microscope, <span class="Bold Underline">slowly</span> administer SUSVIMO (ranibizumab injection) into the ocular implant by slightly tilting the carrier upwards (see <a href="#fig10">Figure 10</a>).</li> <li>The ocular implant should be filled over approximately <span class="Bold Underline">5 to 10 seconds</span>, to help avoid air entrapment in the implant reservoir.</li> </ul> </td><td align="center" class="Botrule Rrule" rowspan="3"><span><a name="fig10"></a><img alt="Figure 10" src="/dailymed/image.cfm?name=susvimo-09.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span> <br/> <span class="Bold">Figure 10: </span>Administer ranibizumab into the implant<br/> <span><a name="fig11"></a><img alt="Figure 11" src="/dailymed/image.cfm?name=susvimo-10.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span> <br/> <span class="Bold">Figure 11: </span>Dome of drug solution forms at tip of implant as viewed under magnification</td> </tr> <tr> <td align="left" class="Lrule"><span class="Bold">Note:</span></td><td align="left" class="Rrule">When filling the ocular implant, drug solution should only exit the ocular implant from the release control element. If drug solution is leaking from the implant at a different location, such as the side of the implant, <span class="Bold">do not</span> use the ocular implant.<br/>If fluid is leaking from the septum at the needle insertion site, the needle may not be fully penetrating the implant septum. Fully push the syringe forward before continuing to fill the ocular implant. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"> <ul> <li>Continue filling the ocular implant until the implant is completely full of drug solution and all air has been expelled as evidenced by a dome of drug solution formed at the tip of the implant on the release control element (see <a href="#fig11">Figure 11</a>).</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 9: Inspect the Filled Ocular Implant Under the Microscope</span> <ul> <li>Inspect the ocular implant under the microscope to ensure that the ocular implant is completely full of drug solution (see <a href="#fig12">Figure 12</a>).</li> </ul> </td><td align="center" class="Botrule Rrule" rowspan="3"><span><a name="fig12"></a><img alt="Figure 12" src="/dailymed/image.cfm?name=susvimo-11.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span> <br/> <span class="Bold">Figure 12: </span>Proper appearance of implant after initial filling with ranibizumab</td> </tr> <tr> <td align="left" class="Lrule"><span class="Bold">Note:</span></td><td align="left" class="Rrule">Minimize air bubbles within the implant reservoir as they may cause slower drug release. If an air bubble is present, it must be no larger than 1/3 of the widest diameter of the implant. If excess air is observed, <span class="Bold">do not</span> use the ocular implant.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule"><span class="Bold">Note:</span></td><td align="left" class="Rrule"><span class="Bold">No more than <span class="Underline">30 minutes</span> should pass between the initial fill of the implant and the insertion into the patient's eye</span> to ensure that the release control element remains saturated with SUSVIMO (ranibizumab injection). If SUSVIMO (ranibizumab injection) dries in the release control element, the implant may not release the drug properly into the vitreous after insertion.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 10: Remove the Syringe and Guide Sleeve from the Carrier</span> <ul> <li>Remove the syringe and guide sleeve from the carrier by pulling back on the syringe (see <a href="#fig13">Figure 13</a>). The syringe will be locked into the guide sleeve.</li> <li>Properly dispose of the used syringe together with the needle and guide sleeve in a sharps disposal container or in accordance with local requirements.</li> </ul> </td><td align="center" class="Rrule"><span><a name="fig13"></a><img alt="Figure 13" src="/dailymed/image.cfm?name=susvimo-12.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 13:</span> Remove the syringe and guide sleeve from the insertion tool carrier</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 11: Slide the Insertion Tool Handle into the Carrier</span> <ul> <li>Slide the insertion tool handle into the guide channel of the carrier, ensuring that both components are facing upwards (see <a href="#fig14">Figure 14</a>).</li> <li>Push the handle forward as far as it will go into the gripper tips (see <a href="#fig15">Figure 15</a>).</li> </ul> </td><td align="center" class="Botrule Rrule" rowspan="2"><span><a name="fig14"></a><img alt="Figure 14" src="/dailymed/image.cfm?name=susvimo-13.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 14:</span> Insert the handle into the insertion tool carrier</span> <br/> <a name="fig15"></a><img alt="Figure 15" src="/dailymed/image.cfm?name=susvimo-14.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 15: </span>Fully inserted handle</td> </tr> <tr class="Last"> <td align="left" class="Lrule"><span class="Bold">Note:</span></td><td align="left" class="Rrule"><span class="Bold">Do not</span> withdraw the handle and implant until the eye is ready for insertion. Contact between the implant and any surface or object – even within the sterile field – may result in the introduction of a foreign body into the vitreous.</td> </tr> </tbody> </table></div>

SUSVIMO ocular implant insertion is a surgical procedure that is performed in an operating room. The procedure must be performed under aseptic conditions by a physician experienced in vitreoretinal surgery [see Dosage and Administration (2.1)].

The ocular implant is filled with SUSVIMO (ranibizumab injection) immediately prior to insertion. No more than 30 minutes should pass between the initial fill of the ocular implant and the insertion into the patient's eye.

After placing an infusion line in the eye, create at least a 6×6 mm peritomy of the conjunctiva and Tenon's capsule centered around the selected SUSVIMO implant location in the supero-temporal quadrant. Perform careful conjunctival incision, hemostasis of the underlying sclera, and generous undermining of Tenon's capsule. Using aseptic technique, fill the ocular implant [see Dosage and Administration (2.5)]. Using an MVR blade, create a full thickness dissection of the sclera 4 mm from the limbus until the pars plana is fully visible, with final target scleral incision length of 3.5 mm. Using a 532 nm laser endoprobe, apply contiguous, overlapping laser spots starting at 300 mW 1000 ms along the full length of the exposed pars plana and repeat until complete ablation is achieved. Pass a 3.2 mm slit knife perpendicularly through the center of the scleral dissection to open the underlying pars plana. Use the insertion tool to slowly insert the SUSVIMO implant into the sclero-pars plana incision perpendicular to the globe, ensuring that the long axis of the implant flange is properly aligned with the sclero-pars plana incision. Using the closed gripper tips of the insertion tool, seat the implant flush against the sclera. Clean any residual vitreous around the implant flange using a vitrector. Suture both Tenon's capsule and conjunctiva, using scleral anchoring at the apex of the peritomy, ensuring complete coverage of the implant flange. Refer to the complete SUSVIMO Instructions for Use for the initial fill and implant procedure included in the insertion tool assembly carton for further details.

Removal of the SUSVIMO ocular implant is a surgical procedure that is performed in an operating room. The procedure must be performed under aseptic conditions by a physician experienced in vitreoretinal surgery [see Dosage and Administration (2.1)].

After placing an infusion line in the eye, create at least a 6×6 mm peritomy of the conjunctiva and Tenon's capsule around the SUSVIMO ocular implant flange. Remove any fibrous capsule or scar tissue that may have formed over the implant flange and septum using scalpel and forceps. With the explant tool oriented perpendicular to the globe, align the contoured tips with the long axis of the implant flange and grasp underneath the implant flange. Once the implant is secured in the explant tool, pull the implant from the eye in a perpendicular motion. Clear any vitreous prolapse present within or around the scleral wound using a vitrector. Completely close the scleral incision with multiple non-absorbable sutures. Close the Tenon's capsule and conjunctiva to completely cover the scleral incision. Refer to the complete Instructions for Use for the implant removal procedure included in the explant tool carton for further details.

The SUSVIMO ocular implant refill-exchange procedure must be performed under strict aseptic conditions by a physician experienced in ophthalmic surgery [see Dosage and Administration (2.1)]. This includes the use of a surgical mask, sterile gloves, and a lid speculum.

Prior to and after the refill-exchange procedure, perform a dilated slit lamp exam and/or dilated indirect ophthalmoscopy to inspect the implant in the vitreous cavity through the pupil to identify if dislodgement of the implant septum has occurred [see Figure 31 and Warnings and Precautions (5.4)]. If the septum has dislodged, any further refill-exchange procedures should not be performed because normal device functioning cannot be assured. Discontinue treatment with SUSVIMO (ranibizumab injection) following septum dislodgement and consider implant removal should the benefit of the removal procedure outweigh the risk.

<div class="scrollingtable"><table width="90%"> <col align="left" valign="top" width="5%"/> <col align="left" valign="top" width="45%"/> <col align="center" valign="top" width="50%"/> <tbody class="Headless"> <tr class="Botrule First"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 1: Gather the supplies needed.</span> <ul> <li>One SUSVIMO Refill Needle (34-gauge with a 5 µm integrated filter) with clear cap (included)</li> <li>One SUSVIMO (ranibizumab injection) 100 mg/mL vial (included)</li> <li>One sterile 1 mL Luer Lock syringe <span class="Bold">(not included)</span> </li> <li>One sterile 5-micron filter needle (19-gauge × 1½ inch) <span class="Bold">(not included)</span> </li> </ul>Additional materials required to perform the procedure but are not provided are:<ul> <li>Anesthetic ophthalmic solutions</li> <li>Ophthalmic broad-spectrum microbicide solution</li> <li>Cotton tips and gauze</li> <li>Sterile powder free gloves</li> <li>Face masks</li> <li>Lid speculum</li> <li>Magnification such as visor or loupes</li> <li>Task lighting</li> <li>Indirect ophthalmoscope and lens</li> <li>Sterile drape <span class="Italics">(optional for refill-exchange procedure)</span> </li> </ul> </td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 2: Inspect Packaging and Components</span> <ul> <li>Prior to use in the clinic, inspect the packaging of the components for damage. <span class="Bold">Do not</span> use if the sterility has been compromised or the contents have been dropped, damaged, or tampered with.</li> <li>Check the expiration date printed on the label.</li> <li>Remove the vial from the carton. <span class="Underline">Note</span>: the outside of the vial is not sterile.</li> <li> <span class="Bold Underline">Use aseptic technique</span> to open packaging and remove the <span class="Bold Underline">sterile refill needle</span> from the tray.</li> <li>Inspect components and place onto sterile field (see <a href="#fig16">Figure 16</a>).</li> </ul> </td><td align="center" class="Rrule"><span><a name="fig16"></a><img alt="Figure 16" src="/dailymed/image.cfm?name=susvimo-15.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Figure 16</span></span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 3: Inspect SUSVIMO (ranibizumab injection)</span> <ul> <li>Visually inspect the contents of the SUSVIMO (ranibizumab injection) vial for particulate matter and discoloration.</li> <li>SUSVIMO should be colorless to pale brown</li> </ul> <span class="Bold">Do not </span>use if particulate, cloudiness, or discoloration are visible.</td><td align="center" class="Rrule"></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 4: Patient Preparation</span> <ul> <li> Dilate the pupil of the eye. </li> <li> Perform slit lamp examination and/or indirect ophthalmoscopy to inspect the implant and its components in the vitreous cavity through the dilated pupil. </li> <li>Position the patient on exam chair in the supine position at approximately 20° to 30° angle for optimal visualization of the implant.</li> <li>Apply a broad-spectrum microbicide to the periocular skin, eyelid, and ocular surface prior to the refill-exchange procedure. The use of a sterile drape is up to the physician's discretion.</li> <li>Perform the procedure under topical anesthesia.</li> <li>If needed, subconjunctival anesthesia may be administered in the nasal quadrant, away from the implant.</li> </ul> </td><td align="center" class="Rrule"></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 5: Transfer Dose from Vial to Syringe</span></td><td align="center" class="Botrule Rrule" rowspan="3"><span><a name="fig17"></a><img alt="Figure 17" src="/dailymed/image.cfm?name=susvimo-16.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 17</span></span></td> </tr> <tr> <td align="left" class="Lrule"><span class="Bold">Note:</span></td><td align="left" class="Rrule">Use the filter needle to withdraw SUSVIMO (ranibizumab injection) from the vial.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Do not</span> use the SUSVIMO refill needle for this step.<ul> <li>Prepare ranibizumab vial by removing the flip-off cap and disinfecting the rubber vial septum with alcohol.</li> <li>Attach a filter needle to the syringe by screwing it tightly onto the Luer lock (see <a href="#fig17">Figure 17</a>).</li> <li>Carefully remove the needle cap by pulling it straight off.</li> <li>Using aseptic technique, withdraw all of the contents of the SUSVIMO (ranibizumab injection) vial through the filter needle into the syringe.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 6: Remove Air from Syringe</span> <ul class="Disc"> <li> With the filter needle attached, hold the syringe with the needle pointing up. </li> <li> If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (Figure 18). </li> <li> Slowly push the plunger rod just until the air is expelled from the syringe and needle. <dl> <dt>–</dt> <dd> It is important to preserve as much drug as possible in order to completely refill the implant </dd> </dl> </li> <li> Remove and properly dispose of the filter needle after air is removed from the syringe. </li> </ul> </td><td align="center" class="Botrule Rrule"><span><a name="fig18"></a><img alt="Figure 18" src="/dailymed/image.cfm?name=susvimo-16a.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 18</span></span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 7: Attach SUSVIMO Refill Needle</span> <br/> <span class="Bold">Do not</span> use the filter needle to fill the implant.<ul> <li>Attach the SUSVIMO refill needle firmly onto the syringe by screwing it tightly onto the Luer lock (see <a href="#fig19">Figure 19</a>). Ensure that the refill needle is attached to the syringe.</li> <li> Carefully remove the needle cap, pulling straight off to avoid damage to the needle cannula.</li> <li> <span class="Bold">Do not </span>wipe the needle at any time.</li> </ul> </td><td align="center" class="Rrule"><span><a name="fig19"></a><img alt="Figure 19" src="/dailymed/image.cfm?name=susvimo-17.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Figure 19</span></span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 8: Remove Any Remaining Air from Syringe and Adjust Drug Dose</span> <ul> <li> With the refill needle attached, hold the syringe with the needle pointing up. </li> <li>If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see <a href="#fig20">Figure 20</a>).</li> <li>Slowly push the plunger rod until all air is expelled from the syringe and needle and the uppermost edge of the black plunger tip is aligned with the <span class="Bold Underline">0.1 mL</span> dose mark (see <a href="#fig21">Figure 21</a>).</li> </ul> </td><td align="center" class="Rrule"><span><a name="fig20"></a><img alt="Figure 20" src="/dailymed/image.cfm?name=susvimo-18.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span> <br/> <span class="Bold">Figure 20</span><span><a name="fig21"></a><img alt="Figure 21" src="/dailymed/image.cfm?name=susvimo-19.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span> <br/> <span class="Bold">Figure 21</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 9: Inspect the Syringe for Air Bubbles</span></td><td align="center" class="Botrule Rrule" rowspan="4"><span><a name="fig22"></a><img alt="Figure 22" src="/dailymed/image.cfm?name=susvimo-20.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span> <br/> <span class="Bold">Figure 22</span></td> </tr> <tr> <td align="left" class="Lrule"><span class="Bold">Note:</span></td><td align="left" class="Rrule">Ensure no air bubbles are present in the syringe and needle hub. Air injected into the implant could result in slower drug release. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"> <ul> <li>Inspect the syringe and the needle hub using magnification to ensure that no air bubbles are present (see <a href="#fig22">Figure 22</a>). </li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule"><span class="Bold">Note:</span></td><td align="left" class="Rrule">Use the syringe within <span class="Bold Underline">15 minutes</span> of removing all air and adjusting the drug dose to avoid drug solution drying in the needle and impeding fluid flow.<br/> <span class="Bold">Do not</span> use the refill needle or syringe if the needle is clogged.</td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 10: Stabilize the globe and orient the refill needle</span></td><td align="center" class="Botrule Rrule" rowspan="3"><span><a name="fig23"></a><img alt="Figure 23" src="/dailymed/image.cfm?name=susvimo-21.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span> <br/> <span class="Bold">Figure 23</span><span><a name="fig24"></a><img alt="Figure 24" src="/dailymed/image.cfm?name=susvimo-22.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span><span class="Bold">Figure 24</span></td> </tr> <tr> <td align="left" class="Lrule"><span class="Bold">Note:</span></td><td align="left" class="Rrule">Perform the refill-exchange procedure using magnification (e.g., loupes, reading glasses, magnifiers) for visual assistance.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"> <ul> <li>After placing the lid speculum in the eye, stabilize the globe with a cotton-tipped applicator to minimize eye movement (see <a href="#fig23">Figure 23</a>).<dl> <dt>–</dt> <dd>Recommend standing on the contralateral side of the implanted eye, with the patient looking down and toward their nose to optimally expose the implant.</dd> </dl> </li> <li>Orient the refill needle perpendicular to the globe (see <a href="#fig24">Figure 24</a>).</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 11: Insert the Refill Needle</span></td><td align="center" class="Botrule Rrule" rowspan="3"><span><a name="fig25"></a><img alt="Figure 25" src="/dailymed/image.cfm?name=susvimo-23.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span> <br/> <span class="Bold">Figure 25</span> <br/> <span><a name="fig26"></a><img alt="Figure 26" src="/dailymed/image.cfm?name=susvimo-24.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span><span class="Bold">Figure 26</span></td> </tr> <tr> <td align="left" class="Lrule"><span class="Bold">Note:</span></td><td align="left" class="Rrule">Insert needle at the very center of the implant septum and perpendicular to the implant to ensure the needle inserts fully. <span class="Bold">Do not</span> maneuver if there is resistance as it will bend the needle.<br/> <span class="Bold">Do not</span> use a bent refill needle; replace if bent or if damage is suspected.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"> <ul> <li>Targeting the center of the implant septum, insert the refill needle perpendicularly through the conjunctiva and into the implant septum (see <a href="#fig25">Figure 25</a>).<dl> <dt>–</dt> <dd>If excessive resistance, withdraw the refill needle. Orient and insert again.</dd> <dt>–</dt> <dd> <span class="Bold">Do not</span> twist when encountering conjunctiva and Tenon's capsule to gain access to the septum, as damage to the overlying tissue and to the septum of the device may result.</dd> </dl> </li> <li>Continue inserting the needle until the soft stop of the refill needle makes physical contact with the conjunctiva (see <a href="#fig26">Figure 26</a>) to provide a tactile cue that optimal contact has been made.</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 12: Refill the SUSVIMO Implant</span> <ul> <li>Refill the implant <span class="Bold Underline">slowly</span>, by delivering the entire contents of the syringe into the implant, over approximately <span class="Bold Underline">5 to 10 seconds</span>, to avoid pressure build-up in the implant reservoir. The soft stop of the refill needle must remain in contact with the conjunctiva throughout the procedure.</li> <li>As ranibizumab is administered into the implant, existing solution from the implant should immediately begin to fill the refill needle fluid collection chamber (see <a href="#fig27">Figure 27</a>).</li> <li>If fluid is not observed collecting in the refill needle fluid collection reservoir, stop injecting and ensure the refill needle is inserted into the center of the implant septum at a perpendicular angle and the soft stop is in contact with the conjunctiva.</li> <li>Administer all of the syringe contents in order to achieve the target replacement ranibizumab concentration in the implant reservoir.</li> </ul> </td><td align="center" class="Rrule"><span><a name="fig27"></a><img alt="Figure 27" src="/dailymed/image.cfm?name=susvimo-25.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 27</span></span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 13: Withdraw the Syringe</span> <ul> <li>Withdraw the syringe perpendicular to the globe to avoid damaging the septum (see <a href="#fig28">Figure 28</a>).</li> <li>A cotton-tipped applicator may be used to provide counter traction to the conjunctiva during needle withdrawal.</li> </ul> </td><td align="center" class="Rrule"><span><a name="fig28"></a><img alt="Figure 28" src="/dailymed/image.cfm?name=susvimo-26.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span> <br/> <span class="Bold">Figure 28</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 14: Dispose of the Used Components</span> <ul> <li> <span class="Bold">Do not </span>recap the needle or detach it from the syringe. Dispose of the used syringe together with the refill needle in a sharps disposal container or in accordance with local requirements.</li> </ul> </td><td align="center" class="Rrule"></td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Step 15: Perform Indirect Ophthalmoscopy</span> <ul class="Disc"> <li> Perform dilated indirect ophthalmoscopy (and slit lamp exam as needed) to ensure continued proper position of the implant and its components (e.g., septum) in the vitreous cavity and to examine for complications. </li> </ul> </td><td align="center" class="Rrule"></td> </tr> </tbody> </table></div>

For patients with AMD or DME, if a planned dose (refill-exchange) of SUSVIMO (ranibizumab injection) is missed, it should be administered as soon as possible and the subsequent refill-exchange procedures should be performed 24 weeks (approximately 6 months) thereafter.

For patients with DR, if a planned dose (refill-exchange) of SUSVIMO (ranibizumab injection) is missed, it should be administered as soon as possible and the subsequent refill-exchange procedures should be performed 36 weeks (approximately 9 months) thereafter.

Table 1 describes dosage modifications for specific adverse Reactions [see Warnings and Precautions (5)]. No dosage reductions for SUSVIMO are recommended.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 1: Dosage (Refill-Exchange) Modifications for Adverse Reactions</span> </caption> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">Adverse Reactions</th><th align="center" class="Rrule">Dosage Modification</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Intraocular inflammation ≥ 1 + cells or flare</td><td align="left" class="Rrule">Withhold dose (refill-exchange)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Sight threatening events (e.g., rhegmatogenous retinal detachment, vitreous hemorrhage, unexplained vision loss, etc.)</td><td align="left" class="Rrule">Withhold dose (refill-exchange)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Local infections of either eye</td><td align="left" class="Rrule">Withhold dose (refill-exchange)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Infectious endophthalmitis</td><td align="left" class="Rrule">Withhold dose (refill-exchange)</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Severe systemic infection</td><td align="left" class="Rrule">Withhold dose (refill-exchange)</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Observed damage to the implant</td><td align="left" class="Rrule">Withhold dose (refill-exchange) and consider SUSVIMO implant removal <span class="Italics">[see <a href="#S2.8">Dosage and Administration (2.8</a>, <a href="#S2.9">2.9)</a>]</span>.</td> </tr> </tbody> </table></div>

Injection: 100 mg/mL, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial

{ "type": "p", "children": [], "text": "Injection: 100 mg/mL, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial" }

SUSVIMO (ranibizumab injection) is contraindicated in patients with ocular or periocular infections.

SUSVIMO (ranibizumab injection) is contraindicated in patients with active intraocular inflammation.

SUSVIMO (ranibizumab injection) is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in SUSVIMO (ranibizumab injection).

In the active comparator period of controlled clinical trials in AMD, the ranibizumab implant has been associated with a 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab (1.7% in the SUSVIMO arm vs 0.5% in the intravitreal arm). When including extension phases of clinical trials, 2% (11/555) of patients receiving the ranibizumab implant experienced an episode of endophthalmitis. Reports occurred between days 5 and 853, with a median of 173 days. Many, but not all, of the cases of endophthalmitis reported a preceding or concurrent conjunctival retraction or erosion event.

In the active comparator period of the controlled clinical trial in DME, 0% of patients in the SUSVIMO arm compared to 0.3% in the intravitreal arm experienced an episode of endophthalmitis. When including the extension phase of the clinical trial, 0.7% (4/556) of patients receiving the ranibizumab implant experienced an episode of endophthalmitis. Reports occurred between days 625 and 1016, with a median of 824 days.

In the period with an observational comparator arm of the clinical trial in DR, there were no patients (0/105) in the SUSVIMO arm who experienced an episode of endophthalmitis [see Clinical Studies (14.3)]. When including the extension phase of the clinical trial 0.8% (1/128) patients receiving the ranibizumab implant experienced an episode of endophthalmitis, with the event reported on day 695.

Endophthalmitis should be treated promptly in an effort to reduce the risk of vision loss and maximize recovery. The SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed until resolution of endophthalmitis [see Dosage and Administration (2.10) and Adverse Reactions (6.1)].

Patients should not have an active or suspected ocular or periocular infection or severe systemic infection at the time of any SUSVIMO implant or refill procedure. Appropriate intraoperative handling followed by secure closure of the conjunctiva and Tenon's capsule, and early detection and surgical repair of conjunctival erosions or retractions and strict/controlled aseptic technique conditions throughout refill-exchange procedures may reduce the risk of endophthalmitis [see Dosage and Administration (2.1) and Warnings and Precautions (5.5)].

Rhegmatogenous retinal detachments have occurred in clinical trials of SUSVIMO and may result in vision loss. Rhegmatogenous retinal detachments should be promptly treated with an intervention (e.g., pneumatic retinopexy, vitrectomy, or laser photocoagulation). SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed in the presence of a retinal detachment or retinal break [see Dosage and Administration (2.10)].

Careful evaluation of the retinal periphery is recommended to be performed, and any suspected areas of abnormal vitreo-retinal adhesion or retinal breaks should be treated before inserting the implant in the eye.

In clinical trials, the device has dislocated/subluxated into the vitreous cavity or has extended outside the vitreous cavity into or beyond the subconjunctival space. Device dislocation requires urgent surgical intervention. Strict adherence to the scleral incision length and appropriate targeting of the pars plana during laser ablation may reduce the risk of implant dislocation.

In clinical trials, a type of implant damage where the septum has dislodged into the implant body has been reported. Perform a dilated slit lamp exam and/or dilated indirect ophthalmoscopy to inspect the implant in the vitreous cavity through the pupil prior to and after the refill-exchange procedure to identify if septum dislodgement has occurred. Discontinue treatment with SUSVIMO (ranibizumab injection) following septum dislodgement and consider implant removal should the benefit of the removal procedure outweigh the risk [see Dosage and Administration (2.9)].

Appropriate handling and insertion of the refill needle into the septum (avoid twisting and/or rotation) is required to minimize the risk of septum dislodgement [see Dosage and Administration (2.8)].

Vitreous hemorrhages may result in temporary vision loss. Vitrectomy may be needed in the case of a non-clearing vitreous hemorrhage [see Dosage and Administration (2.10)].

In clinical trials of SUSVIMO including extension phases in patients with AMD, vitreous hemorrhages were reported in 5.2% (23/443) of patients receiving SUSVIMO.

In the clinical trial of SUSVIMO including the extension phase in patients with DME, vitreous hemorrhages were reported in 10.1% (56/556) of patients receiving SUSVIMO.

In the clinical trial of SUSVIMO including the extension phase in patients with DR, vitreous hemorrhages were reported in 9.4% (12/128) of patients receiving SUSVIMO.

The majority of these hemorrhages occurred within the first post-operative month following surgical implantation and the majority of vitreous hemorrhages resolved spontaneously.

Patients on antithrombotic medication (e.g., oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs) may be at increased risk of vitreous hemorrhage. Antithrombotic medications are recommended to be temporarily interrupted prior to the implant insertion procedure. The SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed in the event of sight-threatening vitreous hemorrhage.

The use of pars plana laser ablation and scleral cauterization should be performed to reduce the risk of vitreous hemorrhage.

A conjunctival erosion is a full thickness degradation or breakdown of the conjunctiva in the area of the implant flange. A conjunctival retraction is a recession or opening of the limbal and/or radial peritomy. Conjunctival erosions or retractions have been associated with an increased risk of endophthalmitis, especially if the implant becomes exposed. Surgical intervention (e.g., conjunctival/Tenon's capsule repair) is recommended to be performed in case of conjunctival erosion or retraction with or without exposure of the implant flange.

In clinical trials of SUSVIMO including extension phases in patients with AMD, 3.6% (16/443) of patients receiving SUSVIMO reported conjunctival erosion and 1.6% (7/443) of patients receiving SUSVIMO reported conjunctival retraction in the study eye.

In the clinical trial of SUSVIMO including the extension phase of patients with DME, 2.2% (12/556) of patients receiving SUSVIMO reported conjunctival erosion and 1.3% (7/556) of patients receiving SUSVIMO reported conjunctival retraction in the study eye.

In the clinical trial of SUSVIMO including the extension phase in patients with DR, 2.3% (3/128) of patients receiving SUSVIMO reported conjunctival erosion and 1.6% (2/128) of patients receiving SUSVIMO reported conjunctival retraction in the study eye.

Appropriate intraoperative handling of conjunctiva and Tenon's capsule to preserve tissue integrity and secure closure of peritomy while ensuring placement of sutures away from implant edge may reduce the risk of conjunctival erosion or retraction. The implant and the tissue overlying the implant flange should be monitored routinely following the implant insertion.

A conjunctival bleb is an encapsulated elevation of the conjunctiva above the implant flange, which may be secondary to subconjunctival thickening or fluid. Conjunctival blebs may require surgical management to avoid further complications, especially if the implant septum is no longer identifiable due to the conjunctival bleb.

In clinical trials of SUSVIMO including extension phases in patients with AMD, 5.9% (26/443) of patients receiving SUSVIMO reported conjunctival bleb/conjunctival filtering bleb leak in the study eye.

In the clinical trial of SUSVIMO including the extension phase in patients with DME, 9% (50/556) of patients receiving SUSVIMO reported conjunctival bleb/conjunctival filtering bleb leak in the study eye.

In the clinical trial of SUSVIMO including the extension phase in patients with DR, 3.9% (5/128) of patients receiving SUSVIMO reported conjunctival bleb/conjunctival filtering bleb leak in the study eye.

Strict adherence to the scleral incision length, appropriate intraoperative handling of conjunctiva and Tenon's capsule to preserve tissue integrity and secure closure of peritomy, and proper seating of the refill needle during refill-exchange procedures may reduce the risk of conjunctival bleb.

Visual acuity was decreased by 4 letters on average in the first postoperative month and 2 letters on average in the second postoperative month following initial implantation of SUSVIMO in patients with AMD [see Clinical Studies (14.1)].

Visual acuity was decreased by 7 letters on average in the first postoperative month and 3 to 4 letters on average in the second postoperative month following initial implantation of SUSVIMO in patients with DME and DR [see Clinical Studies (14.2 and 14.3)].

Minimize air bubbles within the implant reservoir as they may cause slower drug release. During the initial fill procedure, if an air bubble is present, it must be no larger than 1/3 of the widest diameter of the implant. If excess air is observed after initial fill, do not use the implant. During the refill-exchange procedure, if excess air is present in the syringe and needle do not use the syringe and needle. If excess air bubbles are observed after the refill-exchange procedure, consider repeating the refill-exchange procedure.

Use caution when performing ophthalmic procedures (e.g., B-scan ophthalmic ultrasound, scleral depression, or gonioscopy) that may cause deflection or movement of the implant and subsequent injury.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.

The data below (Table 2) reflect exposure of 248 patients with AMD in the Archway study through Week 40, 320 patients with DME in the Pagoda study up to Week 64, and 105 patients with DR in the Pavillion study through Week 52 following the SUSVIMO initial fill and implant insertion, refill, and implant removal (if necessary) procedures.

In clinical trials of SUSVIMO in AMD patients, the most common (≥ 10%) adverse reactions up to Week 40 were conjunctival hemorrhage (72%), conjunctival hyperemia (26%), iritis (23%), and eye pain (10%). Septum dislodgement was reported in 0.4% of the AMD patient population.

In clinical trials of SUSVIMO in DME patients, the most common (≥ 10%) adverse reactions up to Week 64 were conjunctival hemorrhage (62%), conjunctival hyperemia (15%), iritis (14%), eye pain (13%), cataract (11%), conjunctival disorder (10%), vitreous hemorrhage (10%) and cataract (10%).

In clinical trials of SUSVIMO in DR patients, the most common (≥ 10%) adverse reactions up to Week 52 were conjunctival hemorrhage (73%), conjunctival disorder (14%), iritis (12%) and conjunctival hyperemia (11%).

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 2 Adverse Reactions occurring in ≥ 4% of patients in the SUSVIMO arm </span> </caption> <col align="left" valign="top" width="20%"/> <col align="center" valign="top" width="8%"/> <col align="center" valign="top" width="15%"/> <col align="center" valign="top" width="12%"/> <col align="center" valign="top" width="25%"/> <col align="center" valign="top" width="20%"/> <thead> <tr class="Botrule First"> <th align="center" class="Lrule Rrule" rowspan="2">Adverse Reactions</th><th align="center" class="Rrule" colspan="2">AMD<br/>Week 40</th><th align="center" class="Rrule" colspan="2">DME<br/>Week 64</th><th align="center" class="Rrule">DR<br/>Week 52</th> </tr> <tr class="Last"> <th align="center" class="Rrule">SUSVIMO<br/>n = 248</th><th align="center" class="Rrule">Intravitreal ranibizumab<br/>n = 167</th><th align="center" class="Rrule">SUSVIMO<br/>n = 320</th><th align="center" class="Rrule">Intravitreal ranibizumab<br/>0.5 mg<br/>n = 314</th><th align="center" class="Rrule">SUSVIMO<br/>n = 105</th> </tr> </thead> <tfoot> <tr> <td align="left" colspan="6"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Iritis includes: iritis, anterior chamber flare, anterior chamber inflammation, and anterior chamber cell.</dd> <dt> <a href="#footnote-reference-2" name="footnote-2">†</a> </dt> <dd>Conjunctival disorder includes: conjunctival adhesion, conjunctival disorder, conjunctival edema, conjunctival erosion, conjunctival retraction, and subconjunctival fibrosis.</dd> <dt> <a href="#footnote-reference-3" name="footnote-3">‡</a> </dt> <dd>Conjunctival bleb/filtering bleb leak includes: conjunctival bleb, conjunctival filtering bleb leak, conjunctival cyst, subconjunctival cyst, and implant site cyst.</dd> <dt> <a href="#footnote-reference-4" name="footnote-4">§</a> </dt> <dd>Headache includes: headache and procedural headache.</dd> <dt> <a href="#footnote-reference-5" name="footnote-5">¶</a> </dt> <dd>Cataract includes: cataract, cortical cataract, nuclear cataract, and subcapsular cataract.</dd> <dt> <a href="#footnote-reference-6" name="footnote-6">#</a> </dt> <dd>Corneal abrasion includes: corneal abrasion and vital dye staining cornea present.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Conjunctival hemorrhage</td><td align="center" class="Rrule">72%</td><td align="center" class="Rrule">6%</td><td align="center" class="Rrule">62%</td><td align="center" class="Rrule">18%</td><td align="center" class="Rrule">73%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Conjunctival hyperemia</td><td align="center" class="Rrule">26%</td><td align="center" class="Rrule">2%</td><td align="center" class="Rrule">15%</td><td align="center" class="Rrule">0</td><td align="center" class="Rrule">11%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Iritis<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></td><td align="center" class="Rrule">23%</td><td align="center" class="Rrule">0.6%</td><td align="center" class="Rrule">14%</td><td align="center" class="Rrule">2%</td><td align="center" class="Rrule">12%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Eye pain</td><td align="center" class="Rrule">10%</td><td align="center" class="Rrule">5%</td><td align="center" class="Rrule">13%</td><td align="center" class="Rrule">6%</td><td align="center" class="Rrule">9%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Conjunctival disorder<a class="Sup" href="#footnote-2" name="footnote-reference-2">†</a></td><td align="center" class="Rrule">9%</td><td align="center" class="Rrule">0</td><td align="center" class="Rrule">10%</td><td align="center" class="Rrule">0.3%</td><td align="center" class="Rrule">14%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Vitreous floaters</td><td align="center" class="Rrule">9%</td><td align="center" class="Rrule">2%</td><td align="center" class="Rrule">4%</td><td align="center" class="Rrule">5%</td><td align="center" class="Rrule">2%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Conjunctival bleb/ filtering bleb leak<a class="Sup" href="#footnote-3" name="footnote-reference-3">‡</a></td><td align="center" class="Rrule">8%</td><td align="center" class="Rrule">0</td><td align="center" class="Rrule">8%</td><td align="center" class="Rrule">0</td><td align="center" class="Rrule">2%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Foreign body sensation in eyes</td><td align="center" class="Rrule">7%</td><td align="center" class="Rrule">1%</td><td align="center" class="Rrule">3%</td><td align="center" class="Rrule">2%</td><td align="center" class="Rrule">9%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Headache<a class="Sup" href="#footnote-4" name="footnote-reference-4">§</a></td><td align="center" class="Rrule">6%</td><td align="center" class="Rrule">2%</td><td align="center" class="Rrule">6%</td><td align="center" class="Rrule">4%</td><td align="center" class="Rrule">9%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Hypotony of eye</td><td align="center" class="Rrule">6%</td><td align="center" class="Rrule">0</td><td align="center" class="Rrule">3%</td><td align="center" class="Rrule">0</td><td align="center" class="Rrule">0</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Vitreous detachment</td><td align="center" class="Rrule">6%</td><td align="center" class="Rrule">5%</td><td align="center" class="Rrule">8%</td><td align="center" class="Rrule">5%</td><td align="center" class="Rrule">9%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Vitreous hemorrhage</td><td align="center" class="Rrule">5%</td><td align="center" class="Rrule">2%</td><td align="center" class="Rrule">10%</td><td align="center" class="Rrule">2%</td><td align="center" class="Rrule">6%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Cataract<a class="Sup" href="#footnote-5" name="footnote-reference-5">¶</a></td><td align="center" class="Rrule">4%</td><td align="center" class="Rrule">4%</td><td align="center" class="Rrule">11%</td><td align="center" class="Rrule">7%</td><td align="center" class="Rrule">7%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Corneal disorder</td><td align="center" class="Rrule">4%</td><td align="center" class="Rrule">0</td><td align="center" class="Rrule">1%</td><td align="center" class="Rrule">0</td><td align="center" class="Rrule">1%</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Corneal abrasion<a class="Sup" href="#footnote-6" name="footnote-reference-6">#</a></td><td align="center" class="Rrule">4%</td><td align="center" class="Rrule">0.6%</td><td align="center" class="Rrule">4%</td><td align="center" class="Rrule">1%</td><td align="center" class="Rrule">4%</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Corneal edema</td><td align="center" class="Rrule">4%</td><td align="center" class="Rrule">0</td><td align="center" class="Rrule">4%</td><td align="center" class="Rrule">0.3%</td><td align="center" class="Rrule">4%</td> </tr> </tbody> </table></div>

In clinical trials of SUSVIMO, hyphema was reported in 0.4% of AMD patients, 1.9% of DME patients, and 1.9% of DR patients.

Risk Summary

There are no adequate and well-controlled studies of SUSVIMO (ranibizumab injection) administration in pregnant women. Administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses up to 41 times the human exposure (based on serum levels following the recommended clinical dose). No skeletal abnormalities were observed at serum trough levels similar to the human exposure after a single eye treatment at the recommended clinical dose (see Data).

Animal reproduction studies are not always predictive of human response, and it is not known whether ranibizumab can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for ranibizumab [see Clinical Pharmacology (12.1)], treatment with SUSVIMO (ranibizumab injection) may pose a risk to human embryofetal development.

All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects is 2% – 4% and of miscarriage is 15% – 20% of clinically recognized pregnancies.

Data

Animal Data

An embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. Pregnant animals received intravitreal injections of ranibizumab every 14 days starting on Day 20 of gestation, until Day 62 at doses of 0, 0.125, and 1 mg/eye. Skeletal abnormalities including incomplete and/or irregular ossification of bones in the skull, vertebral column, and hindlimbs and shortened supernumerary ribs were seen at a low incidence in fetuses from animals treated with 1 mg/eye of ranibizumab. The 1 mg/eye dose resulted in trough serum ranibizumab levels up to 41 times higher than observed human Cmax levels of SUSVIMO (ranibizumab injection) after treatment of a single eye.

No skeletal abnormalities were seen at the lower dose of 0.125 mg/eye, a dose which resulted in trough exposures similar to single eye treatment with SUSVIMO (ranibizumab injection) in humans. No effect on the weight or structure of the placenta, maternal toxicity, or embryotoxicity was observed.

Risk Summary

There are no data available on the presence of ranibizumab in human milk, the effects of ranibizumab on the breastfed infant or the effects of ranibizumab on milk production/excretion. Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when SUSVIMO is administered to a nursing woman.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SUSVIMO (ranibizumab injection) and any potential adverse effects on the breastfed child from ranibizumab.

Contraception

Females of reproductive potential should use effective contraception during treatment with SUSVIMO (ranibizumab injection) and for at least 12 months after the last dose of SUSVIMO (ranibizumab injection).

Infertility

No studies on the effects of ranibizumab on fertility have been conducted and it is not known whether ranibizumab can affect reproduction capacity. Based on the anti-VEGF mechanism of action for ranibizumab, treatment with SUSVIMO (ranibizumab injection) may pose a risk to reproductive capacity.

The safety and efficacy of SUSVIMO (ranibizumab injection) in pediatric patients have not been established.

In the Archway study, 90% (222 of 248) of the patients randomized to treatment with SUSVIMO were ≥ 65 years old and approximately 57% (141 of 248) were ≥ 75 years old. No notable difference in treatment effect or safety was seen with increasing age.

Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor-A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product.

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SUSVIMO (ranibizumab injection) is supplied as a sterile, clear to slightly opalescent, colorless to pale brown solution for intravitreal use via the SUSVIMO implant. Each single-dose vial contains 10 mg of ranibizumab, histidine HCl (0.1 mg), polysorbate 20 (0.01 mg), sucrose (8.2 mg), and Water for Injection, in 0.1 mL of solution with a pH of 5.5. The SUSVIMO implant is designed to contain approximately 0.02 mL (2 mg) of ranibizumab solution when filled. SUSVIMO does not contain an antimicrobial preservative.

{ "type": "p", "children": [], "text": "SUSVIMO (ranibizumab injection) is supplied as a sterile, clear to slightly opalescent, colorless to pale brown solution for intravitreal use via the SUSVIMO implant. Each single-dose vial contains 10 mg of ranibizumab, histidine HCl (0.1 mg), polysorbate 20 (0.01 mg), sucrose (8.2 mg), and Water for Injection, in 0.1 mL of solution with a pH of 5.5. The SUSVIMO implant is designed to contain approximately 0.02 mL (2 mg) of ranibizumab solution when filled. SUSVIMO does not contain an antimicrobial preservative." }

Ranibizumab binds to the receptor binding site of multiple biologically active forms of VEGF-A, including VEGF110. VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and is thought to contribute to pathophysiology of neovascular AMD. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.

The SUSVIMO implant provides a continuous release of ranibizumab where the release of ranibizumab into the vitreous decreases over time as the concentration in the implant decreases. The ranibizumab serum and aqueous humor concentrations with a SUSVIMO 24-week and 36-week treatment interval are maintained below the maximum and above the minimum concentrations experienced with monthly 0.5 mg intravitreal ranibizumab.

Distribution

Ranibizumab did not accumulate in serum when administered with refills every 24 weeks or every 36 weeks.

Following implant insertion of SUSVIMO in patients with AMD, the mean (±SD) maximum ranibizumab serum concentration (Cmax) was 0.48 (±0.17) ng/mL and median (range) time to maximum serum concentration (Tmax) was 26 (1 – 89) days. Following the initial fill and refill of SUSVIMO in patients, maximum serum concentrations of ranibizumab were below the ranibizumab concentration necessary to inhibit the biological activity of VEGF by 50%.

Elimination

Metabolism

The metabolism of SUSVIMO (ranibizumab injection) has not been studied. SUSVIMO (ranibizumab injection) is a monoclonal antibody fragment and antibodies are cleared principally by catabolism.

Excretion

The full excretion profile for ranibizumab following administration of SUSVIMO is unknown.

Specific Populations

Patients with renal impairment were included in the population pharmacokinetic analysis of SUSVIMO (ranibizumab injection). Across all indications, systemic clearance of ranibizumab was slightly lower in renally impaired patients but was not clinically significant. No clinically significant differences in the pharmacokinetics of ranibizumab were observed based on age in the patient population.

As with all therapeutic proteins, there is potential for immune response in patients treated with ranibizumab including SUSVIMO. The detection of an immune response is highly dependent on the sensitivity, specificity, and drug tolerance level of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the study described below with the incidence of antibodies in other studies or to other products may be misleading.

Prior to treatment with SUSVIMO, 2.1-3.6% of patients with AMD, DME, or DR tested positive for anti-ranibizumab antibodies. In patients with AMD, after the SUSVIMO implant insertion and treatment, 12% (29 of 247) patients tested positive for anti-ranibizumab antibodies. In patients with DME, after 4 doses of intravitreal ranibizumab, and SUSVIMO implant insertion and treatment, 13% (41 of 320) patients tested positive for anti-ranibizumab antibodies. In patients with DR, after 2 doses of intravitreal ranibizumab, and SUSVIMO implant insertion and treatment, 17% (17 of 99) patients tested positive for anti-ranibizumab antibodies. No clinically meaningful differences in the pharmacokinetics, efficacy, or safety in patients testing positive for anti-ranibizumab antibodies were observed.

No studies have been conducted to determine the carcinogenic or mutagenic potential of SUSVIMO (ranibizumab injection). Based on the anti-VEGF mechanism of action for ranibizumab, treatment with SUSVIMO (ranibizumab injection) may pose a risk to reproductive capacity [see Females and Males of Reproductive Potential (8.3)].

The clinical efficacy and safety of SUSVIMO (ranibizumab injection) was assessed in a randomized, visual assessor-masked, active treatment-controlled study (Archway-NCT03677934) in patients with AMD. A total of 415 patients (248 in the SUSVIMO arm and 167 in the intravitreal ranibizumab arm) were enrolled and treated in this study. Patients were diagnosed with AMD within the 9 months prior to screening and received ≥ 3 doses of anti-VEGF intravitreal agents in the study eye within the last 6 months prior to screening. Each patient was required to have demonstrated a response to an anti-VEGF intravitreal agent prior to randomization. Patients were randomized in a 3:2 ratio to receive continuous delivery of SUSVIMO (ranibizumab injection) via the SUSVIMO implant every 24 weeks or 0.5 mg intravitreal ranibizumab injections every 4 weeks. For patients randomized to the SUSVIMO arm, supplemental treatment with 0.5 mg intravitreal ranibizumab injections was available at Weeks 16, 20, 40, 44, 64, 68, 88, and 92, if needed. In the first 24 weeks, 1.6% of patients assessed for supplemental treatment received 1 or more supplemental treatment(s) and in the following 24 weeks, 5.4% of patients assessed for supplemental treatment received 1 or more supplemental treatment(s).

The primary efficacy endpoint of change from baseline in distance Best Corrected Visual Acuity (BCVA) score averaged over Week 36 and Week 40 demonstrated that SUSVIMO was equivalent to intravitreal ranibizumab injections administered every 4 weeks. Detailed efficacy results are shown in Table 3 and Figure 29 below.

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 3 Visual Acuity outcomes at Week 40 in Archway (GR40548) Study</span> </caption> <col align="left" valign="top" width="40%"/> <col align="center" valign="top" width="20%"/> <col align="center" valign="top" width="20%"/> <col align="center" valign="top" width="20%"/> <thead> <tr class="First Last"> <th align="center" class="Lrule Rrule">Outcome Measure<a class="Sup" href="#footnote-7" name="footnote-reference-7">*</a></th><th align="center" class="Rrule">SUSVIMO (100 mg/mL)<br/>n=248</th><th align="center" class="Rrule">Intravitreal ranibizumab 0.5 mg (10 mg/mL)<br/>n=167</th><th align="center" class="Rrule">Difference<br/>(95% CI)<a class="Sup" href="#footnote-8" name="footnote-reference-8">†</a></th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="4" valign="top">BCVA = Best corrected visual acuity</td> </tr> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-7" name="footnote-7">*</a> </dt> <dd>BCVA measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart at a starting distance of 4 meters.</dd> <dt> <a href="#footnote-reference-8" name="footnote-8">†</a> </dt> <dd>All estimates are adjusted estimates based on a mixed-effect model with repeated measures. SUSVIMO arm - intravitreal ranibizumab arm. 95% is a rounding of 95.03% CI; The type 1 error was adjusted for interim safety monitoring.</dd> <dt> <a href="#footnote-reference-9" name="footnote-9">‡</a> </dt> <dd>Equivalence margins were ±4.5 letters. </dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="First Last"> <td align="left" class="Lrule Rrule">Adjusted Mean change from baseline in BCVA score averaged over Weeks 36 and 40</td><td align="center" class="Rrule">0.2</td><td align="center" class="Rrule">0.5</td><td align="center" class="Rrule">-0.3<br/>(-1.7, 1.1)<a class="Sup" href="#footnote-9" name="footnote-reference-9">‡</a></td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table class="Noautorules" width="75%"> <col align="left" valign="top" width="100%"/> <tfoot> <tr> <td align="left" valign="top">Q24W = every 24 weeks; Q4W = every 4 weeks</td> </tr> <tr> <td align="left" colspan="1"> <dl class="Footnote"> <dt> <a href="#footnote-reference-10" name="footnote-10">*</a> </dt> <dd>Prior to study treatment, a median of 4 doses of anti-VEGF intravitreal agents were administered in the study eye of patients in the SUSVIMO and intravitreal ranibizumab arms.</dd> <dt> <a href="#footnote-reference-11" name="footnote-11">†</a> </dt> <dd>Decrease in BCVA at Week 4 during post-operative recovery period.</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left"><span class="Bold"><a name="fig29"></a>Figure 29 Adjusted Mean change from Baseline in Best Corrected Visual Acuity in study eye through Week 48 in the Archway (GR40548) study<a class="Sup" href="#footnote-10" name="footnote-reference-10">*</a>, <a class="Sup" href="#footnote-11" name="footnote-reference-11">†</a></span></td> </tr> <tr> <td align="left"> <p class="First"> <img alt="Figure 29" src="/dailymed/image.cfm?name=susvimo-27.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></p> </td> </tr> </tbody> </table></div>

Consistent results were observed across patient subgroup analyses for mean change from baseline in BCVA score (age, gender, number of prior anti-VEGF intravitreal injections, and baseline BCVA score).

The clinical efficacy and safety of SUSVIMO were assessed in a randomized, visual assessor-masked, active treatment-controlled study [Pagoda (GR40550) NCT04108156] in patients with DME. A total of 634 patients (381 in the SUSVIMO arm and 253 in the intravitreal ranibizumab 0.5 mg arm) were enrolled and treated in this study. Patients were randomized in a 3:2 ratio to receive continuous delivery of SUSVIMO via the implant every 24 weeks or 0.5 mg intravitreal ranibizumab injections every 4 weeks.

Prior to study treatment, a median of 4 doses of intravitreal ranibizumab 0.5 mg were administered in the study eye of patients in the SUSVIMO and intravitreal ranibizumab arms. Patient ages ranged from 29 to 89 years with a mean of 60.7 years. A total of 21% of patients were previously treated for DME. At baseline, the overall mean visual acuity was 65.3 letters (range: 25 to 89 letters).

The primary efficacy endpoint of change from baseline in distance Best Corrected Visual Acuity (BCVA) score averaged over Week 60 and Week 64 demonstrated that SUSVIMO was non-inferior to intravitreal ranibizumab injections administered every 4 weeks. Detailed efficacy results are shown in Table 4 and Figure 30 below.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 4 Key efficacy outcomes at Week 60 and Week 64 in the Pagoda (GR40550) Study</span> </caption> <col align="left" valign="top" width="30%"/> <col align="center" valign="top" width="20%"/> <col align="center" valign="top" width="25%"/> <col align="center" valign="top" width="25%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Outcome Measure<a class="Sup" href="#footnote-13">†</a></th><th align="center" class="Rrule">SUSVIMO 100 mg/mL<br/>n=381</th><th align="center" class="Rrule">Intravitreal ranibizumab 0.5 mg<br/> (10 mg/mL)<br/>n=253</th><th align="center" class="Rrule">Difference<br/>(95% CI)<a class="Sup" href="#footnote-12" name="footnote-reference-12">*</a></th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="4" valign="top">BCVA = Best corrected visual acuity</td> </tr> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-12" name="footnote-12">*</a> </dt> <dd>All estimates are adjusted estimates based on a mixed-effect model with repeated measures. 95% is a rounding of 95.05% CI; The type 1 error was adjusted for interim safety monitoring.</dd> <dt> <a href="#footnote-reference-13" name="footnote-13">†</a> </dt> <dd>BCVA measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart at a starting distance of 4 meters.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="First Last"> <td align="left" class="Lrule Rrule">Change in BCVA<a class="Sup" href="#footnote-13" name="footnote-reference-13">†</a> scores from baseline averaged over Week 60 and Week 64<br/>Adjusted Mean</td><td align="center" class="Rrule">9.6</td><td align="center" class="Rrule">9.4</td><td align="center" class="Rrule">0.2 (-1.2, 1.6)</td> </tr> </tbody> </table></div>

Figure 30 Adjusted Mean change from Baseline in Best Corrected Visual Acuity in study eye through Week 64 in the Pagoda (GR40550) study

Consistent results were observed across patient subgroup analyses for mean change from baseline in BCVA score (age, ethnicity, gender, baseline HbA1c score, focal/macular laser history, baseline BCVA score, prior intravitreal anti-VEGF treatment and DR severity).

The clinical efficacy and safety of SUSVIMO were assessed in a randomized, visual assessor and reading center-masked study [Pavilion (GR 41675)- NCT04503551] in patients with moderately-severe to severe non-proliferative diabetic retinopathy (NPDR) [Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS-DRSS) of 47 or 53], without center-involved DME (CI-DME), and who had not received prior treatment in the study eye for DR. A total of 174 patients (106 in the SUSVIMO arm and 68 in the observational comparator arm) were enrolled in this study.

Patients who had not received prior treatment in the study eye for DR were randomized in a 5:3 ratio to continuous delivery of SUSVIMO via the implant every 36 weeks or to clinical observation. Prior to the implant procedure, two loading doses of intravitreal ranibizumab 0.5 mg were administered in the study eye. The observational comparator arm did not receive loading doses of intravitreal ranibizumab. For patients who developed CI-DME or proliferative diabetic retinopathy/anterior segment neovascularization in either arm, supplemental treatment with intravitreal injections of 0.5 mg ranibizumab was available per investigator's clinical judgment at any non-refill-exchange study visit.

Patient ages ranged from 24 to 83 years with a mean of 53.9 years. At baseline, the overall mean visual acuity was 82.4 letters (range: 69 to 97 letters).

The primary efficacy endpoint was the proportion of patients with a ≥ 2-step improvement on the ETDRS-DRSS from baseline at Week 52 versus clinical observation. SUSVIMO with two loading doses of intravitreal ranibizumab was superior to clinical observation at Week 52. Detailed results are shown in Table 5 and Figure 31 below.

<div class="scrollingtable"><table width="85%"> <caption> <span>Table 5 Efficacy Outcomes through Week 52 in the Pavilion (GR41675) Study</span> </caption> <col align="left" valign="top" width="25%"/> <col align="center" valign="top" width="25%"/> <col align="center" valign="top" width="25%"/> <col align="center" valign="top" width="25%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Outcome Measure</th><th align="center" class="Rrule">SUSVIMO<br/>100 mg/mL<br/>(n=106)</th><th align="center" class="Rrule">Clinical Observation<br/>(n=68)</th><th align="center" class="Rrule">Difference<br/>95% CI <a class="Sup" href="#footnote-14" name="footnote-reference-14">*</a></th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="4" valign="top">ETDRS-DRSS = Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scores<br/>CMH = Cochran-Mantel-Haenszel test</td> </tr> <tr> <td align="left" colspan="4"> <dl class="Footnote"> <dt> <a href="#footnote-reference-14" name="footnote-14">*</a> </dt> <dd>All estimates are adjusted estimates based on the CMH method. 95% is a rounding of 95.04% CI; the type 1 error was adjusted for interim safety monitoring. p&lt;0.01 compared with clinical observation.</dd> </dl> </td> </tr> </tfoot> <tbody> <tr class="First Last"> <td align="left" class="Lrule Rrule">Adjusted proportion of patients with ≥ 2-step improvement from baseline on the ETDRS-DRSS at Week 52</td><td align="center" class="Rrule">80%</td><td align="center" class="Rrule">9%</td><td align="center" class="Rrule">71% (61%, 81%)</td> </tr> </tbody> </table></div>

Figure 31 Adjusted Proportion of Patients with a ≥ 2-Step Improvement from Baseline on ETDRS-DRSS in Study Eye over Time through Week 52 in the Pavilion (GR41675) Study

In the SUSVIMO arm, none of the patients assessed for supplemental treatment received any supplemental injections of intravitreal ranibizumab and 40% of patients in the observational comparator arm received 1 or more supplemental treatments through Week 52.

Consistent results were observed across patient subgroup analyses for ETDRS-DRSS score including age, race, ethnicity, baseline hemoglobin (HbA1c) and baseline ETDRS-DRSS score.

Each SUSVIMO initial fill needle kit (NDC 50242-078-55) contains:

Each SUSVIMO (ranibizumab injection) carton (NDC 50242-078-12) contains one SUSVIMO (ranibizumab injection) 100 mg/mL that is clear to slightly opalescent, colorless to slightly brownish solution in a single-dose glass vial.

Each SUSVIMO refill needle carton contains a SUSVIMO refill needle (34-gauge vented needle with a 5 μm integrated filter) with a clear cap.

<div class="scrollingtable"><table class="Noautorules" width="90%"> <col align="left" valign="top" width="50%"/> <col align="center" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Toprule" colspan="2"><span class="Bold">Device and Materials Description</span></td> </tr> <tr> <td align="center" colspan="2"><span class="Bold">Components</span></td> </tr> <tr> <td align="center" colspan="2"><img alt="Figure 32" src="/dailymed/image.cfm?name=susvimo-28b.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 32</span></td> </tr> <tr> <td align="left"><span class="Bold">SUSVIMO implant</span> <ul> <li>SUSVIMO implant (<a href="#fig33">Figure 33</a>) is capable of holding 0.02 mL of drug, and is secured within the sclera, by the extrascleral flange that remains visible through the conjunctiva following insertion.</li> <li>The septum is a self-sealing interface through which ranibizumab is administered to fill the implant.</li> </ul> </td><td align="center"><span><a name="fig33"></a><img alt="Figure 33" src="/dailymed/image.cfm?name=susvimo-29.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span> <br/> <span class="Bold">Figure 33</span></td> </tr> <tr> <td align="left"><span class="Bold">SUSVIMO (ranibizumab injection) 100 mg/mL vial</span> <ul> <li>SUSVIMO (ranibizumab injection) (<a href="#fig34">Figure 34</a>) is used to fill the implant with ranibizumab prior to insertion or during subsequent refill-exchange in an office-based setting.</li> </ul> </td><td align="center"><span><a name="fig34"></a><img alt="Figure 34" src="/dailymed/image.cfm?name=susvimo-30.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span> <br/> <span class="Bold">Figure 34</span></td> </tr> <tr> <td align="left"><span class="Bold">SUSVIMO refill needle</span> <ul> <li>SUSVIMO refill needle (<a href="#fig35">Figure 35</a>) consists of a 34 G vented needle assembly, silicone soft stop, and a 5 μm integrated filter within the needle hub. It is designed to simultaneously exchange the contents of the implant reservoir with replacement ranibizumab in an office-based setting. As replacement ranibizumab is administered into the implant through the stainless-steel cannula, fluid remaining in the implant flows through openings in the vented needle and is collected in the fluid collection reservoir.</li> <li>SUSVIMO refill needle is distinguished by its clear cap.</li> </ul> </td><td align="center"><span><a name="fig35"></a><img alt="Figure 35" src="/dailymed/image.cfm?name=susvimo-31.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></span> <br/> <span class="Bold">Figure 35</span></td> </tr> </tbody> </table></div>

Materials List

Materials that are required and supplied to perform the procedure are:

Additional materials required to perform the procedure but are not provided are:

Store SUSVIMO initial fill needle kit at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake. The SUSVIMO initial fill needle has been sterilized with electron beam processing.

Store SUSVIMO (ranibizumab injection) 100 mg/ mL vial at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake. Prior to use, the unopened vial may be kept at 9°C to 30°C (48°F to 86°F) for up to 24 hours provided it is protected from light.

Store the SUSVIMO implant and insertion tool assembly, refill needle and explant tool at room temperature 15°C to 25°C (59°F to 77°F). The SUSVIMO implant and insertion tool assembly has been sterilized with ethylene oxide gas. The SUSVIMO refill needle and explant tool have been sterilized with electron beam processing.

SUSVIMO components are supplied sterile and are for single-use only. Do not reprocess, re-sterilize, or reuse SUSVIMO components. Do not use if the sterility has been compromised or the contents have been dropped, damaged or tampered with. Do not use past the expiration date printed on the label. Do not open sealed tray until time of use. Avoid contact between sharp surgical instruments and the SUSVIMO implant as the material of the septum and silicone encasing is soft and susceptible to damage.

Important Device Handling Information

Ocular Implant Initial Fill Procedure

Ocular Implant Insertion Procedure

Ocular Implant Removal Procedure

Advise patients on the following after the implant insertion procedure:

Positioning:

How to care for the treated eye after the procedure:

Magnetic Resonance (MR) Conditional information:

Advise patients on the following after the Refill-Exchange procedure:

Advise patients on the following after the implant removal procedure (if it is deemed medically necessary):

Advise patients on the following throughout SUSVIMO treatment:

SUSVIMO® [ranibizumab injection]Manufactured by: Genentech, Inc. A Member of the Roche Group1 DNA WaySouth San Francisco, CA 94080-4990U.S. License No.: 1048

{ "type": "p", "children": [], "text": "SUSVIMO® [ranibizumab injection]Manufactured by:\nGenentech, Inc.\nA Member of the Roche Group1 DNA WaySouth San Francisco, CA 94080-4990U.S. License No.: 1048" }

SUSVIMO is a registered trademark of Genentech, Inc. ©2025 Genentech, Inc.

{ "type": "p", "children": [], "text": "SUSVIMO is a registered trademark of Genentech, Inc. ©2025 Genentech, Inc." }

<div class="scrollingtable"><table width="100%"> <col align="left" valign="top" width="52%"/> <col align="left" valign="top" width="48"/> <tfoot> <tr class="First Last"> <td align="left" valign="top">This Medication Guide has been approved by the U.S. Food and Drug Administration</td><td align="right" valign="top">Revised: 5/2025</td> </tr> </tfoot> <tbody class="Headless"> <tr class="Botrule First"> <td align="center" class="Lrule Rrule" colspan="2"><span class="Bold">MEDICATION GUIDE</span> <br/> <span class="Bold">SUSVIMO</span><span class="Sup">®</span> (suss-VIH-moh)<br/>(ranibizumab injection)<br/>for intravitreal use via SUSVIMO ocular implant</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold"><a name="whatis"></a>What is the most important information I should know about SUSVIMO?<br/>SUSVIMO (ranibizumab injection) is delivered into the eye using the SUSVIMO implant. The SUSVIMO implant and the procedures to insert, fill, refill and remove the eye (ocular) implant can cause serious side effects including:</span> <ul> <li> <span class="Bold">an eye infection (endophthalmitis).</span> Endophthalmitis is an infection of the eyeball that can cause permanent damage to your eye including blindness. <span class="Bold">Call your healthcare provider right away if you have increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye.</span> Endophthalmitis requires urgent (same day) medical or surgical treatment.</li> <li> <span class="Bold">a missing layer on top of the white part of the eye (conjunctival erosion).</span> Conjunctival erosion is an area that becomes missing (defect) in the layer (conjunctiva) that covers the white part of the eye which may result in exposure of the implant. <span class="Bold">Call your healthcare provider right away if you have a sudden feeling that something is in your eye, if you have eye discharge, or watering of the eye.</span> Conjunctival erosion may require surgical treatment.</li> <li> <span class="Bold">an opening of the layer that covers the white part of the eye (conjunctival retraction).</span> Conjunctival retraction is an opening or gaping in the layer (conjunctiva) that covers the white part of the eye which may cause the implant to be exposed. <span class="Bold">Call your healthcare provider right away if you have a sudden feeling that something is in your eye, if you have eye discharge, or watering of the eye.</span> Conjunctival retraction may require surgical treatment.</li> </ul>See <span class="Bold">"<a href="#sideeffects">What are the possible side effects of SUSVIMO?</a>"</span> for other serious side effects that may happen while in treatment with SUSVIMO.<br/> <span class="Bold">To help prevent or keep these side effects from becoming more serious follow all post-procedure instructions your healthcare provider gives you. </span>See <span class="Bold">"<a href="#receive">How will I receive SUSVIMO?</a>".</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What is SUSVIMO?</span> <br/>SUSVIMO (ranibizumab injection) is a prescription medicine used to treat adults with: <ul class="Disc"> <li>Neovascular (wet) Age-related Macular Degeneration (AMD) who have responded to at least two injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor in the gel-like part of the eye (intravitreal).</li> <li>Diabetic Macular Edema (DME) who have responded to at least two injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor in the gel-like part of the eye (intravitreal).</li> <li>Diabetic Retinopathy (DR) who have responded to at least two injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor in the gel-like part of the eye (intravitreal).</li> </ul> It is not known if SUSVIMO is safe and effective in children. </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Do not receive SUSVIMO if you:</span> <ul> <li>have an infection in or around your eye.</li> <li>have active swelling around your eye that may include pain and redness.</li> <li>are allergic to ranibizumab or any of the ingredients in SUSVIMO. See the end of this Medication Guide for a complete list of ingredients in SUSVIMO.</li> </ul>Talk to your healthcare provider before receiving this SUSVIMO if you have any of these conditions.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">Before receiving SUSVIMO, tell your healthcare provider about all of your medical conditions, including if you:</span> <ul> <li>are currently taking or have recently taken medicines that lower the chance of blood clots forming in the body such as warfarin, low or regular doses of aspirin, or nonsteroidal anti-inflammatory drugs (NSAID).</li> <li>are pregnant or plan to become pregnant. It is not known if SUSVIMO will harm your unborn baby. You should use birth control during your treatment with SUSVIMO and for 12 months after your last dose of SUSVIMO. </li> <li>are breastfeeding or plan to breastfeed. It is not known if SUSVIMO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive SUSVIMO.</li> </ul> <span class="Bold">Tell your healthcare provider about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold"><a name="receive"></a>How will I receive SUSVIMO?</span> <ul> <li>SUSVIMO is implanted through the white part of the eye (sclera) by your healthcare provider. </li> <li>Your healthcare provider will refill your implant device every 6 months (about every 24 weeks) if you have AMD or DME or every 9 months (about every 36 weeks) if you have DR.</li> <li>If you miss a scheduled refill, call your healthcare provider as soon as possible to reschedule your refill. Your next refill should be given 6 months after your last refill if you have AMD or DME, or 9 months after your last refill if you have DR.</li> </ul>Your healthcare provider will give you instructions to follow after the implant insertion, the refill procedure, and the implant removal. The instructions may include:<br/> <span class="Bold">After the Implant Insertion:</span> <ul> <li> <span class="Bold">Positioning of your head</span> <ul class="Circle"> <li>Keep your head above shoulder level for the rest of the day.</li> <li>Sleep with your head on 3 or more pillows during the day and night after your implant insertion.</li> </ul> </li> <li> <span class="Bold">How to care for your eye</span> <ul class="Circle"> <li> <span class="Bold">Do not</span> remove the eye shield from your eye until you are told to by your healthcare provider. At bedtime, continue to wear an eye shield for <span class="Bold">at least 7 nights</span> following the implant insertion.</li> <li>Take all post-operative eye medicines as your healthcare provider tells you to.</li> <li> <span class="Bold">Do not</span> push on the eye, rub the eye, or touch the area of the eye where the implant is located (underneath the eyelid in the upper and outer part of your eye) for <span class="Bold">30 days</span> following the implant insertion.</li> <li> <span class="Bold">Do not</span> participate in strenuous activities until 1 month after the implant insertion or after talking to your healthcare provider.</li> </ul> </li> <li> <span class="Bold">Magnetic Resonance Imaging (MRI) Implant Card</span> <ul class="Circle"> <li>Get your implant card from your healthcare provider after receiving the implant and keep the card in a safe place for future reference. The implant card contains important information about your SUSVIMO implant.</li> <li>Show your current and future healthcare providers your implant card. This is important if you need to have an MRI. You may only receive an MRI under very specific conditions if you have the SUSVIMO implant. Your healthcare provider will review the information on the implant card and will let you know if you should receive an MRI. </li> </ul> </li> </ul> <span class="Bold">After the Refill Procedure:</span> <ul class="Circle"> <li> <span class="Bold">Do not</span> push on the eye, rub the eye, or touch the area of the eye where the implant is located (underneath the eyelid in the upper and outer part of your eye) for <span class="Bold">7 days</span> following the refill procedure.</li> <li>Take eye drops exactly as your healthcare provider tells you to take them.</li> </ul> <span class="Bold">After the Implant Removal: </span> <ul class="Circle"> <li>Keep your head above shoulder level for the rest of the day.</li> <li>Sleep with your head on 3 or more pillows if lying down during the day and night after implant removal.</li> <li>Wear an eye shield for <span class="Bold">at least 7 nights</span> following the implant removal.</li> <li>Do not participate in strenuous activities until <span class="Bold">14 days</span> following the implant removal.</li> <li>Give all post-operative drops, as told by your healthcare provider.</li> </ul>These are not all the instructions you may receive from your healthcare provider. Following all post-procedure instructions may help prevent serious side effects or keep side effects from becoming more serious. See <span class="Bold">"<a href="#whatis">What is the most important information I should know about SUSVIMO?</a>"</span>.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What should I avoid while receiving SUSVIMO?</span> <ul> <li> <span class="Bold">Do not</span> drive or use machinery until the eye shield can be removed and you can see.</li> <li> <span class="Bold">Avoid</span> rubbing your eye or touching the area of your eye where the implant is located as much as possible while the implant is in place. If you have to rub or touch your eye, wash your hands first.</li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold"><a name="sideeffects"></a>What are the possible side effects of SUSVIMO?</span> <br/>See <span class="Bold">"<a href="#whatis">What is the most important information I should know about SUSVIMO?</a>"</span> on the first page.<br/> <span class="Bold">In addition to those side effects listed on page one, the SUSVIMO implant and the procedures to insert, fill, refill and remove the eye (ocular) implant can cause other serious side effects including:</span> <ul> <li> <span class="Bold">Tear and separation of layers of the retina (Rhegmatogenous retinal detachment).</span> Rhegmatogenous retinal detachment is a tear and separation of one of the layers of the retina in the back of the eye that senses light. Call your healthcare provider or go to the emergency room right away if you see flashing lights, see a curtain or veil covering part of your vision, have a change in your vision, or a loss of vision. Rhegmatogenous retinal detachment requires surgical treatment.</li> <li> <span class="Bold">Implant movement (Implant dislocation):</span> Tell your healthcare provider right away if you notice that the implant has moved out of place. This movement may require surgical treatment to correct.</li> <li> <span class="Bold">Implant damage</span>: Damage to the implant that prevents continued treatment (refills) with SUSVIMO. If the implant is not able to be properly refilled, your wet AMD may be inadequately treated and your physician may remove the implant and/or change your treatment.</li> <li> <span class="Bold">Bleeding (Vitreous hemorrhage):</span> Vitreous hemorrhage is bleeding within the gel-like substance (vitreous) inside of your eye. Call your healthcare provider right away if you have an increase in moving spots or what looks like spider webs in your vision as you may need an additional eye surgery.</li> <li> <span class="Bold">Bump on top of the white layer of the eye (Conjunctival bleb):</span> Conjunctival bleb is a small bulge in the layer (conjunctiva) that covers the white part of the eye where the implant is inserted. This may be due to leakage of fluid from the inside of the eye. Call your healthcare provider right away if you have a sudden feeling that something is in your eye (foreign body sensation), see a bulge over the white part of your eye, if you have eye discharge, or watering in the eye. You may need medical or surgical treatment.</li> <li> <span class="Bold">Temporary decrease in vision after the SUSVIMO procedure.</span> </li> </ul>The most common side effects of SUSVIMO include:</td> </tr> <tr> <td align="left" class="Lrule"> <ul> <li>blood on the white of the eye</li> <li>eye pain</li> </ul> </td><td align="left" class="Rrule"> <ul> <li>redness in the white of the eye</li> <li>sensitivity to light</li> </ul> </td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2">These are not all the possible side effects of SUSVIMO. <br/> <span class="Bold">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</span> <br/>You may also report side effects to Genentech at 1-888-835-2555.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">General information about the safe and effective use of SUSVIMO.</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about SUSVIMO that is written for health professionals.</td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule Rrule" colspan="2"><span class="Bold">What are the ingredients in SUSVIMO (ranibizumab injection)?</span> <br/> <span class="Bold">Active ingredient:</span> ranibizumab<br/> <span class="Bold">Inactive ingredients:</span> histidine HCl, polysorbate 20, sucrose.<br/>Manufactured by: <span class="Bold">Genentech, Inc.</span>, A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990<br/>U.S. License No.: 1048 </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"52%\"/>\n<col align=\"left\" valign=\"top\" width=\"48\"/>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" valign=\"top\">This Medication Guide has been approved by the U.S. Food and Drug Administration</td><td align=\"right\" valign=\"top\">Revised: 5/2025</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">MEDICATION GUIDE</span>\n<br/>\n<span class=\"Bold\">SUSVIMO</span><span class=\"Sup\">®</span> (suss-VIH-moh)<br/>(ranibizumab injection)<br/>for intravitreal use via SUSVIMO ocular implant</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\"><a name=\"whatis\"></a>What is the most important information I should know about SUSVIMO?<br/>SUSVIMO (ranibizumab injection) is delivered into the eye using the SUSVIMO implant. The SUSVIMO implant and the procedures to insert, fill, refill and remove the eye (ocular) implant can cause serious side effects including:</span>\n<ul>\n<li>\n<span class=\"Bold\">an eye infection (endophthalmitis).</span> Endophthalmitis is an infection of the eyeball that can cause permanent damage to your eye including blindness. <span class=\"Bold\">Call your healthcare provider right away if you have increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye.</span> Endophthalmitis requires urgent (same day) medical or surgical treatment.</li>\n<li>\n<span class=\"Bold\">a missing layer on top of the white part of the eye (conjunctival erosion).</span> Conjunctival erosion is an area that becomes missing (defect) in the layer (conjunctiva) that covers the white part of the eye which may result in exposure of the implant. <span class=\"Bold\">Call your healthcare provider right away if you have a sudden feeling that something is in your eye, if you have eye discharge, or watering of the eye.</span> Conjunctival erosion may require surgical treatment.</li>\n<li>\n<span class=\"Bold\">an opening of the layer that covers the white part of the eye (conjunctival retraction).</span> Conjunctival retraction is an opening or gaping in the layer (conjunctiva) that covers the white part of the eye which may cause the implant to be exposed. <span class=\"Bold\">Call your healthcare provider right away if you have a sudden feeling that something is in your eye, if you have eye discharge, or watering of the eye.</span> Conjunctival retraction may require surgical treatment.</li>\n</ul>See <span class=\"Bold\">\"<a href=\"#sideeffects\">What are the possible side effects of SUSVIMO?</a>\"</span> for other serious side effects that may happen while in treatment with SUSVIMO.<br/>\n<span class=\"Bold\">To help prevent or keep these side effects from becoming more serious follow all post-procedure instructions your healthcare provider gives you. </span>See <span class=\"Bold\">\"<a href=\"#receive\">How will I receive SUSVIMO?</a>\".</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What is SUSVIMO?</span>\n<br/>SUSVIMO (ranibizumab injection) is a prescription medicine used to treat adults with: <ul class=\"Disc\">\n<li>Neovascular (wet) Age-related Macular Degeneration (AMD) who have responded to at least two injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor in the gel-like part of the eye (intravitreal).</li>\n<li>Diabetic Macular Edema (DME) who have responded to at least two injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor in the gel-like part of the eye (intravitreal).</li>\n<li>Diabetic Retinopathy (DR) who have responded to at least two injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor in the gel-like part of the eye (intravitreal).</li>\n</ul>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tIt is not known if SUSVIMO is safe and effective in children. \t\t\t\t\t\t\t\t\t</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Do not receive SUSVIMO if you:</span>\n<ul>\n<li>have an infection in or around your eye.</li>\n<li>have active swelling around your eye that may include pain and redness.</li>\n<li>are allergic to ranibizumab or any of the ingredients in SUSVIMO. See the end of this Medication Guide for a complete list of ingredients in SUSVIMO.</li>\n</ul>Talk to your healthcare provider before receiving this SUSVIMO if you have any of these conditions.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">Before receiving SUSVIMO, tell your healthcare provider about all of your medical conditions, including if you:</span>\n<ul>\n<li>are currently taking or have recently taken medicines that lower the chance of blood clots forming in the body such as warfarin, low or regular doses of aspirin, or nonsteroidal anti-inflammatory drugs (NSAID).</li>\n<li>are pregnant or plan to become pregnant. It is not known if SUSVIMO will harm your unborn baby. You should use birth control during your treatment with SUSVIMO and for 12 months after your last dose of SUSVIMO. </li>\n<li>are breastfeeding or plan to breastfeed. It is not known if SUSVIMO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive SUSVIMO.</li>\n</ul>\n<span class=\"Bold\">Tell your healthcare provider about all the medicines you take,</span> including prescription and over-the-counter medicines, vitamins, and herbal supplements.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\"><a name=\"receive\"></a>How will I receive SUSVIMO?</span>\n<ul>\n<li>SUSVIMO is implanted through the white part of the eye (sclera) by your healthcare provider. </li>\n<li>Your healthcare provider will refill your implant device every 6 months (about every 24 weeks) if you have AMD or DME or every 9 months (about every 36 weeks) if you have DR.</li>\n<li>If you miss a scheduled refill, call your healthcare provider as soon as possible to reschedule your refill. Your next refill should be given 6 months after your last refill if you have AMD or DME, or 9 months after your last refill if you have DR.</li>\n</ul>Your healthcare provider will give you instructions to follow after the implant insertion, the refill procedure, and the implant removal. The instructions may include:<br/>\n<span class=\"Bold\">After the Implant Insertion:</span>\n<ul>\n<li>\n<span class=\"Bold\">Positioning of your head</span>\n<ul class=\"Circle\">\n<li>Keep your head above shoulder level for the rest of the day.</li>\n<li>Sleep with your head on 3 or more pillows during the day and night after your implant insertion.</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">How to care for your eye</span>\n<ul class=\"Circle\">\n<li>\n<span class=\"Bold\">Do not</span> remove the eye shield from your eye until you are told to by your healthcare provider. At bedtime, continue to wear an eye shield for <span class=\"Bold\">at least 7 nights</span> following the implant insertion.</li>\n<li>Take all post-operative eye medicines as your healthcare provider tells you to.</li>\n<li>\n<span class=\"Bold\">Do not</span> push on the eye, rub the eye, or touch the area of the eye where the implant is located (underneath the eyelid in the upper and outer part of your eye) for <span class=\"Bold\">30 days</span> following the implant insertion.</li>\n<li>\n<span class=\"Bold\">Do not</span> participate in strenuous activities until 1 month after the implant insertion or after talking to your healthcare provider.</li>\n</ul>\n</li>\n<li>\n<span class=\"Bold\">Magnetic Resonance Imaging (MRI) Implant Card</span>\n<ul class=\"Circle\">\n<li>Get your implant card from your healthcare provider after receiving the implant and keep the card in a safe place for future reference. The implant card contains important information about your SUSVIMO implant.</li>\n<li>Show your current and future healthcare providers your implant card. This is important if you need to have an MRI. You may only receive an MRI under very specific conditions if you have the SUSVIMO implant. Your healthcare provider will review the information on the implant card and will let you know if you should receive an MRI. </li>\n</ul>\n</li>\n</ul>\n<span class=\"Bold\">After the Refill Procedure:</span>\n<ul class=\"Circle\">\n<li>\n<span class=\"Bold\">Do not</span> push on the eye, rub the eye, or touch the area of the eye where the implant is located (underneath the eyelid in the upper and outer part of your eye) for <span class=\"Bold\">7 days</span> following the refill procedure.</li>\n<li>Take eye drops exactly as your healthcare provider tells you to take them.</li>\n</ul>\n<span class=\"Bold\">After the Implant Removal: </span>\n<ul class=\"Circle\">\n<li>Keep your head above shoulder level for the rest of the day.</li>\n<li>Sleep with your head on 3 or more pillows if lying down during the day and night after implant removal.</li>\n<li>Wear an eye shield for <span class=\"Bold\">at least 7 nights</span> following the implant removal.</li>\n<li>Do not participate in strenuous activities until <span class=\"Bold\">14 days</span> following the implant removal.</li>\n<li>Give all post-operative drops, as told by your healthcare provider.</li>\n</ul>These are not all the instructions you may receive from your healthcare provider. Following all post-procedure instructions may help prevent serious side effects or keep side effects from becoming more serious. See <span class=\"Bold\">\"<a href=\"#whatis\">What is the most important information I should know about SUSVIMO?</a>\"</span>.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What should I avoid while receiving SUSVIMO?</span>\n<ul>\n<li>\n<span class=\"Bold\">Do not</span> drive or use machinery until the eye shield can be removed and you can see.</li>\n<li>\n<span class=\"Bold\">Avoid</span> rubbing your eye or touching the area of your eye where the implant is located as much as possible while the implant is in place. If you have to rub or touch your eye, wash your hands first.</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\"><a name=\"sideeffects\"></a>What are the possible side effects of SUSVIMO?</span>\n<br/>See <span class=\"Bold\">\"<a href=\"#whatis\">What is the most important information I should know about SUSVIMO?</a>\"</span> on the first page.<br/>\n<span class=\"Bold\">In addition to those side effects listed on page one, the SUSVIMO implant and the procedures to insert, fill, refill and remove the eye (ocular) implant can cause other serious side effects including:</span>\n<ul>\n<li>\n<span class=\"Bold\">Tear and separation of layers of the retina (Rhegmatogenous retinal detachment).</span> Rhegmatogenous retinal detachment is a tear and separation of one of the layers of the retina in the back of the eye that senses light. Call your healthcare provider or go to the emergency room right away if you see flashing lights, see a curtain or veil covering part of your vision, have a change in your vision, or a loss of vision. Rhegmatogenous retinal detachment requires surgical treatment.</li>\n<li>\n<span class=\"Bold\">Implant movement (Implant dislocation):</span> Tell your healthcare provider right away if you notice that the implant has moved out of place. This movement may require surgical treatment to correct.</li>\n<li>\n<span class=\"Bold\">Implant damage</span>: Damage to the implant that prevents continued treatment (refills) with SUSVIMO. If the implant is not able to be properly refilled, your wet AMD may be inadequately treated and your physician may remove the implant and/or change your treatment.</li>\n<li>\n<span class=\"Bold\">Bleeding (Vitreous hemorrhage):</span> Vitreous hemorrhage is bleeding within the gel-like substance (vitreous) inside of your eye. Call your healthcare provider right away if you have an increase in moving spots or what looks like spider webs in your vision as you may need an additional eye surgery.</li>\n<li>\n<span class=\"Bold\">Bump on top of the white layer of the eye (Conjunctival bleb):</span> Conjunctival bleb is a small bulge in the layer (conjunctiva) that covers the white part of the eye where the implant is inserted. This may be due to leakage of fluid from the inside of the eye. Call your healthcare provider right away if you have a sudden feeling that something is in your eye (foreign body sensation), see a bulge over the white part of your eye, if you have eye discharge, or watering in the eye. You may need medical or surgical treatment.</li>\n<li>\n<span class=\"Bold\">Temporary decrease in vision after the SUSVIMO procedure.</span>\n</li>\n</ul>The most common side effects of SUSVIMO include:</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\">\n<ul>\n<li>blood on the white of the eye</li>\n<li>eye pain</li>\n</ul>\n</td><td align=\"left\" class=\"Rrule\">\n<ul>\n<li>redness in the white of the eye</li>\n<li>sensitivity to light</li>\n</ul>\n</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\">These are not all the possible side effects of SUSVIMO. <br/>\n<span class=\"Bold\">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</span>\n<br/>You may also report side effects to Genentech at 1-888-835-2555.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">General information about the safe and effective use of SUSVIMO.</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about SUSVIMO that is written for health professionals.</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\"><span class=\"Bold\">What are the ingredients in SUSVIMO (ranibizumab injection)?</span>\n<br/>\n<span class=\"Bold\">Active ingredient:</span> ranibizumab<br/>\n<span class=\"Bold\">Inactive ingredients:</span> histidine HCl, polysorbate 20, sucrose.<br/>Manufactured by: <span class=\"Bold\">Genentech, Inc.</span>, A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990<br/>U.S. License No.: 1048 </td>\n</tr>\n</tbody>\n</table></div>" }

Susvimo™ (ranibizumab injection)For Susvimo ocular implant useInstructions for Use

{ "type": "p", "children": [], "text": "\nSusvimo™\n(ranibizumab injection)For Susvimo ocular implant useInstructions for Use" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Toprule"><span class="Bold">Initial Fill and Implant Procedure</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Toprule\"><span class=\"Bold\">Initial Fill and Implant Procedure</span></td>\n</tr>\n</tbody>\n</table></div>" }

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

{ "type": "p", "children": [], "text": "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." }

Susvimo procedures should be performed by an ophthalmologist experienced in vitreoretinal surgery.

{ "type": "p", "children": [], "text": "Susvimo procedures should be performed by an ophthalmologist experienced in vitreoretinal surgery." }

Refer to the Susvimo (ranibizumab injection) 100 mg/mL prescribing information for a complete list of indications, contraindications, warnings, precautions, and adverse events.

{ "type": "p", "children": [], "text": "Refer to the Susvimo (ranibizumab injection) 100 mg/mL prescribing information for a complete list of indications, contraindications, warnings, precautions, and adverse events." }

Contents

{ "type": "p", "children": [], "text": "\nContents\n" }

Introduction

{ "type": "p", "children": [], "text": "\nIntroduction\n" }

<div class="scrollingtable"><table class="Noautorules" width="60%"> <col align="left" valign="middle" width="6%"/> <col align="left" valign="middle" width="94%"/> <tbody class="Headless"> <tr> <td align="left">3</td><td align="left">Device Description</td> </tr> <tr> <td align="left">4</td><td align="left">Components</td> </tr> <tr> <td align="left">8</td><td align="left">Intended Use/Indications for Use</td> </tr> <tr> <td align="left">8</td><td align="left">Contraindications</td> </tr> <tr> <td align="left">8</td><td align="left">Warnings</td> </tr> <tr> <td align="left">9</td><td align="left">Precautions</td> </tr> <tr> <td align="left">10</td><td align="left">How Supplied, Handling, and Storage</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"60%\">\n<col align=\"left\" valign=\"middle\" width=\"6%\"/>\n<col align=\"left\" valign=\"middle\" width=\"94%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\">3</td><td align=\"left\">Device Description</td>\n</tr>\n<tr>\n<td align=\"left\">4</td><td align=\"left\">Components</td>\n</tr>\n<tr>\n<td align=\"left\">8</td><td align=\"left\">Intended Use/Indications for Use</td>\n</tr>\n<tr>\n<td align=\"left\">8</td><td align=\"left\">Contraindications</td>\n</tr>\n<tr>\n<td align=\"left\">8</td><td align=\"left\">Warnings</td>\n</tr>\n<tr>\n<td align=\"left\">9</td><td align=\"left\">Precautions</td>\n</tr>\n<tr>\n<td align=\"left\">10</td><td align=\"left\">How Supplied, Handling, and Storage</td>\n</tr>\n</tbody>\n</table></div>" }

Instructions for Use

{ "type": "p", "children": [], "text": "\nInstructions for Use\n" }

<div class="scrollingtable"><table class="Noautorules" width="60%"> <col align="left" valign="middle" width="6%"/> <col align="left" valign="middle" width="94%"/> <tbody class="Headless"> <tr> <td align="left">11</td><td align="left">Introduction and Materials</td> </tr> <tr> <td align="left">13</td><td align="left">Preparatory Procedures</td> </tr> <tr> <td align="left">14</td><td align="left">Infusion Line Placement Procedure</td> </tr> <tr> <td align="left">15</td><td align="left">Conjunctival Dissection Procedure</td> </tr> <tr> <td align="left">17</td><td align="left">Syringe Preparation and Initial Implant Fill</td> </tr> <tr> <td align="left">25</td><td align="left">Implant Insertion</td> </tr> <tr> <td align="left">35</td><td align="left">Disposal and Post-insertion Procedures</td> </tr> <tr> <td align="left">36</td><td align="left">Explanation of symbols on product or package labeling</td> </tr> <tr> <td align="left">37</td><td align="left">Susvimo™ Implant Card</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"60%\">\n<col align=\"left\" valign=\"middle\" width=\"6%\"/>\n<col align=\"left\" valign=\"middle\" width=\"94%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\">11</td><td align=\"left\">Introduction and Materials</td>\n</tr>\n<tr>\n<td align=\"left\">13</td><td align=\"left\">Preparatory Procedures</td>\n</tr>\n<tr>\n<td align=\"left\">14</td><td align=\"left\">Infusion Line Placement Procedure</td>\n</tr>\n<tr>\n<td align=\"left\">15</td><td align=\"left\">Conjunctival Dissection Procedure</td>\n</tr>\n<tr>\n<td align=\"left\">17</td><td align=\"left\">Syringe Preparation and Initial Implant Fill</td>\n</tr>\n<tr>\n<td align=\"left\">25</td><td align=\"left\">Implant Insertion</td>\n</tr>\n<tr>\n<td align=\"left\">35</td><td align=\"left\">Disposal and Post-insertion Procedures</td>\n</tr>\n<tr>\n<td align=\"left\">36</td><td align=\"left\">Explanation of symbols on product or package labeling</td>\n</tr>\n<tr>\n<td align=\"left\">37</td><td align=\"left\">Susvimo™ Implant Card</td>\n</tr>\n</tbody>\n</table></div>" }

Introduction

{ "type": "p", "children": [], "text": "\nIntroduction\n" }

These instructions include only the procedure for filling and inserting the Susvimo implant. For more information, refer to the Susvimo prescribing information for the refill-exchange procedure and Susvimo Instructions for Use for the implant removal procedure.

{ "type": "p", "children": [], "text": "These instructions include only the procedure for filling and inserting the Susvimo implant. For more information, refer to the Susvimo prescribing information for the refill-exchange procedure and Susvimo Instructions for Use for the implant removal procedure." }

Device Description

{ "type": "p", "children": [], "text": "Device Description" }

Susvimo is an intraocular drug delivery system designed to be used specifically with Susvimo (ranibizumab injection) 100 mg/mL. The system consists of an intraocular implant along with ancillary devices used to fill, insert, and explant (if needed) the implant.

{ "type": "p", "children": [], "text": "Susvimo is an intraocular drug delivery system designed to be used specifically with Susvimo (ranibizumab injection) 100 mg/mL. The system consists of an intraocular implant along with ancillary devices used to fill, insert, and explant (if needed) the implant." }

The implant is a refillable drug reservoir that is inserted into the eye through the pars plana. The implant is secured within the scleral incision, with the extrascleral flange that remains visible through the conjunctiva following insertion. Once filled with ranibizumab, the implant is designed to provide continuous release of ranibizumab. The implant will be refilled with ranibizumab in an office-based setting via an administration through the conjunctiva and implant septum.

{ "type": "p", "children": [], "text": "The implant is a refillable drug reservoir that is inserted into the eye through the pars plana. The implant is secured within the scleral incision, with the extrascleral flange that remains visible through the conjunctiva following insertion. Once filled with ranibizumab, the implant is designed to provide continuous release of ranibizumab. The implant will be refilled with ranibizumab in an office-based setting via an administration through the conjunctiva and implant septum." }

Components

{ "type": "p", "children": [], "text": "Components" }

Figure 1

{ "type": "p", "children": [], "text": "\nFigure 1\n" }

Susvimo components for initial fill and implant procedure

{ "type": "p", "children": [], "text": "Susvimo components for initial fill and implant procedure" }

Susvimo implant (packaged with insertion tool assembly)

{ "type": "p", "children": [], "text": "\nSusvimo implant (packaged with insertion tool assembly)\n" }

Susvimo implant (Figure 2 and Figure 3) is a refillable reservoir inserted into the eye through the pars plana. The body of the implant, which includes the release control element, extends into the vitreous cavity.

{ "type": "p", "children": [], "text": "Susvimo implant (Figure 2 and Figure 3) is a refillable reservoir inserted into the eye through the pars plana. The body of the implant, which includes the release control element, extends into the vitreous cavity." }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <col align="left" valign="middle" width="50%"/> <col align="left" valign="middle" width="50%"/> <tbody class="Headless"> <tr> <td align="left"> <p class="First"> <a name="IFUfig2"></a><img alt="Figure 2" src="/dailymed/image.cfm?name=susvimo-33.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></p> </td><td align="left"> <p class="First"> <a name="IFUfig3"></a><img alt="Figure 3" src="/dailymed/image.cfm?name=susvimo-34.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></p> </td> </tr> <tr> <td align="left"><span class="Bold">Figure 2</span> <br/>Susvimo implant</td><td align="left"><span class="Bold">Figure 3</span> <br/>Susvimo implant detail</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<col align=\"left\" valign=\"middle\" width=\"50%\"/>\n<col align=\"left\" valign=\"middle\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig2\"></a><img alt=\"Figure 2\" src=\"/dailymed/image.cfm?name=susvimo-33.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></p>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig3\"></a><img alt=\"Figure 3\" src=\"/dailymed/image.cfm?name=susvimo-34.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">Figure 2</span>\n<br/>Susvimo implant</td><td align=\"left\"><span class=\"Bold\">Figure 3</span>\n<br/>Susvimo implant detail</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 1 Susvimo implant component description</span> </caption> <col align="left" valign="top" width="25%"/> <col align="left" valign="top" width="75%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Implant components</th><th align="left" class="Rrule">Description</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Extrascleral flange</td><td align="left" class="Rrule">The extrascleral flange provides secure anchoring of the implant within the scleral incision and is encased in silicone.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Septum</td><td align="left" class="Rrule">The septum is a self-sealing interface through which ranibizumab is administered into the implant both prior to insertion and during subsequent refills in an office-based setting.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Body</td><td align="left" class="Rrule">The body of the implant contains a hollow drug reservoir, capable of holding 0.02 mL of drug.</td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule Rrule">Release control element</td><td align="left" class="Rrule">The titanium release control element controls the rate of ranibizumab diffusion from the drug reservoir into the vitreous.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<caption>\n<span>Table 1\tSusvimo implant component description</span>\n</caption>\n<col align=\"left\" valign=\"top\" width=\"25%\"/>\n<col align=\"left\" valign=\"top\" width=\"75%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Lrule Rrule\">Implant components</th><th align=\"left\" class=\"Rrule\">Description</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\">Extrascleral flange</td><td align=\"left\" class=\"Rrule\">The extrascleral flange provides secure anchoring of the implant within the scleral incision and is encased in silicone.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Septum</td><td align=\"left\" class=\"Rrule\">The septum is a self-sealing interface through which ranibizumab is administered into the implant both prior to insertion and during subsequent refills in an office-based setting.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Body</td><td align=\"left\" class=\"Rrule\">The body of the implant contains a hollow drug reservoir, capable of holding 0.02 mL of drug.</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"left\" class=\"Lrule Rrule\">Release control element</td><td align=\"left\" class=\"Rrule\">The titanium release control element controls the rate of ranibizumab diffusion from the drug reservoir into the vitreous.</td>\n</tr>\n</tbody>\n</table></div>" }

Susvimo insertion tool assembly

{ "type": "p", "children": [], "text": "\nSusvimo insertion tool assembly\n" }

Susvimo insertion tool assembly is designed to facilitate handling of the implant during the initial fill and implant procedure. The insertion tool assembly is comprised of a carrier and handle (Figure 4 and Figure 5), described in more detail below:

{ "type": "p", "children": [], "text": "Susvimo insertion tool assembly is designed to facilitate handling of the implant during the initial fill and implant procedure. The insertion tool assembly is comprised of a carrier and handle (Figure 4 and Figure 5), described in more detail below:" }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <col align="left" valign="bottom" width="50%"/> <col align="left" valign="bottom" width="50%"/> <tbody class="Headless"> <tr> <td align="left"> <p class="First"> <a name="fig4a"></a><img alt="Figure 4" src="/dailymed/image.cfm?name=susvimo-35.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></p> </td><td align="left"> <p class="First"> <a name="fig5a"></a><img alt="Figure 5" src="/dailymed/image.cfm?name=susvimo-36.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></p> </td> </tr> <tr> <td align="left"><span class="Bold">Figure 4</span> <br/>Susvimo insertion tool carrier</td><td align="left"><span class="Bold">Figure 5</span> <br/>Susvimo insertion tool handle</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<col align=\"left\" valign=\"bottom\" width=\"50%\"/>\n<col align=\"left\" valign=\"bottom\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\">\n<p class=\"First\">\n<a name=\"fig4a\"></a><img alt=\"Figure 4\" src=\"/dailymed/image.cfm?name=susvimo-35.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></p>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"fig5a\"></a><img alt=\"Figure 5\" src=\"/dailymed/image.cfm?name=susvimo-36.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">Figure 4</span>\n<br/>Susvimo insertion tool carrier</td><td align=\"left\"><span class=\"Bold\">Figure 5</span>\n<br/>Susvimo insertion tool handle</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 2 Susvimo insertion tool assembly component description</span> </caption> <col align="left" valign="top" width="35%"/> <col align="left" valign="top" width="65%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Insertion tool assembly components</th><th align="left" class="Rrule">Description</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Gripper tips</td><td align="left" class="Rrule">The implant is provided pre-positioned in the insertion tool assembly gripper tips. After initial fill of the implant with ranibizumab, the implant and gripper tips are transferred from the insertion tool carrier to the insertion tool handle.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Luer lock slot</td><td align="left" class="Rrule">The syringe is loaded into the insertion tool carrier by aligning the syringe Luer lock with the insertion tool carrier Luer lock slot.</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Guide channel</td><td align="left" class="Rrule">The guide channel serves to direct the syringe and initial fill needle in the insertion tool carrier during the initial fill of the implant.</td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule Rrule">Release button</td><td align="left" class="Rrule">Pressing the release button on the insertion tool handle will open the gripper tips and release the implant.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<caption>\n<span>Table 2\tSusvimo insertion tool assembly component description</span>\n</caption>\n<col align=\"left\" valign=\"top\" width=\"35%\"/>\n<col align=\"left\" valign=\"top\" width=\"65%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Lrule Rrule\">Insertion tool assembly components</th><th align=\"left\" class=\"Rrule\">Description</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\">Gripper tips</td><td align=\"left\" class=\"Rrule\">The implant is provided pre-positioned in the insertion tool assembly gripper tips. After initial fill of the implant with ranibizumab, the implant and gripper tips are transferred from the insertion tool carrier to the insertion tool handle.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Luer lock slot</td><td align=\"left\" class=\"Rrule\">The syringe is loaded into the insertion tool carrier by aligning the syringe Luer lock with the insertion tool carrier Luer lock slot.</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Guide channel</td><td align=\"left\" class=\"Rrule\">The guide channel serves to direct the syringe and initial fill needle in the insertion tool carrier during the initial fill of the implant.</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"left\" class=\"Lrule Rrule\">Release button</td><td align=\"left\" class=\"Rrule\">Pressing the release button on the insertion tool handle will open the gripper tips and release the implant.</td>\n</tr>\n</tbody>\n</table></div>" }

Susvimo (ranibizumab injection) 100 mg/mL vial

{ "type": "p", "children": [], "text": "\nSusvimo (ranibizumab injection) 100 mg/mL vial\n" }

Susvimo (ranibizumab injection) (Figure 6) is used to fill the implant prior to insertion or during subsequent refill-exchange in an office-based setting.

{ "type": "p", "children": [], "text": "Susvimo (ranibizumab injection) (Figure 6) is used to fill the implant prior to insertion or during subsequent refill-exchange in an office-based setting." }

Figure 6 Susvimo (ranibizumab injection) 100 mg/mL vial

{ "type": "p", "children": [], "text": "\nFigure 6\nSusvimo (ranibizumab injection) 100 mg/mL vial" }

Susvimo initial fill needle

{ "type": "p", "children": [], "text": "\nSusvimo initial fill needle\n" }

Susvimo initial fill needle (Figure 7) is designed to fill the implant with ranibizumab prior to implant insertion. The initial fill needle is distinguished by its blue cap.

{ "type": "p", "children": [], "text": "Susvimo initial fill needle (Figure 7) is designed to fill the implant with ranibizumab prior to implant insertion. The initial fill needle is distinguished by its blue cap." }

Figure 7 Susvimo initial fill needle

{ "type": "p", "children": [], "text": "\nFigure 7\nSusvimo initial fill needle" }

<div class="scrollingtable"><table width="65%"> <caption> <span>Table 3 Susvimo initial fill needle component description</span> </caption> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Initial fill needle components</th><th align="left" class="Rrule">Description</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Needle</td><td align="left" class="Rrule">34 G needle</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Integrated filter</td><td align="left" class="Rrule">Integrated 5 µm filter within needle hub</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"65%\">\n<caption>\n<span>Table 3\tSusvimo initial fill needle component description</span>\n</caption>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Lrule Rrule\">Initial fill needle components</th><th align=\"left\" class=\"Rrule\">Description</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\">Needle</td><td align=\"left\" class=\"Rrule\">34 G needle</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\">Integrated filter</td><td align=\"left\" class=\"Rrule\">Integrated 5 µm filter within needle hub</td>\n</tr>\n</tbody>\n</table></div>" }

Intended Use/Indications for Use

{ "type": "p", "children": [], "text": "Intended Use/Indications for Use" }

Susvimo ocular implant is approved for use with Susvimo (ranibizumab injection). Refer to the Susvimo (ranibizumab injection) prescribing information for a complete list of indications, contraindications, warnings, precautions, and adverse events.

{ "type": "p", "children": [], "text": "Susvimo ocular implant is approved for use with Susvimo (ranibizumab injection). Refer to the Susvimo (ranibizumab injection) prescribing information for a complete list of indications, contraindications, warnings, precautions, and adverse events." }

Contraindications

{ "type": "p", "children": [], "text": "Contraindications" }

Susvimo is contraindicated in patients with ocular or periocular infections, with active intraocular inflammation, or with known hypersensitivity to ranibizumab or any of the excipients in Susvimo (ranibizumab injection) 100 mg/mL. Hypersensitivity reactions may manifest as severe intraocular inflammation.

{ "type": "p", "children": [], "text": "Susvimo is contraindicated in patients with ocular or periocular infections, with active intraocular inflammation, or with known hypersensitivity to ranibizumab or any of the excipients in Susvimo (ranibizumab injection) 100 mg/mL. Hypersensitivity reactions may manifest as severe intraocular inflammation." }

Warnings

{ "type": "p", "children": [], "text": "Warnings" }

{ "type": "ul", "children": [ "\nDo not use if the sterility has been compromised or the contents have been dropped, damaged or tampered with.", "Minimize air bubbles within the implant reservoir as they may cause slower drug release. If an air bubble is present, it must be no larger than 1/3 of the widest diameter of the implant.If excess air is observed after initial fill, do not use the implant.", "Perpendicular entry of the implant is important to avoid contact between the implant and intraocular structures such as the lens, as contact between the implant and the intraocular structures may cause adverse events such as traumatic cataract.", "Avoid excessive force on the globe by first ensuring that the tip of the implant has passed through the sclero-pars plana incision before slowly pushing the implant into place." ], "text": "" }

Precautions

{ "type": "p", "children": [], "text": "Precautions" }

{ "type": "ul", "children": [ "Read and follow all instructions, warnings, and cautions prior to use.", "Susvimo procedures should be performed by an ophthalmologist experienced in vitreoretinal surgery.", "Use the Susvimo components and materials as specified in these instructions to perform the implant insertion procedure including initial fill.", "Avoid contact between sharp surgical instruments and the implant as the material of the septum and silicone encasing are soft and susceptible to damage.", "The implant is MR Conditional. The Patient Implant card is provided with instructions and must be completed and given to the patient after implant insertion. For further information please refer to the 'Post-insertion patient instructions' section." ], "text": "" }

Use with Standard Procedures

{ "type": "p", "children": [], "text": "\nUse with Standard Procedures\n" }

Susvimo implant is compatible for use with the following standard procedures: A-scan ophthalmic ultrasound, slit lamp examination, indirect ophthalmoscopy, tonometry, optical coherence tomography (OCT), visual field (perimetry), standard lasers for ophthalmic treatments, radiography (x-ray), computed tomography (CT) scan, fluorescein/ indocyanine angiography, and fundus autofluorescence.

{ "type": "p", "children": [], "text": "Susvimo implant is compatible for use with the following standard procedures: A-scan ophthalmic ultrasound, slit lamp examination, indirect ophthalmoscopy, tonometry, optical coherence tomography (OCT), visual field (perimetry), standard lasers for ophthalmic treatments, radiography (x-ray), computed tomography (CT) scan, fluorescein/ indocyanine angiography, and fundus autofluorescence." }

Use caution when performing ophthalmic procedures that may cause deflection of the implant and subsequent injury. For example, B-scan ophthalmic ultrasound, scleral depression, or gonioscopy.

{ "type": "p", "children": [], "text": "Use caution when performing ophthalmic procedures that may cause deflection of the implant and subsequent injury. For example, B-scan ophthalmic ultrasound, scleral depression, or gonioscopy." }

Magnetic Resonance Imaging (MRI) Safety Information

{ "type": "p", "children": [], "text": "\nMagnetic Resonance Imaging (MRI) Safety Information\n" }

MR Conditional.

{ "type": "p", "children": [], "text": "\nMR Conditional." }

Non-clinical testing has demonstrated that the Susvimo implant is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

{ "type": "p", "children": [], "text": "Non-clinical testing has demonstrated that the Susvimo implant is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:" }

{ "type": "ul", "children": [ "Static magnetic field of 1.5-Tesla (1.5 T) or 3-Tesla (3 T)", "Maximum spatial field gradient of 3,000 G/cm (30 T/m)", "Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4.0 W/kg (First Level Controlled Operating Mode)" ], "text": "" }

Under the scan conditions defined above, the Susvimo implant is expected to produce a maximum temperature rise of less than 1°C after 15 minutes of continuous scanning.

{ "type": "p", "children": [], "text": "Under the scan conditions defined above, the Susvimo implant is expected to produce a maximum temperature rise of less than 1°C after 15 minutes of continuous scanning." }

In non-clinical testing, the image artifact caused by the device extends approximately 4 mm from the Susvimo implant when imaged with a gradient echo pulse sequence in a 3 T MRI system.

{ "type": "p", "children": [], "text": "In non-clinical testing, the image artifact caused by the device extends approximately 4 mm from the Susvimo implant when imaged with a gradient echo pulse sequence in a 3 T MRI system." }

How Supplied, Handling, and Storage

{ "type": "p", "children": [], "text": "How Supplied, Handling, and Storage" }

{ "type": "ul", "children": [ "All Susvimo components are supplied sterile.\nDo not reprocess or resterilize.", "All Susvimo components are for single use only.\nDo not reuse Susvimo components.", "\nDo not open sealed tray until time of use.", "\nDo not use if the package is damaged or broken as sterility may be compromised.", "\nDo not use past the expiration date printed on the label." ], "text": "" }

Susvimo ocular implant and insertion tool assembly

{ "type": "p", "children": [], "text": "\nSusvimo ocular implant and insertion tool assembly\n" }

{ "type": "ul", "children": [ "The sealed tray has been sterilized with ethylene oxide gas.", "Store the Susvimo implant and insertion tool assembly at room temperature 15°C to 25°C (59°F to 77°F)." ], "text": "" }

Susvimo (ranibizumab injection) and initial fill needle kit

{ "type": "p", "children": [], "text": "\nSusvimo (ranibizumab injection) and initial fill needle kit\n" }

{ "type": "ul", "children": [ "Susvimo initial fill kit should be stored at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake. Prior to use, the unopened vial may be kept at 9°C to 30°C (48°F to 86°F) for up to 24 hours.", "Susvimo initial fill needle has been sterilized with electron beam processing." ], "text": "" }

See Susvimo (ranibizumab injection) prescribing information for additional information.

{ "type": "p", "children": [], "text": "See Susvimo (ranibizumab injection) prescribing information for additional information." }

Instructions for Use

{ "type": "p", "children": [], "text": "\nInstructions for Use\n" }

Introduction and Materials

{ "type": "p", "children": [], "text": "Introduction and Materials" }

Implant insertion is a surgical procedure that is performed in an operating room. The implant is filled with Susvimo (ranibizumab injection) immediately prior to insertion.

{ "type": "p", "children": [], "text": "Implant insertion is a surgical procedure that is performed in an operating room. The implant is filled with Susvimo (ranibizumab injection) immediately prior to insertion." }

Materials List

{ "type": "p", "children": [], "text": "\nMaterials List\n" }

The materials that are required in the operating room on the day of the procedure are listed in Tables 4 and 5.

{ "type": "p", "children": [], "text": "The materials that are required in the operating room on the day of the procedure are listed in Tables 4 and 5." }

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 4 Susvimo components provided for initial fill and implant procedure </span> </caption> <col align="left" valign="middle" width="100%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Item Description</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Susvimo ocular implant with insertion tool assembly</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Susvimo initial fill needle, 34 G, with blue cap</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Susvimo (ranibizumab injection) 100 mg/mL</td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule Rrule">Susvimo explant tool <br/>(Refer to Susvimo implant removal <a href="#IFUb">Instructions for Use</a> for information on implant removal.)</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<caption>\n<span>Table 4\tSusvimo components provided for initial fill and implant procedure </span>\n</caption>\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Lrule Rrule\">Item Description</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\">Susvimo ocular implant with insertion tool assembly</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Susvimo initial fill needle, 34 G, with blue cap</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Susvimo (ranibizumab injection) 100 mg/mL</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"left\" class=\"Lrule Rrule\">Susvimo explant tool <br/>(Refer to Susvimo implant removal <a href=\"#IFUb\">Instructions for Use</a> for information on implant removal.)</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 5 Additional materials required but not provided for initial fill and implant procedure</span> </caption> <col align="left" valign="middle" width="100%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Item Description</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">One sterile 1 mL Luer Lock syringe <span class="Bold">(not included)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">One sterile 5-micron filter needle (19-gauge × 1½ inch) <span class="Bold">(not included)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Surgical microscope</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Vitrectomy surgical control system</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Standard 25 G or 27 G vitrectomy set up</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">23 G or 25 G 532 nm Endolaser probe and associated source</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Standard vitrectomy tray <span class="Italics">(including adjustable caliper, 0.12 straight toothed forceps, blunt wescott scissors)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Cauterization equipment <span class="Italics">(including standard fine tip diathermy and eraser tip wet-field cautery)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Ophthalmic broad-spectrum microbicide solution</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Marking pad</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">3.5 mm and 4.0 mm fixed caliper <span class="Italics">or equivalent fixed tool</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">3.5 mm fixed width gauge <span class="Italics">or equivalent fixed tool</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">19 G or 20 G MVR Straight Knife</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Slit Knife, 3.2 mm Straight</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Gut or Vicryl sutures for conjunctival tissues <span class="Italics">(suggested 7-0 to 9-0: monofilament recommended)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Indirect ophthalmoscope and lens</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule">Drapes</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<caption>\n<span>Table 5\tAdditional materials required but not provided for initial fill and implant procedure</span>\n</caption>\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Lrule Rrule\">Item Description</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\">One sterile 1 mL Luer Lock syringe <span class=\"Bold\">(not included)</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">One sterile 5-micron filter needle (19-gauge × 1½ inch) <span class=\"Bold\">(not included)</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Surgical microscope</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Vitrectomy surgical control system</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Standard 25 G or 27 G vitrectomy set up</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">23 G or 25 G 532 nm Endolaser probe and associated source</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Standard vitrectomy tray <span class=\"Italics\">(including adjustable caliper, 0.12 straight toothed forceps, blunt wescott scissors)</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Cauterization equipment <span class=\"Italics\">(including standard fine tip diathermy and eraser tip wet-field cautery)</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Ophthalmic broad-spectrum microbicide solution</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Marking pad</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">3.5 mm and 4.0 mm fixed caliper <span class=\"Italics\">or equivalent fixed tool</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">3.5 mm fixed width gauge <span class=\"Italics\">or equivalent fixed tool</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">19 G or 20 G MVR Straight Knife</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Slit Knife, 3.2 mm Straight</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Gut or Vicryl sutures for conjunctival tissues <span class=\"Italics\">(suggested 7-0 to 9-0: monofilament recommended)</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Indirect ophthalmoscope and lens</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Lrule Rrule\">Drapes</td>\n</tr>\n</tbody>\n</table></div>" }

Preparatory Procedures

{ "type": "p", "children": [], "text": "Preparatory Procedures" }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="left"><span class="Bold">1. Inspect packaging and components</span> <ul> <li>Prior to use in the operating room, inspect the packaging of the components for damage.</li> <li>Check the expiration date printed on the label.</li> <li>Remove the vial from the carton. <br/>NOTE: the outside of the vial is not sterile.</li> <li>Open sterile packaging and using aseptic technique, remove the components from their tray.</li> <li>Inspect components and place onto sterile field (<a href="#fig8a">Figure 8</a>).</li> </ul> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-40.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Warning</span> <br/> <span class="Bold">Do not</span> use if the sterility has been compromised or the contents have been dropped, damaged, or tampered with.</p> </td><td align="left"> <p class="First"> <a name="fig8a"></a><img alt="Figure 8" src="/dailymed/image.cfm?name=susvimo-41.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 8</span> <br/>Susvimo components on sterile field</p> </td> </tr> <tr> <td align="left" colspan="2"><span class="Bold">2. Inspect Susvimo (ranibizumab injection)</span> <ul> <li>Visually inspect the contents of the ranibizumab vial for particulate matter and discoloration.</li> <li>The drug solution should be colorless to pale brown.</li> </ul> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-42.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/> <span class="Bold">Do not</span> use if particulate, cloudiness or discoloration are visible.</p> </td> </tr> <tr> <td align="left" colspan="2"><span class="Bold">3. Patient Preparation</span> <ul> <li>Dilate the pupil of the eye.</li> <li>Place the patient in a supine position on the operating table.</li> <li>Implant insertion is a surgical procedure and therefore requires sterile controls (i.e. use of broad-spectrum microbicide solution on eye including lids and lashes and draping) be in place to minimize the risk of ocular infection.</li> <li>Perform the procedure under local anesthesia using either peribulbar, retrobulbar, or sub-Tenon's technique.</li> <li>Place lid speculum.</li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"><span class=\"Bold\">1.\tInspect packaging and components</span>\n<ul>\n<li>Prior to use in the operating room, inspect the packaging of the components for damage.</li>\n<li>Check the expiration date printed on the label.</li>\n<li>Remove the vial from the carton. <br/>NOTE: the outside of the vial is not sterile.</li>\n<li>Open sterile packaging and using aseptic technique, remove the components from their tray.</li>\n<li>Inspect components and place onto sterile field (<a href=\"#fig8a\">Figure 8</a>).</li>\n</ul>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-40.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Warning</span>\n<br/>\n<span class=\"Bold\">Do not</span> use if the sterility has been compromised or the contents have been dropped, damaged, or tampered with.</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"fig8a\"></a><img alt=\"Figure 8\" src=\"/dailymed/image.cfm?name=susvimo-41.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 8</span>\n<br/>Susvimo components on sterile field</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"2\"><span class=\"Bold\">2.\tInspect Susvimo (ranibizumab injection)</span>\n<ul>\n<li>Visually inspect the contents of the ranibizumab vial for particulate matter and discoloration.</li>\n<li>The drug solution should be colorless to pale brown.</li>\n</ul>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-42.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>\n<span class=\"Bold\">Do not</span> use if particulate, cloudiness or discoloration are visible.</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"2\"><span class=\"Bold\">3.\tPatient Preparation</span>\n<ul>\n<li>Dilate the pupil of the eye.</li>\n<li>Place the patient in a supine position on the operating table.</li>\n<li>Implant insertion is a surgical procedure and therefore requires sterile controls (i.e. use of broad-spectrum microbicide solution on eye including lids and lashes and draping) be in place to minimize the risk of ocular infection.</li>\n<li>Perform the procedure under local anesthesia using either peribulbar, retrobulbar, or sub-Tenon's technique.</li>\n<li>Place lid speculum.</li>\n</ul>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Infusion Line Placement Procedure

{ "type": "p", "children": [], "text": "Infusion Line Placement Procedure" }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="left"><span class="Bold">1. Place infusion line</span> <ul> <li>Place an infusion cannula in the inferotemporal quadrant via an angled entry wound.<dl> <dt>–</dt> <dd>Alternate placement is acceptable based on patient anatomy per physician discretion (superotemporal placement should be avoided).</dd> <dt>–</dt> <dd>Alternatively, the line may be placed after the peritomy but prior to the scleral dissection.</dd> </dl> </li> <li>Attach the infusion line. Keep the infusion line off (<a href="#fig9a">Figure 9</a>).</li> </ul> </td><td align="left"> <p class="First"> <a name="fig9a"></a><img alt="Figure 9" src="/dailymed/image.cfm?name=susvimo-43.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 9</span> <br/>Place infusion cannula in inferotemporal quadrant</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"><span class=\"Bold\">1.\tPlace infusion line</span>\n<ul>\n<li>Place an infusion cannula in the inferotemporal quadrant via an angled entry wound.<dl>\n<dt>–</dt>\n<dd>Alternate placement is acceptable based on patient anatomy per physician discretion (superotemporal placement should be avoided).</dd>\n<dt>–</dt>\n<dd>Alternatively, the line may be placed after the peritomy but prior to the scleral dissection.</dd>\n</dl>\n</li>\n<li>Attach the infusion line. Keep the infusion line off (<a href=\"#fig9a\">Figure 9</a>).</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"fig9a\"></a><img alt=\"Figure 9\" src=\"/dailymed/image.cfm?name=susvimo-43.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 9</span>\n<br/>Place infusion cannula in inferotemporal quadrant</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Conjunctival Dissection Procedure

{ "type": "p", "children": [], "text": "Conjunctival Dissection Procedure" }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="left"><span class="Bold">1. Identify the site of insertion</span> <ul> <li>Identify the site in the superotemporal quadrant 4 mm posterior to the limbus where the implant will be inserted (<a href="#fig10a">Figure 10</a> and <a href="#fig11a">Figure 11</a>).</li> <li>Placing a traction suture is strongly recommended for better visualization of the superotemporal quadrant throughout the entire implant insertion procedure. </li> </ul> </td><td align="left"> <p class="First"> <a name="fig10a"></a><img alt="Figure 10" src="/dailymed/image.cfm?name=susvimo-44.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 10</span> <br/>Superotemporal quadrant<br/> <a name="fig11a"></a><img alt="Figure 11" src="/dailymed/image.cfm?name=susvimo-45.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 11</span> <br/>4 mm posterior to the limbus</p> </td> </tr> <tr> <td align="left" colspan="2"><span class="Bold">2. Create conjunctival peritomy</span></td> </tr> <tr> <td align="left" colspan="2"> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-46.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>The peritomy size should be at least 6 mm by 6 mm centered around the selected implant location to ensure the proper clearance of the conjunctiva and Tenon's capsule from the implant flange once the implant is inserted into the eye.</p> </td> </tr> <tr> <td align="left"> <ul> <li>Measure with adjustable caliper and create at least a 6mm by 6mm peritomy of the conjunctiva and Tenon's capsule around the selected implant location, using wet field cautery (eraser tip) to achieve hemostasis of the underlying episcleral tissues (<a href="#fig12a">Figure 12</a>).<dl> <dt>–</dt> <dd>A peritomy size of at least 6 mm by 6 mm centered around the selected implant location provides proper clearance of the conjunctiva and Tenon's capsule for the implant flange (long axis of implant flange = 4.6 mm).</dd> <dt>–</dt> <dd>A peritomy size of at least 6 mm by 6 mm facilitates implant placement away from radial relaxing incision.</dd> <dt>–</dt> <dd>Appropriate peritomy size is vital for ease of subsequent surgery.</dd> </dl> </li> </ul> </td><td align="left"> <p class="First"> <a name="fig12a"></a><img alt="Figure 12" src="/dailymed/image.cfm?name=susvimo-47.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 12</span> <br/>Conjunctival peritomy with blue dot representing selected implant location</p> </td> </tr> <tr> <td align="left" colspan="2"> <dl> <dt>–</dt> <dd>Only one radial incision is recommended, to avoid excessive conjunctival suturing and longer healing process.</dd> <dt>–</dt> <dd>Careful incision creation is key to maintain integrity of conjunctiva and Tenon's capsule. Careful and generous undermining is key to minimize mechanical tension and adequate coverage of the implant while closing the conjunctiva and Tenon's capsule.</dd> </dl> <ul> <li>Maintain hemostasis around the scleral incision throughout the surgery to facilitate the identification and management of incisional bleeding, to avoid post-operative vitreous hemorrhage.</li> </ul> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"><span class=\"Bold\">1.\tIdentify the site of insertion</span>\n<ul>\n<li>Identify the site in the superotemporal quadrant 4 mm posterior to the limbus where the implant will be inserted (<a href=\"#fig10a\">Figure 10</a> and <a href=\"#fig11a\">Figure 11</a>).</li>\n<li>Placing a traction suture is strongly recommended for better visualization of the superotemporal quadrant throughout the entire implant insertion procedure. </li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"fig10a\"></a><img alt=\"Figure 10\" src=\"/dailymed/image.cfm?name=susvimo-44.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 10</span>\n<br/>Superotemporal quadrant<br/>\n<a name=\"fig11a\"></a><img alt=\"Figure 11\" src=\"/dailymed/image.cfm?name=susvimo-45.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 11</span>\n<br/>4 mm posterior to the limbus</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"2\"><span class=\"Bold\">2.\tCreate conjunctival peritomy</span></td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"2\">\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-46.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>The peritomy size should be at least 6 mm by 6 mm centered around the selected implant location to ensure the proper clearance of the conjunctiva and Tenon's capsule from the implant flange once the implant is inserted into the eye.</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\">\n<ul>\n<li>Measure with adjustable caliper and create at least a 6mm by 6mm peritomy of the conjunctiva and Tenon's capsule around the selected implant location, using wet field cautery (eraser tip) to achieve hemostasis of the underlying episcleral tissues (<a href=\"#fig12a\">Figure 12</a>).<dl>\n<dt>–</dt>\n<dd>A peritomy size of at least 6 mm by 6 mm centered around the selected implant location provides proper clearance of the conjunctiva and Tenon's capsule for the implant flange (long axis of implant flange = 4.6 mm).</dd>\n<dt>–</dt>\n<dd>A peritomy size of at least 6 mm by 6 mm facilitates implant placement away from radial relaxing incision.</dd>\n<dt>–</dt>\n<dd>Appropriate peritomy size is vital for ease of subsequent surgery.</dd>\n</dl>\n</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"fig12a\"></a><img alt=\"Figure 12\" src=\"/dailymed/image.cfm?name=susvimo-47.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 12</span>\n<br/>Conjunctival peritomy with blue dot representing selected implant location</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"2\">\n<dl>\n<dt>–</dt>\n<dd>Only one radial incision is recommended, to avoid excessive conjunctival suturing and longer healing process.</dd>\n<dt>–</dt>\n<dd>Careful incision creation is key to maintain integrity of conjunctiva and Tenon's capsule. Careful and generous undermining is key to minimize mechanical tension and adequate coverage of the implant while closing the conjunctiva and Tenon's capsule.</dd>\n</dl>\n<ul>\n<li>Maintain hemostasis around the scleral incision throughout the surgery to facilitate the identification and management of incisional bleeding, to avoid post-operative vitreous hemorrhage.</li>\n</ul>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Syringe Preparation and Initial Implant Fill

{ "type": "p", "children": [], "text": "Syringe Preparation and Initial Implant Fill" }

Using aseptic technique, the implant will be filled with 0.02 mL of ranibizumab prior to insertion of the implant into the patient's eye.

{ "type": "p", "children": [], "text": "Using aseptic technique, the implant will be filled with 0.02 mL of ranibizumab prior to insertion of the implant into the patient's eye." }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="left"> <p class="First"> <span class="Bold">1. Transfer dose from vial to syringe</span> <br/> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-48.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>Use the filter needle to withdraw ranibizumab from the vial.<br/> <span class="Bold">Do not</span> use the initial fill needle for this step.</p> <ul> <li>Prepare ranibizumab vial by removing the flip-off cap and disinfecting the rubber vial septum with alcohol.</li> <li>Attach a filter needle to the syringe by screwing it tightly onto the Luer lock (<a href="#fig13a">Figure 13</a>).</li> <li>Carefully remove the needle cap by pulling it straight off.</li> <li>Using aseptic technique, withdraw all of the contents of the ranibizumab vial through the filter needle into the syringe.</li> </ul> </td><td align="left"> <p class="First"> <a name="fig13a"></a><img alt="Figure 13" src="/dailymed/image.cfm?name=susvimo-49.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 13</span> <br/>Filter needle attached to syringe and cap removal</p> </td> </tr> <tr> <td align="left"><span class="Bold">2. Remove air from syringe</span> <ul> <li>With the filter needle attached, hold the syringe with the needle pointing up.</li> <li>If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (<a href="#IFUfig14">Figure 14</a>).</li> <li>Slowly push the plunger rod just until all air is expelled from the syringe and needle.<dl> <dt>–</dt> <dd>It is important to preserve as much drug as possible in order to completely fill the implant.</dd> </dl> </li> <li>Remove and properly dispose of the filter needle after air is removed from syringe.</li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig14"></a><img alt="Figure 14" src="/dailymed/image.cfm?name=susvimo-48a.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 14</span> <br/>No air bubbles in syringe</p> </td> </tr> <tr> <td align="left"><span class="Bold">3. Attach initial fill needle</span> <ul> <li>Attach the initial fill needle firmly onto the syringe by screwing it tightly onto the Luer lock (<a href="#IFUfig15a">Figure 15</a>).</li> <li>Carefully remove the needle cap by pulling straight off.</li> </ul> <ul> <li> <span class="Bold">Do not</span> wipe the needle at any time.</li> </ul> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-50.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>Ensure that the initial fill needle is attached to the syringe.<br/> <span class="Bold">Do not</span> use the filter needle to fill the implant.</p> </td><td align="left"> <p class="First"> <a name="IFUfig15a"></a><img alt="Figure 15" src="/dailymed/image.cfm?name=susvimo-51.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 15</span> <br/>Initial fill needle attached to syringe and cap removal</p> </td> </tr> <tr> <td align="left"><span class="Bold">4. Remove any remaining air from syringe</span> <ul> <li>With the initial fill needle attached, hold the syringe with the needle pointing up.</li> <li>If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (<a href="#IFUfig16">Figure 16</a>).</li> <li>Slowly push the plunger rod just until all air is expelled from the syringe and needle, and a drop of drug solution is seen at the needle tip (<a href="#IFUfig17">Figure 17</a>).<dl> <dt>–</dt> <dd>It is important to preserve as much drug as possible in order to completely fill the implant.</dd> </dl> </li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig16"></a><img alt="Figure 16" src="/dailymed/image.cfm?name=susvimo-52.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 16</span> <br/>Gently tap the syringe to dislodge bubbles<br/> <a name="IFUfig17"></a><img alt="Figure 17" src="/dailymed/image.cfm?name=susvimo-53.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 17</span> <br/>No air bubbles and a drop of drug at the needle tip</p> </td> </tr> <tr> <td align="left"><span class="Bold">5. Inspect the syringe for air bubbles</span> <ul> <li>Inspect the syringe and the needle hub to ensure that no air bubbles are present (<a href="#IFUfig18">Figure 18</a>).</li> <li>If air bubbles are present, continue to remove air from the syringe and reinspect.</li> </ul> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-54.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>Use the syringe within <span class="Bold Underline">15 minutes</span> of removing all air to avoid ranibizumab drying in the needle and impeding fluid flow.<br/> <span class="Bold">Do not</span> use the initial fill needle if the needle is clogged.</p> </td><td align="left"> <p class="First"> <a name="IFUfig18"></a><img alt="Figure 18" src="/dailymed/image.cfm?name=susvimo-55.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 18</span> <br/>No air bubbles in the syringe and needle hub</p> </td> </tr> <tr> <td align="left"> <p class="First"> <span class="Bold">6. Load syringe into the carrier</span> <br/> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-56.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/> <span class="Bold">Do not</span> hold or push on the plunger rod of the syringe while inserting the needle into the implant septum.</p> <ul> <li>Retrieve insertion tool carrier with pre-positioned implant from the inner tray.</li> <li>Align the syringe Luer lock above the Luer lock slot in the carrier to protect the needle from being damaged.</li> <li>Lower the syringe into the carrier (<a href="#IFUfig19">Figure 19</a>).</li> <li>Push the syringe forward until it stops, taking care to avoid touching the plunger rod (<a href="#IFUfig20">Figure 20</a>).</li> <li>With the syringe loaded, (<a href="#IFUfig21">Figure 21</a>) the initial fill needle should now be penetrating the implant septum.</li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig19"></a><img alt="Figure 19" src="/dailymed/image.cfm?name=susvimo-57.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 19</span> <br/>Align and lower the syringe into the carrier<br/> <a name="IFUfig20"></a><img alt="Figure 20" src="/dailymed/image.cfm?name=susvimo-58.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 20</span> <br/>Push the syringe into the carrier<br/> <a name="IFUfig21"></a><img alt="Figure 21" src="/dailymed/image.cfm?name=susvimo-59.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 21</span> <br/>Syringe with initial fill needle inserted through the implant septum</p> </td> </tr> <tr> <td align="left"><span class="Bold">7. Fill implant with ranibizumab under microscope</span> <ul> <li>Under the microscope, <span class="Bold Underline">slowly</span> administer ranibizumab into the implant by slightly tilting the carrier upwards (<a href="#IFUfig22">Figure 22</a>).</li> <li>The implant should be filled over approximately <span class="Bold Underline">5 to 10 seconds</span>, to help avoid air entrapment in the implant reservoir.</li> <li>Continue filling the implant until the implant is completely full of drug solution and all air has been expelled as evidenced by a dome of drug solution formed at the tip of the implant on the release control element (<a href="#IFUfig23">Figure 23</a>).<br/> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-60.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>When filling the implant, fluid should only exit the implant from the release control element. If fluid is leaking from the implant at a different location, such as the side of the implant, <span class="Bold">do not</span> use the implant. <br/>If fluid is leaking from the septum at the needle insertion site, the needle may not be fully penetrating the implant septum. Fully push the syringe forward before continuing to fill the implant. </p> </li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig22"></a><img alt="Figure 22" src="/dailymed/image.cfm?name=susvimo-61.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 22</span> <br/>Administer ranibizumab into the implant<br/> <a name="IFUfig23"></a><img alt="Figure 23" src="/dailymed/image.cfm?name=susvimo-62.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 23</span> <br/>Dome of drug solution forms at tip of implant as viewed under magnification</p> </td> </tr> <tr> <td align="left"><span class="Bold">8. Inspect the filled implant under the microscope</span> <ul> <li> <p class="First">Inspect the implant under the microscope to ensure that the implant is completely full of drug solution (<a href="#IFUfig24">Figure 24</a>).<br/> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-63.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Warning</span> <br/>Minimize air bubbles within the implant reservoir as they may cause slower drug release. If an air bubble is present, it must be no larger than 1/3 of the widest diameter of the implant.<br/>If excess air is observed, <span class="Bold">do not</span> use the implant.<br/> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-64.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>No more than <span class="Bold Underline">30 minutes</span> should pass between the initial fill of the implant and the insertion into the patient's eye to ensure that the release control element remains saturated with ranibizumab. If ranibizumab dries in the release control element, the implant may not release the drug properly into the vitreous after insertion.</p> </li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig24"></a><img alt="Figure 24" src="/dailymed/image.cfm?name=susvimo-65.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 24</span> <br/>Proper appearance of implant after initial filling with ranibizumab</p> </td> </tr> <tr> <td align="left" colspan="2"><span class="Bold">9. Remove the syringe and guide sleeve from the carrier</span></td> </tr> <tr> <td align="left"> <ul> <li>Remove the syringe and guide sleeve from the carrier by pulling back on the syringe (<a href="#IFUfig25">Figure 25</a>). The syringe will be locked into the guide sleeve.</li> <li>Properly dispose of the used syringe together with the needle and guide sleeve in a sharps disposal container or in accordance with local requirements.</li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig25"></a><img alt="Figure 25" src="/dailymed/image.cfm?name=susvimo-66.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 25</span> <br/>Remove the syringe and guide sleeve from the insertion tool carrier</p> </td> </tr> <tr> <td align="left" colspan="2"><span class="Bold">10. Slide the insertion tool handle into the carrier</span></td> </tr> <tr> <td align="left"> <ul> <li>Slide the insertion tool handle into the guide channel of the carrier, ensuring that both components are facing upwards (<a href="#IFUfig26">Figure 26</a>).</li> <li>Push the handle forward as far as it will go into the gripper tips (<a href="#IFUfig27">Figure 27</a>).</li> </ul> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-67.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/> <span class="Bold">Do not</span> withdraw the handle and implant until the eye is ready for insertion. Contact between the implant and any surface or object – even within the sterile field – may result in the introduction of a foreign body into the vitreous.</p> </td><td align="left"> <p class="First"> <a name="IFUfig26"></a><img alt="Figure 26" src="/dailymed/image.cfm?name=susvimo-68.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 26</span> <br/>Insert the handle into the insertion tool carrier<br/> <a name="IFUfig27"></a><img alt="Figure 27" src="/dailymed/image.cfm?name=susvimo-69.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 27</span> <br/>Fully inserted handle</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\">\n<p class=\"First\">\n<span class=\"Bold\">1.\tTransfer dose from vial to syringe</span>\n<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-48.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>Use the filter needle to withdraw ranibizumab from the vial.<br/>\n<span class=\"Bold\">Do not</span> use the initial fill needle for this step.</p>\n<ul>\n<li>Prepare ranibizumab vial by removing the flip-off cap and disinfecting the rubber vial septum with alcohol.</li>\n<li>Attach a filter needle to the syringe by screwing it tightly onto the Luer lock (<a href=\"#fig13a\">Figure 13</a>).</li>\n<li>Carefully remove the needle cap by pulling it straight off.</li>\n<li>Using aseptic technique, withdraw all of the contents of the ranibizumab vial through the filter needle into the syringe.</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"fig13a\"></a><img alt=\"Figure 13\" src=\"/dailymed/image.cfm?name=susvimo-49.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 13</span>\n<br/>Filter needle attached to syringe and cap removal</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">2.\tRemove air from syringe</span>\n<ul>\n<li>With the filter needle attached, hold the syringe with the needle pointing up.</li>\n<li>If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (<a href=\"#IFUfig14\">Figure 14</a>).</li>\n<li>Slowly push the plunger rod just until all air is expelled from the syringe and needle.<dl>\n<dt>–</dt>\n<dd>It is important to preserve as much drug as possible in order to completely fill the implant.</dd>\n</dl>\n</li>\n<li>Remove and properly dispose of the filter needle after air is removed from syringe.</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig14\"></a><img alt=\"Figure 14\" src=\"/dailymed/image.cfm?name=susvimo-48a.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 14</span>\n<br/>No air bubbles in syringe</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">3.\tAttach initial fill needle</span>\n<ul>\n<li>Attach the initial fill needle firmly onto the syringe by screwing it tightly onto the Luer lock (<a href=\"#IFUfig15a\">Figure 15</a>).</li>\n<li>Carefully remove the needle cap by pulling straight off.</li>\n</ul>\n<ul>\n<li>\n<span class=\"Bold\">Do not</span> wipe the needle at any time.</li>\n</ul>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-50.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>Ensure that the initial fill needle is attached to the syringe.<br/>\n<span class=\"Bold\">Do not</span> use the filter needle to fill the implant.</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig15a\"></a><img alt=\"Figure 15\" src=\"/dailymed/image.cfm?name=susvimo-51.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 15</span>\n<br/>Initial fill needle attached to syringe and cap removal</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">4.\tRemove any remaining air from syringe</span>\n<ul>\n<li>With the initial fill needle attached, hold the syringe with the needle pointing up.</li>\n<li>If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (<a href=\"#IFUfig16\">Figure 16</a>).</li>\n<li>Slowly push the plunger rod just until all air is expelled from the syringe and needle, and a drop of drug solution is seen at the needle tip (<a href=\"#IFUfig17\">Figure 17</a>).<dl>\n<dt>–</dt>\n<dd>It is important to preserve as much drug as possible in order to completely fill the implant.</dd>\n</dl>\n</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig16\"></a><img alt=\"Figure 16\" src=\"/dailymed/image.cfm?name=susvimo-52.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 16</span>\n<br/>Gently tap the syringe to dislodge bubbles<br/>\n<a name=\"IFUfig17\"></a><img alt=\"Figure 17\" src=\"/dailymed/image.cfm?name=susvimo-53.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 17</span>\n<br/>No air bubbles and a drop of drug at the needle tip</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">5.\tInspect the syringe for air bubbles</span>\n<ul>\n<li>Inspect the syringe and the needle hub to ensure that no air bubbles are present (<a href=\"#IFUfig18\">Figure 18</a>).</li>\n<li>If air bubbles are present, continue to remove air from the syringe and reinspect.</li>\n</ul>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-54.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>Use the syringe within <span class=\"Bold Underline\">15 minutes</span> of removing all air to avoid ranibizumab drying in the needle and impeding fluid flow.<br/>\n<span class=\"Bold\">Do not</span> use the initial fill needle if the needle is clogged.</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig18\"></a><img alt=\"Figure 18\" src=\"/dailymed/image.cfm?name=susvimo-55.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 18</span>\n<br/>No air bubbles in the syringe and needle hub</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\">\n<p class=\"First\">\n<span class=\"Bold\">6.\tLoad syringe into the carrier</span>\n<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-56.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>\n<span class=\"Bold\">Do not</span> hold or push on the plunger rod of the syringe while inserting the needle into the implant septum.</p>\n<ul>\n<li>Retrieve insertion tool carrier with pre-positioned implant from the inner tray.</li>\n<li>Align the syringe Luer lock above the Luer lock slot in the carrier to protect the needle from being damaged.</li>\n<li>Lower the syringe into the carrier (<a href=\"#IFUfig19\">Figure 19</a>).</li>\n<li>Push the syringe forward until it stops, taking care to avoid touching the plunger rod (<a href=\"#IFUfig20\">Figure 20</a>).</li>\n<li>With the syringe loaded, (<a href=\"#IFUfig21\">Figure 21</a>) the initial fill needle should now be penetrating the implant septum.</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig19\"></a><img alt=\"Figure 19\" src=\"/dailymed/image.cfm?name=susvimo-57.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 19</span>\n<br/>Align and lower the syringe into the carrier<br/>\n<a name=\"IFUfig20\"></a><img alt=\"Figure 20\" src=\"/dailymed/image.cfm?name=susvimo-58.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 20</span>\n<br/>Push the syringe into the carrier<br/>\n<a name=\"IFUfig21\"></a><img alt=\"Figure 21\" src=\"/dailymed/image.cfm?name=susvimo-59.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 21</span>\n<br/>Syringe with initial fill needle inserted through the implant septum</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">7.\tFill implant with ranibizumab under microscope</span>\n<ul>\n<li>Under the microscope, <span class=\"Bold Underline\">slowly</span> administer ranibizumab into the implant by slightly tilting the carrier upwards (<a href=\"#IFUfig22\">Figure 22</a>).</li>\n<li>The implant should be filled over approximately <span class=\"Bold Underline\">5 to 10 seconds</span>, to help avoid air entrapment in the implant reservoir.</li>\n<li>Continue filling the implant until the implant is completely full of drug solution and all air has been expelled as evidenced by a dome of drug solution formed at the tip of the implant on the release control element (<a href=\"#IFUfig23\">Figure 23</a>).<br/>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-60.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>When filling the implant, fluid should only exit the implant from the release control element. If fluid is leaking from the implant at a different location, such as the side of the implant, <span class=\"Bold\">do not</span> use the implant. <br/>If fluid is leaking from the septum at the needle insertion site, the needle may not be fully penetrating the implant septum. Fully push the syringe forward before continuing to fill the implant. </p>\n</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig22\"></a><img alt=\"Figure 22\" src=\"/dailymed/image.cfm?name=susvimo-61.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 22</span>\n<br/>Administer ranibizumab into the implant<br/>\n<a name=\"IFUfig23\"></a><img alt=\"Figure 23\" src=\"/dailymed/image.cfm?name=susvimo-62.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 23</span>\n<br/>Dome of drug solution forms at tip of implant as viewed under magnification</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">8.\tInspect the filled implant under the microscope</span>\n<ul>\n<li>\n<p class=\"First\">Inspect the implant under the microscope to ensure that the implant is completely full of drug solution (<a href=\"#IFUfig24\">Figure 24</a>).<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-63.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Warning</span>\n<br/>Minimize air bubbles within the implant reservoir as they may cause slower drug release. If an air bubble is present, it must be no larger than 1/3 of the widest diameter of the implant.<br/>If excess air is observed, <span class=\"Bold\">do not</span> use the implant.<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-64.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>No more than <span class=\"Bold Underline\">30 minutes</span> should pass between the initial fill of the implant and the insertion into the patient's eye to ensure that the release control element remains saturated with ranibizumab. If ranibizumab dries in the release control element, the implant may not release the drug properly into the vitreous after insertion.</p>\n</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig24\"></a><img alt=\"Figure 24\" src=\"/dailymed/image.cfm?name=susvimo-65.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 24</span>\n<br/>Proper appearance of implant after initial filling with ranibizumab</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"2\"><span class=\"Bold\">9.\tRemove the syringe and guide sleeve from the carrier</span></td>\n</tr>\n<tr>\n<td align=\"left\">\n<ul>\n<li>Remove the syringe and guide sleeve from the carrier by pulling back on the syringe (<a href=\"#IFUfig25\">Figure 25</a>). The syringe will be locked into the guide sleeve.</li>\n<li>Properly dispose of the used syringe together with the needle and guide sleeve in a sharps disposal container or in accordance with local requirements.</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig25\"></a><img alt=\"Figure 25\" src=\"/dailymed/image.cfm?name=susvimo-66.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 25</span>\n<br/>Remove the syringe and guide sleeve from the insertion tool carrier</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"2\"><span class=\"Bold\">10.\tSlide the insertion tool handle into the carrier</span></td>\n</tr>\n<tr>\n<td align=\"left\">\n<ul>\n<li>Slide the insertion tool handle into the guide channel of the carrier, ensuring that both components are facing upwards (<a href=\"#IFUfig26\">Figure 26</a>).</li>\n<li>Push the handle forward as far as it will go into the gripper tips (<a href=\"#IFUfig27\">Figure 27</a>).</li>\n</ul>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-67.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>\n<span class=\"Bold\">Do not</span> withdraw the handle and implant until the eye is ready for insertion. Contact between the implant and any surface or object – even within the sterile field – may result in the introduction of a foreign body into the vitreous.</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig26\"></a><img alt=\"Figure 26\" src=\"/dailymed/image.cfm?name=susvimo-68.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 26</span>\n<br/>Insert the handle into the insertion tool carrier<br/>\n<a name=\"IFUfig27\"></a><img alt=\"Figure 27\" src=\"/dailymed/image.cfm?name=susvimo-69.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 27</span>\n<br/>Fully inserted handle</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Implant Insertion

{ "type": "p", "children": [], "text": "Implant Insertion" }

1. Verify hemostasis of the scleral surface

{ "type": "p", "children": [], "text": "\n1.\tVerify hemostasis of the scleral surface\n" }

{ "type": "ul", "children": [ "Clear any excess blood from the scleral surface.", "Perform careful scleral wet field cauterization as needed, particularly in the area of the sclero-pars plana incision." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="left"><span class="Bold">2. Mark incision site</span> <ul> <li>Keep sclera dry and create discrete ink marks using a light touch.</li> <li>Mark a location <span class="Bold Underline">4 mm</span> from the limbus using an inked fixed width caliper (or equivalent) at the selected implant location (<a href="#IFUfig28">Figure 28</a>).</li> <li>Mark a <span class="Bold Underline">3.5 mm</span> length for scleral dissection parallel to and 4 mm posterior to the limbus using an inked fixed width caliper (or equivalent) (<a href="#IFUfig29">Figure 29</a>).</li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig28"></a><img alt="Figure 28" src="/dailymed/image.cfm?name=susvimo-70.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 28</span> <br/>4 mm posterior to the limbus<br/> <a name="IFUfig29"></a><img alt="Figure 29" src="/dailymed/image.cfm?name=susvimo-71.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 29</span> <br/>Fixed width caliper measurement</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"><span class=\"Bold\">2.\tMark incision site</span>\n<ul>\n<li>Keep sclera dry and create discrete ink marks using a light touch.</li>\n<li>Mark a location <span class=\"Bold Underline\">4 mm</span> from the limbus using an inked fixed width caliper (or equivalent) at the selected implant location (<a href=\"#IFUfig28\">Figure 28</a>).</li>\n<li>Mark a <span class=\"Bold Underline\">3.5 mm</span> length for scleral dissection parallel to and 4 mm posterior to the limbus using an inked fixed width caliper (or equivalent) (<a href=\"#IFUfig29\">Figure 29</a>).</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig28\"></a><img alt=\"Figure 28\" src=\"/dailymed/image.cfm?name=susvimo-70.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 28</span>\n<br/>4 mm posterior to the limbus<br/>\n<a name=\"IFUfig29\"></a><img alt=\"Figure 29\" src=\"/dailymed/image.cfm?name=susvimo-71.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 29</span>\n<br/>Fixed width caliper measurement</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="left"><span class="Bold">3. Perform scleral incision</span> <ul> <li>Using an MVR blade, create a full thickness dissection of the sclera until the pars plana is fully visible (<a href="#IFUfig30">Figure 30</a>).<dl> <dt>–</dt> <dd>Ensure scleral dissection location is away from the radial conjunctival incision.</dd> </dl> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-72.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>The final target length for the scleral incision is 3.5 mm. Keep in mind that laser may further result in enlargement of incision and limit the secureness of the fit of the implant.</p> <ul class="Disc"> <li>Confirm the length of the incision by using the largest width of the 3.5 mm incision gauge (<a href="#IFUfig31">Figure 31</a>).</li> <li>If the incision is over 3.5 mm, as indicated by a loose fit/side to side motion of 3.5 mm gauge, place a suture through the wound opposite the relaxing incision to reduce the incision down to 3.5 mm, and bury the knot. After suturing, confirm the incision length is 3.5 mm (<a href="#IFUfig31">Figure 31</a>).</li> <li>If there are any areas of visible bleeding from the wound, carefully perform diathermy.</li> </ul> </li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig30"></a><img alt="Figure30" src="/dailymed/image.cfm?name=susvimo-73.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 30</span> <br/>Stabilize the globe and perform full thickness scleral incision<br/> <a name="IFUfig31"></a><img alt="Figure 31" src="/dailymed/image.cfm?name=susvimo-74.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 31</span> <br/>Confirm correct length of scleral incision</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"><span class=\"Bold\">3.\tPerform scleral incision</span>\n<ul>\n<li>Using an MVR blade, create a full thickness dissection of the sclera until the pars plana is fully visible (<a href=\"#IFUfig30\">Figure 30</a>).<dl>\n<dt>–</dt>\n<dd>Ensure scleral dissection location is away from the radial conjunctival incision.</dd>\n</dl>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-72.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>The final target length for the scleral incision is 3.5 mm. Keep in mind that laser may further result in enlargement of incision and limit the secureness of the fit of the implant.</p>\n<ul class=\"Disc\">\n<li>Confirm the length of the incision by using the largest width of the 3.5 mm incision gauge (<a href=\"#IFUfig31\">Figure 31</a>).</li>\n<li>If the incision is over 3.5 mm, as indicated by a loose fit/side to side motion of 3.5 mm gauge, place a suture through the wound opposite the relaxing incision to reduce the incision down to 3.5 mm, and bury the knot. After suturing, confirm the incision length is 3.5 mm (<a href=\"#IFUfig31\">Figure 31</a>).</li>\n<li>If there are any areas of visible bleeding from the wound, carefully perform diathermy.</li>\n</ul>\n</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig30\"></a><img alt=\"Figure30\" src=\"/dailymed/image.cfm?name=susvimo-73.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 30</span>\n<br/>Stabilize the globe and perform full thickness scleral incision<br/>\n<a name=\"IFUfig31\"></a><img alt=\"Figure 31\" src=\"/dailymed/image.cfm?name=susvimo-74.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 31</span>\n<br/>Confirm correct length of scleral incision</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="left"><span class="Bold">4. Perform laser treatment of the pars plana</span> <br/> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-75.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>Laser treatment may result in enlargement of the incision. Laser treatment should not be used to intentionally enlarge the length of scleral incision.<br/> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-76.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>Carefully apply the laser only to the choroidal tissue in the exposed pars plana. Minimize any laser application to the surrounding scleral tissue to avoid damaging tissue integrity. </p> <ul> <li>Confirm pars plana is dry before laser treatment and keep dry throughout the procedure (with surgical sponge).<dl> <dt>–</dt> <dd>Consider placing a surgical sponge as a wick at one end of the incision.</dd> </dl> </li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig32"></a><img alt="Figure 32" src="/dailymed/image.cfm?name=susvimo-77.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 32</span> <br/>Laser treatment of the pars plana</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"><span class=\"Bold\">4.\tPerform laser treatment of the pars plana</span>\n<br/>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-75.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>Laser treatment may result in enlargement of the incision. Laser treatment should not be used to intentionally enlarge the length of scleral incision.<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-76.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>Carefully apply the laser only to the choroidal tissue in the exposed pars plana. Minimize any laser application to the surrounding scleral tissue to avoid damaging tissue integrity. \t\t\t\t\t\t\t\t\t\t</p>\n<ul>\n<li>Confirm pars plana is dry before laser treatment and keep dry throughout the procedure (with surgical sponge).<dl>\n<dt>–</dt>\n<dd>Consider placing a surgical sponge as a wick at one end of the incision.</dd>\n</dl>\n</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig32\"></a><img alt=\"Figure 32\" src=\"/dailymed/image.cfm?name=susvimo-77.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 32</span>\n<br/>Laser treatment of the pars plana</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

{ "type": "ul", "children": [ "Using a 532 nm laser endoprobe, apply contiguous, overlapping laser spots starting at 300 mW 1000 ms along the full length of the exposed pars plana (Figure 32). Repeat until complete ablation is achieved.\n–\nMaintain focus of laser on exposed pars plana.\n–\nKeep foot pedal depressed to achieve full 1000 ms spots (expect smoke).\n–\nEnsure the pars plana at the corners of scleral incision is adequately treated.\n–\n\nDo not use painting strokes with the laser.\n–\n\nDo not contact the pars plana directly with laser probe.\n\n", "Repeat application of laser along the full length of the pars plana until full or partial split of the pars plana, or other visual endpoints are achieved, as indicated by:\n–\nGray color change.\n–\nUniform perforated appearance.\n–\nDomes of vitreous fluid percolating through pars plana.\n\n", "If visual endpoint is not achieved after several passes with the laser, increase laser power in 100 mW increments.", "Once laser ablation of pars plana is completed, remeasure the entire length (including corners) of the scleral incision with 3.5 mm gauge to confirm the final post-laser incision is 3.5 mm. If final incision is greater than 3.5 mm, as indicated by a loose fit/side to side motion of 3.5 mm gauge, place a suture through the wound opposite the relaxing incision to reduce incision down to 3.5 mm." ], "text": "" }

Caution

{ "type": "p", "children": [], "text": "\nCaution\n" }

A final post-laser incision length of 3.5 mm provides a secure fit for the implant.

{ "type": "p", "children": [], "text": "A final post-laser incision length of 3.5 mm provides a secure fit for the implant." }

Do not enlarge the scleral dissection beyond 3.5 mm as a final incision length greater than 3.5 mm may result in an improperly seated implant and will require additional suturing.

{ "type": "p", "children": [], "text": "\nDo not enlarge the scleral dissection beyond 3.5 mm as a final incision length greater than 3.5 mm may result in an improperly seated implant and will require additional suturing." }

<div class="scrollingtable"><table class="Noautorules" width="80%"> <col align="left" valign="top" width="50%"/> <col align="left" valign="top" width="50%"/> <tbody class="Headless"> <tr> <td align="left"><span class="Bold">5. Perform pars plana incision</span> <ul> <li>Pass a 3.2 mm slit knife perpendicularly through the center of the scleral incision to open the underlying pars plana (<a href="#IFUfig33">Figure 33</a> and <a href="#IFUfig34">Figure 34</a>).</li> <li>Ensure widest part of the blade passes through the incision.</li> <li>Ensure adequate hemostasis.</li> <li>Carefully check for any active bleeding from the pars plana incision; if active bleeding is present, address it with fine tip diathermy within the incision before proceeding.</li> </ul> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-79.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/> <span class="Bold">Do not</span> enlarge the pars plana incision with lateral movements. The incision width of 3.2 mm ensures that the pars plana incision is within the laser-treated area of the pars plana and reduces the risk of vitreous hemorrhage.</p> <ul> <li>Aim to the center of the globe.</li> <li>Insert blade straight in and straight out.</li> <li>Avoid sideways motion.</li> <li>Avoid enlargement of the incision.</li> <li>Avoid the edges of the wound.</li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig33"></a><img alt="Figure 33" src="/dailymed/image.cfm?name=susvimo-80.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 33</span> <br/>Pars plana incision<br/> <a name="IFUfig34"></a><img alt="Figure 34" src="/dailymed/image.cfm?name=susvimo-81.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 34</span> <br/>Perpendicular entry of slit knife</p> </td> </tr> <tr> <td align="left" colspan="2"><span class="Bold">6. Withdraw the insertion tool handle with filled implant</span></td> </tr> <tr> <td align="left"> <ul> <li>Withdraw the insertion tool handle, which is now attached to the gripper tips and implant, by slowly pulling the carrier and handle apart (<a href="#IFUfig35">Figure 35</a>).</li> <li>Take care not to touch implant to any surface other than incision.</li> </ul> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-82.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>When holding the insertion tool handle, take care not to touch the implant to any surface other than the sclero-pars plana incision during the insertion procedure. <br/> <span class="Bold">Do not</span> use the implant if it is inadvertently released or is contaminated through contact with any surface other than the exposed sclera, including objects within the surgical field.</p> </td><td align="left"> <p class="First"> <a name="IFUfig35"></a><img alt="Figure 35" src="/dailymed/image.cfm?name=susvimo-83.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 35</span> <br/>Withdraw the insertion tool handle with filled implant</p> </td> </tr> <tr> <td align="left"><span class="Bold">7. Stabilize the globe</span> <ul> <li>Prior to inserting the implant, stabilize the globe with forceps to prevent unwanted eye movement (<a href="#IFUfig36">Figure 36</a>).</li> <li>The forceps should remain in place until the insertion procedure is complete.</li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig36"></a><img alt="Figure 36" src="/dailymed/image.cfm?name=susvimo-84.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 36</span> <br/>Stabilize the globe with forceps</p> </td> </tr> <tr> <td align="left"><span class="Bold">8. Orient the implant</span> <ul> <li>Orient the long axis of the implant flange with the length of the sclero-pars plana incision (<a href="#IFUfig37">Figure 37</a>).</li> <li>Aligning the implant in this direction enables the intended seating of the implant within the sclero-pars plana incision.</li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig37"></a><img alt="Figure 37" src="/dailymed/image.cfm?name=susvimo-85.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 37</span> <br/>The long axis of the implant aligned with the length of the sclero-pars plana incision</p> </td> </tr> <tr> <td align="left"> <p class="First"> <span class="Bold">9. Insert the implant</span> <br/> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-86.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Warning</span> <br/>Perpendicular entry of the implant is important to avoid contact between the implant and intraocular structures such as the lens, as contact between the implant and the intraocular structures may cause adverse events such as traumatic cataract.<br/> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-87.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Warning</span> <br/>Avoid excessive force on the globe by first ensuring that the tip of the implant has passed through the sclero-pars plana incision before slowly pushing the implant into place.</p> <ul> <li>Slowly insert the implant through the sclero-pars plana incision perpendicular to the globe (<a href="#IFUfig38">Figure 38</a> and <a href="#IFUfig39">Figure 39</a>).</li> <li>A slight initial twisting motion may be helpful to ease the implant through the sclero-pars plana incision (<a href="#IFUfig40">Figure 40</a>).</li> <li>Continue pressing the implant slowly through the incision until the insertion tool handle gripper tips abut the sclera.</li> <li>Per the surgeon's discretion, the infusion line may be turned on while inserting the implant.</li> <li>If excess vitreous prolapses from the incision, use the vitrector to remove it and then place the implant.</li> <li>If a small amount of vitreous prolapse is present, place the implant first and then use the vitrector to remove the excess. Only use the vitrector to remove vitreous prolapse (<span class="Bold">do not</span> use surgical sponge and/or scissors).</li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig38"></a><img alt="Figure 38" src="/dailymed/image.cfm?name=susvimo-88.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 38</span> <br/>Perpendicular entry of the implant<br/> <a name="IFUfig39"></a><img alt="Figure 39" src="/dailymed/image.cfm?name=susvimo-89.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 39</span> <br/>Implant insertion<br/> <a name="IFUfig40"></a><img alt="Figure 40" src="/dailymed/image.cfm?name=susvimo-90.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 40</span> <br/>Implant insertion with a slight initial twisting motion</p> </td> </tr> <tr> <td align="left"><span class="Bold">10. Release the implant</span> <ul> <li>Ensure that the long axis of the implant is properly aligned with the sclero-pars plana incision before releasing the implant from the insertion tool.</li> <li>The forceps that are stabilizing the globe should remain in place.</li> <li>Release the implant by depressing the release button completely (<a href="#IFUfig41">Figure 41</a> and <a href="#IFUfig42">Figure 42</a>).</li> </ul> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-91.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>If the implant flange is not parallel to the limbus after releasing, it needs to be repositioned solely using the gripper tips of the insertion tool handle. Reposition gently to avoid damage to the implant and to avoid contact between the implant and intraocular structures such as the lens. Avoid excessive manipulation of the implant flange.<br/> <span class="Bold">Do not</span> use any other rigid instruments to reposition.</p> </td><td align="left"> <p class="First"> <a name="IFUfig41"></a><img alt="Figure 41" src="/dailymed/image.cfm?name=susvimo-92.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 41</span> <br/>Release implant with the release button<br/> <a name="IFUfig42"></a><img alt="Figure 42" src="/dailymed/image.cfm?name=susvimo-93.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 42</span> <br/>Implant release</p> </td> </tr> <tr> <td align="left"> <p class="First"> <span class="Bold">11. Seat the implant</span> <br/> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-94.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>Use the insertion tool gripper tips to seat the implant.<br/> <span class="Bold">Do not</span> use any other rigid instruments as they may damage the implant.<br/> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-95.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>Ensure that the long axis of the implant is aligned with the length of the sclero-pars plana incision and that the implant is seated flush against the sclera.</p> <ul> <li>Remove finger from the release button to close the insertion tool gripper tips.</li> <li>Gently press the closed gripper tips against the <span class="Bold Underline">center</span> of the implant to seat the implant flush against the sclera (<a href="#IFUfig43">Figure 43</a>).</li> <li>Clean any residual vitreous around the implant flange using a vitrector.</li> </ul> </td><td align="left"> <p class="First"> <a name="IFUfig43"></a><img alt="Figure 43" src="/dailymed/image.cfm?name=susvimo-96.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 43</span> <br/>Seat the implant</p> </td> </tr> <tr> <td align="left"><span class="Bold">12. Suture Tenon's capsule and conjunctiva</span> <br/> <ul> <li>Close both Tenon's capsule and conjunctiva, with Vicryl or gut sutures, ensuring complete coverage of the implant flange.</li> <li>Use scleral anchoring at the apex of the peritomy.</li> <li>Ensure suture placement away from the implant (<a href="#IFUfig44">Figure 44</a>).</li> </ul> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-97.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/> <span class="Bold">Do not</span> place a suture directly over the implant, otherwise adverse events including incomplete healing, infection, and discomfort can occur.<br/> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-98.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><span class="Bold">Caution</span> <br/>Complete closure of both Tenon's capsule and conjunctiva across the surgical site is critical to minimize potential complications such as conjunctival retraction over the implant.</p> </td><td align="left"> <p class="First"> <a name="IFUfig44"></a><img alt="Figure 44" src="/dailymed/image.cfm?name=susvimo-99.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/><br/> <span class="Bold">Figure 44</span> <br/>Suture conjunctiva</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"80%\">\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<col align=\"left\" valign=\"top\" width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\"><span class=\"Bold\">5.\tPerform pars plana incision</span>\n<ul>\n<li>Pass a 3.2 mm slit knife perpendicularly through the center of the scleral incision to open the underlying pars plana (<a href=\"#IFUfig33\">Figure 33</a> and <a href=\"#IFUfig34\">Figure 34</a>).</li>\n<li>Ensure widest part of the blade passes through the incision.</li>\n<li>Ensure adequate hemostasis.</li>\n<li>Carefully check for any active bleeding from the pars plana incision; if active bleeding is present, address it with fine tip diathermy within the incision before proceeding.</li>\n</ul>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-79.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>\n<span class=\"Bold\">Do not</span> enlarge the pars plana incision with lateral movements. The incision width of 3.2 mm ensures that the pars plana incision is within the laser-treated area of the pars plana and reduces the risk of vitreous hemorrhage.</p>\n<ul>\n<li>Aim to the center of the globe.</li>\n<li>Insert blade straight in and straight out.</li>\n<li>Avoid sideways motion.</li>\n<li>Avoid enlargement of the incision.</li>\n<li>Avoid the edges of the wound.</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig33\"></a><img alt=\"Figure 33\" src=\"/dailymed/image.cfm?name=susvimo-80.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 33</span>\n<br/>Pars plana incision<br/>\n<a name=\"IFUfig34\"></a><img alt=\"Figure 34\" src=\"/dailymed/image.cfm?name=susvimo-81.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 34</span>\n<br/>Perpendicular entry of slit knife</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" colspan=\"2\"><span class=\"Bold\">6.\tWithdraw the insertion tool handle with filled implant</span></td>\n</tr>\n<tr>\n<td align=\"left\">\n<ul>\n<li>Withdraw the insertion tool handle, which is now attached to the gripper tips and implant, by slowly pulling the carrier and handle apart (<a href=\"#IFUfig35\">Figure 35</a>).</li>\n<li>Take care not to touch implant to any surface other than incision.</li>\n</ul>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-82.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>When holding the insertion tool handle, take care not to touch the implant to any surface other than the sclero-pars plana incision during the insertion procedure. <br/>\n<span class=\"Bold\">Do not</span> use the implant if it is inadvertently released or is contaminated through contact with any surface other than the exposed sclera, including objects within the surgical field.</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig35\"></a><img alt=\"Figure 35\" src=\"/dailymed/image.cfm?name=susvimo-83.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 35</span>\n<br/>Withdraw the insertion tool handle with filled implant</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">7.\tStabilize the globe</span>\n<ul>\n<li>Prior to inserting the implant, stabilize the globe with forceps to prevent unwanted eye movement (<a href=\"#IFUfig36\">Figure 36</a>).</li>\n<li>The forceps should remain in place until the insertion procedure is complete.</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig36\"></a><img alt=\"Figure 36\" src=\"/dailymed/image.cfm?name=susvimo-84.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 36</span>\n<br/>Stabilize the globe with forceps</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">8.\tOrient the implant</span>\n<ul>\n<li>Orient the long axis of the implant flange with the length of the sclero-pars plana incision (<a href=\"#IFUfig37\">Figure 37</a>).</li>\n<li>Aligning the implant in this direction enables the intended seating of the implant within the sclero-pars plana incision.</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig37\"></a><img alt=\"Figure 37\" src=\"/dailymed/image.cfm?name=susvimo-85.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 37</span>\n<br/>The long axis of the implant aligned with the length of the sclero-pars plana incision</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\">\n<p class=\"First\">\n<span class=\"Bold\">9.\tInsert the implant</span>\n<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-86.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Warning</span>\n<br/>Perpendicular entry of the implant is important to avoid contact between the implant and intraocular structures such as the lens, as contact between the implant and the intraocular structures may cause adverse events such as traumatic cataract.<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-87.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Warning</span>\n<br/>Avoid excessive force on the globe by first ensuring that the tip of the implant has passed through the sclero-pars plana incision before slowly pushing the implant into place.</p>\n<ul>\n<li>Slowly insert the implant through the sclero-pars plana incision perpendicular to the globe (<a href=\"#IFUfig38\">Figure 38</a> and <a href=\"#IFUfig39\">Figure 39</a>).</li>\n<li>A slight initial twisting motion may be helpful to ease the implant through the sclero-pars plana incision (<a href=\"#IFUfig40\">Figure 40</a>).</li>\n<li>Continue pressing the implant slowly through the incision until the insertion tool handle gripper tips abut the sclera.</li>\n<li>Per the surgeon's discretion, the infusion line may be turned on while inserting the implant.</li>\n<li>If excess vitreous prolapses from the incision, use the vitrector to remove it and then place the implant.</li>\n<li>If a small amount of vitreous prolapse is present, place the implant first and then use the vitrector to remove the excess. Only use the vitrector to remove vitreous prolapse (<span class=\"Bold\">do not</span> use surgical sponge and/or scissors).</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig38\"></a><img alt=\"Figure 38\" src=\"/dailymed/image.cfm?name=susvimo-88.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 38</span>\n<br/>Perpendicular entry of the implant<br/>\n<a name=\"IFUfig39\"></a><img alt=\"Figure 39\" src=\"/dailymed/image.cfm?name=susvimo-89.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 39</span>\n<br/>Implant insertion<br/>\n<a name=\"IFUfig40\"></a><img alt=\"Figure 40\" src=\"/dailymed/image.cfm?name=susvimo-90.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 40</span>\n<br/>Implant insertion with a slight initial twisting motion</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">10.\tRelease the implant</span>\n<ul>\n<li>Ensure that the long axis of the implant is properly aligned with the sclero-pars plana incision before releasing the implant from the insertion tool.</li>\n<li>The forceps that are stabilizing the globe should remain in place.</li>\n<li>Release the implant by depressing the release button completely (<a href=\"#IFUfig41\">Figure 41</a> and <a href=\"#IFUfig42\">Figure 42</a>).</li>\n</ul>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-91.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>If the implant flange is not parallel to the limbus after releasing, it needs to be repositioned solely using the gripper tips of the insertion tool handle. Reposition gently to avoid damage to the implant and to avoid contact between the implant and intraocular structures such as the lens. Avoid excessive manipulation of the implant flange.<br/>\n<span class=\"Bold\">Do not</span> use any other rigid instruments to reposition.</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig41\"></a><img alt=\"Figure 41\" src=\"/dailymed/image.cfm?name=susvimo-92.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 41</span>\n<br/>Release implant with the release button<br/>\n<a name=\"IFUfig42\"></a><img alt=\"Figure 42\" src=\"/dailymed/image.cfm?name=susvimo-93.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 42</span>\n<br/>Implant release</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\">\n<p class=\"First\">\n<span class=\"Bold\">11.\tSeat the implant</span>\n<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-94.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>Use the insertion tool gripper tips to seat the implant.<br/>\n<span class=\"Bold\">Do not</span> use any other rigid instruments as they may damage the implant.<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-95.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>Ensure that the long axis of the implant is aligned with the length of the sclero-pars plana incision and that the implant is seated flush against the sclera.</p>\n<ul>\n<li>Remove finger from the release button to close the insertion tool gripper tips.</li>\n<li>Gently press the closed gripper tips against the <span class=\"Bold Underline\">center</span> of the implant to seat the implant flush against the sclera (<a href=\"#IFUfig43\">Figure 43</a>).</li>\n<li>Clean any residual vitreous around the implant flange using a vitrector.</li>\n</ul>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig43\"></a><img alt=\"Figure 43\" src=\"/dailymed/image.cfm?name=susvimo-96.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 43</span>\n<br/>Seat the implant</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\"><span class=\"Bold\">12.\tSuture Tenon's capsule and conjunctiva</span>\n<br/>\n<ul>\n<li>Close both Tenon's capsule and conjunctiva, with Vicryl or gut sutures, ensuring complete coverage of the implant flange.</li>\n<li>Use scleral anchoring at the apex of the peritomy.</li>\n<li>Ensure suture placement away from the implant (<a href=\"#IFUfig44\">Figure 44</a>).</li>\n</ul>\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-97.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>\n<span class=\"Bold\">Do not</span> place a suture directly over the implant, otherwise adverse events including incomplete healing, infection, and discomfort can occur.<br/>\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-98.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><span class=\"Bold\">Caution</span>\n<br/>Complete closure of both Tenon's capsule and conjunctiva across the surgical site is critical to minimize potential complications such as conjunctival retraction over the implant.</p>\n</td><td align=\"left\">\n<p class=\"First\">\n<a name=\"IFUfig44\"></a><img alt=\"Figure 44\" src=\"/dailymed/image.cfm?name=susvimo-99.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/><br/>\n<span class=\"Bold\">Figure 44</span>\n<br/>Suture conjunctiva</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

13. Remove infusion cannula

{ "type": "p", "children": [], "text": "\n13.\tRemove infusion cannula\n" }

{ "type": "ul", "children": [ "If the infusion was previously turned on, then set the infusion pressure to 20 mmHg before removing the infusion cannula.", "Check for persistent leaks at the infusion cannula site and suture if necessary." ], "text": "" }

14. Check Intraocular Pressure (IOP)

{ "type": "p", "children": [], "text": "\n14.\tCheck Intraocular Pressure (IOP)\n" }

{ "type": "ul", "children": [ "Using digital palpation, check the IOP. If necessary, inject additional fluid to restore IOP." ], "text": "" }

15. Check implant placement

{ "type": "p", "children": [], "text": "\n15.\tCheck implant placement\n" }

{ "type": "ul", "children": [ "Perform indirect ophthalmoscopy to confirm implant position and to examine for the presence of any complications." ], "text": "" }

Disposal and Post-insertion Procedures

{ "type": "p", "children": [], "text": "\t\t\t\t\t\t\tDisposal and Post-insertion Procedures \t\t\t\t\t\t" }

1. Dispose of used Susvimo components and tools

{ "type": "p", "children": [], "text": "\n1.\tDispose of used Susvimo components and tools\n" }

{ "type": "ul", "children": [ "\nDo not recap the needle or detach it from the syringe. Dispose of the used Susvimo components and tools in a sharps disposal container or in accordance with local requirements." ], "text": "" }

2. Perform post-insertion procedures

{ "type": "p", "children": [], "text": "\n2.\tPerform post-insertion procedures\n" }

{ "type": "ul", "children": [ "Post-insertion procedures are consistent with standard post-surgical procedures." ], "text": "" }

3. Post-insertion patient instructions

{ "type": "p", "children": [], "text": "\n3.\tPost-insertion patient instructions\n" }

Provide the patient with the following post-operative instructions:

{ "type": "p", "children": [], "text": "Provide the patient with the following post-operative instructions:" }

{ "type": "ul", "children": [ "Positioning:\n–\nKeep head above shoulder level for the rest of the day.\n–\nSleep with head elevated on 3 or more pillows if lying down during the day and night after implant insertion.\n\n", "Information on caring for the eye after the procedure, including but not limited to the following:\n–\n\nDo not remove the eye shield until they are instructed to do so by their physician. At bedtime, continue to wear the eye shield for at least 7 nights following implant insertion.\n–\nAdminister all post-operative eye medications, as directed by their physician.\n–\n\nDo not push on the eye, rub the eye, or touch the region of the eye where the implant is located (underneath the eyelid in the upper and outer part of the eye) for 30 days following implant insertion. Avoid rubbing the eye or touching the area where the implant is located as much as possible at all other times but if necessary to do so, make sure hands are cleaned prior to touching the eye.\n–\n\nDo not participate in strenuous activities until 1 month after implant insertion or after discussion with their physician.\n\n", "Monitor for symptoms that may require immediate medical attention while the implant is in place.", "MR Conditional information:\n–\nThe surgeon should inform the patient that the implant is MR Conditional (as noted on their Susvimo implant card) and if patient needs to undergo an MRI, they should let their doctor know they have Susvimo implanted in their eye.\n–\nAfter implant insertion, the surgeon should give the patient the implant card (enclosed in this IFU on the last page) with the appropriate information filled in, and should advise the patient to keep the card in a safe place, e.g. his or her wallet, for future reference. The surgeon should advise the patient that this implant card contains important information related to the Susvimo implant and that the card should be shown to their current and future health care providers.\n\n" ], "text": "" }

Explanation of symbols on product or package labeling

{ "type": "p", "children": [], "text": "Explanation of symbols on product or package labeling" }

<div class="scrollingtable"><table width="50%"> <caption> <span>Table 6 Symbols on blister tray and carton</span> </caption> <col align="center" valign="middle" width="20%"/> <col align="left" valign="middle" width="80%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Symbol</th><th align="left" class="Rrule">Title</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-100.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Manufacturer</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-101.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Prescription only</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-102.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Do not re-use</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-103.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Do not use if package is damaged</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-104.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Consult Instructions for Use</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-105.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Sterilized by irradiation</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-106.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Sterilized using ethylene oxide</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-107.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Temperature limit</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-108.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Expiration date/Use by date</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-109.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Lot/Batch number</td> </tr> <tr class="Botrule Last"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-110.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">MR Conditional</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"50%\">\n<caption>\n<span>Table 6 Symbols on blister tray and carton</span>\n</caption>\n<col align=\"center\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"80%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Lrule Rrule\">Symbol</th><th align=\"left\" class=\"Rrule\">Title</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-100.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Manufacturer</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-101.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Prescription only</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-102.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Do not re-use</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-103.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Do not use if package is damaged</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-104.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Consult Instructions for Use</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-105.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Sterilized by irradiation</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-106.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Sterilized using ethylene oxide</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-107.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Temperature limit</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-108.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Expiration date/Use by date</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-109.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Lot/Batch number</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-110.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">MR Conditional</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="55%"> <col align="left" valign="middle" width="100%"/> <tfoot> <tr> <td align="left" valign="top"><span class="Italics">Note - The Implant LOT number can be found on the carton and blister tray of the Susvimo™ Insertion Tool Assembly</span></td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="left"> <p class="First"> <img alt="Image" src="/dailymed/image.cfm?name=susvimo-112.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"55%\">\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<tfoot>\n<tr>\n<td align=\"left\" valign=\"top\"><span class=\"Italics\">Note - The Implant LOT number can be found on the carton and blister tray of the Susvimo™ Insertion Tool Assembly</span></td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\">\n<p class=\"First\">\n<img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-112.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Manufactured by:

{ "type": "p", "children": [], "text": "Manufactured by:" }

Genentech, Inc. A Member of the Roche Group1 DNA WaySouth San Francisco, CA 94080-4990U.S. License No.: 1048

{ "type": "p", "children": [], "text": "\nGenentech, Inc.\nA Member of the Roche Group1 DNA WaySouth San Francisco, CA 94080-4990U.S. License No.: 1048" }

SUSVIMO is a trademark of Genentech, Inc. ©2021 Genentech, Inc. All rights reserved.

{ "type": "p", "children": [], "text": "SUSVIMO is a trademark of Genentech, Inc. ©2021 Genentech, Inc. All rights reserved." }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.Approved: 4/2022

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug Administration.Approved: 4/2022" }

Susvimo™ (ranibizumab injection)For Susvimo ocular implant useInstructions for Use

{ "type": "p", "children": [], "text": "\nSusvimo™\n(ranibizumab injection)For Susvimo ocular implant useInstructions for Use" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="left" valign="top" width="100%"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Toprule"><span class="Bold">Implant Removal Procedure</span></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"left\" valign=\"top\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Toprule\"><span class=\"Bold\">Implant Removal Procedure</span></td>\n</tr>\n</tbody>\n</table></div>" }

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

{ "type": "p", "children": [], "text": "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." }

Susvimo procedures should be performed by an ophthalmologist experienced in vitreoretinal surgery.

{ "type": "p", "children": [], "text": "Susvimo procedures should be performed by an ophthalmologist experienced in vitreoretinal surgery." }

Refer to the Susvimo (ranibizumab injection) 100 mg/mL prescribing information for a complete list of indications, contraindications, warnings, precautions, and adverse events.

{ "type": "p", "children": [], "text": "Refer to the Susvimo (ranibizumab injection) 100 mg/mL prescribing information for a complete list of indications, contraindications, warnings, precautions, and adverse events." }

Contents

{ "type": "p", "children": [], "text": "\tContents " }

Introduction

{ "type": "p", "children": [], "text": "\nIntroduction\n" }

<div class="scrollingtable"><table class="Noautorules" width="60%"> <col align="left" valign="middle" width="6%"/> <col align="left" valign="middle" width="94%"/> <tbody class="Headless"> <tr> <td align="left">3</td><td align="left">Device Description</td> </tr> <tr> <td align="left">3</td><td align="left">Components</td> </tr> <tr> <td align="left">4</td><td align="left">Intended Use/ Indications for Use</td> </tr> <tr> <td align="left">4</td><td align="left">Warnings</td> </tr> <tr> <td align="left">4</td><td align="left">Precautions</td> </tr> <tr> <td align="left">5</td><td align="left">How Supplied, Handling, and Storage</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"60%\">\n<col align=\"left\" valign=\"middle\" width=\"6%\"/>\n<col align=\"left\" valign=\"middle\" width=\"94%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\">3</td><td align=\"left\">Device Description</td>\n</tr>\n<tr>\n<td align=\"left\">3</td><td align=\"left\">Components</td>\n</tr>\n<tr>\n<td align=\"left\">4</td><td align=\"left\">Intended Use/ Indications for Use</td>\n</tr>\n<tr>\n<td align=\"left\">4</td><td align=\"left\">Warnings</td>\n</tr>\n<tr>\n<td align=\"left\">4</td><td align=\"left\">Precautions</td>\n</tr>\n<tr>\n<td align=\"left\">5</td><td align=\"left\">How Supplied, Handling, and Storage</td>\n</tr>\n</tbody>\n</table></div>" }

Instructions for Use

{ "type": "p", "children": [], "text": "\nInstructions for Use\n" }

<div class="scrollingtable"><table class="Noautorules" width="60%"> <col align="left" valign="middle" width="6%"/> <col align="left" valign="middle" width="94%"/> <tbody class="Headless"> <tr> <td align="left">6</td><td align="left">Introduction and Materials</td> </tr> <tr> <td align="left">7</td><td align="left">Preparatory Procedures</td> </tr> <tr> <td align="left">8</td><td align="left">Implant Removal </td> </tr> <tr> <td align="left">16</td><td align="left">Disposal and Post-removal Procedures</td> </tr> <tr> <td align="left">17</td><td align="left">Explanation of symbols on product or package labeling</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"60%\">\n<col align=\"left\" valign=\"middle\" width=\"6%\"/>\n<col align=\"left\" valign=\"middle\" width=\"94%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\">6</td><td align=\"left\">Introduction and Materials</td>\n</tr>\n<tr>\n<td align=\"left\">7</td><td align=\"left\">Preparatory Procedures</td>\n</tr>\n<tr>\n<td align=\"left\">8</td><td align=\"left\">Implant Removal </td>\n</tr>\n<tr>\n<td align=\"left\">16</td><td align=\"left\">Disposal and Post-removal Procedures</td>\n</tr>\n<tr>\n<td align=\"left\">17</td><td align=\"left\">Explanation of symbols on product or package labeling</td>\n</tr>\n</tbody>\n</table></div>" }

Introduction

{ "type": "p", "children": [], "text": "\nIntroduction\n" }

These instructions include only the implant removal procedure for the Susvimo implant. Refer to the Susvimo Instructions for Use for the initial fill and implant procedure and prescribing information for the refill-exchange procedure.

{ "type": "p", "children": [], "text": "These instructions include only the implant removal procedure for the Susvimo implant. Refer to the Susvimo Instructions for Use for the initial fill and implant procedure and prescribing information for the refill-exchange procedure." }

Device Description

{ "type": "p", "children": [], "text": "Device Description" }

Susvimo is an intraocular drug delivery system designed to be used specifically with Susvimo (ranibizumab injection) 100 mg/mL.

{ "type": "p", "children": [], "text": "Susvimo is an intraocular drug delivery system designed to be used specifically with Susvimo (ranibizumab injection) 100 mg/mL." }

These Instructions for Use describe the required materials and steps necessary for removal of the Susvimo implant.

{ "type": "p", "children": [], "text": "These Instructions for Use describe the required materials and steps necessary for removal of the Susvimo implant." }

Components

{ "type": "p", "children": [], "text": "Components" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><a name="fig1b"></a><img alt="Figure 1" src="/dailymed/image.cfm?name=susvimo-113.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td> </tr> <tr> <td align="center"><span class="Bold">Figure 1</span> <br/>Susvimo components for implant removal procedure</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><a name=\"fig1b\"></a><img alt=\"Figure 1\" src=\"/dailymed/image.cfm?name=susvimo-113.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">Figure 1</span>\n<br/>Susvimo components for implant removal procedure</td>\n</tr>\n</tbody>\n</table></div>" }

Susvimo explant tool

{ "type": "p", "children": [], "text": "\nSusvimo explant tool\n" }

Susvimo explant tool (Figure 2) is a pair of forceps with contoured tips, which are designed to grasp underneath the implant flange to securely engage the implant during removal.

{ "type": "p", "children": [], "text": "Susvimo explant tool (Figure 2) is a pair of forceps with contoured tips, which are designed to grasp underneath the implant flange to securely engage the implant during removal." }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><a name="fig2b"></a><img alt="Figure 2" src="/dailymed/image.cfm?name=susvimo-114.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td> </tr> <tr> <td align="center"><span class="Bold">Figure 2</span> <br/>Susvimo explant tool</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><a name=\"fig2b\"></a><img alt=\"Figure 2\" src=\"/dailymed/image.cfm?name=susvimo-114.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">Figure 2</span>\n<br/>Susvimo explant tool</td>\n</tr>\n</tbody>\n</table></div>" }

Intended Use/ Indications for Use

{ "type": "p", "children": [], "text": "Intended Use/ Indications for Use" }

Susvimo explant tool is approved for use with Susvimo ocular implant. Refer to the Susvimo (ranibizumab injection) prescribing information for a complete list of indications, contraindications, warnings, precautions, and adverse events.

{ "type": "p", "children": [], "text": "Susvimo explant tool is approved for use with Susvimo ocular implant. Refer to the Susvimo (ranibizumab injection) prescribing information for a complete list of indications, contraindications, warnings, precautions, and adverse events." }

Warnings

{ "type": "p", "children": [], "text": "Warnings" }

{ "type": "ul", "children": [ "\nDo not use if the sterility has been compromised or the contents have been dropped, damaged or tampered with.", "\nDo not grasp the implant by the short axis of the implant flange. Remove the implant in a gentle manner. Perpendicular exit of the implant is important to avoid contact between the implant and intraocular structures such as the lens." ], "text": "" }

Precautions

{ "type": "p", "children": [], "text": "Precautions" }

{ "type": "ul", "children": [ "Read and follow all instructions, warnings, and cautions prior to use.", "Susvimo procedures should be performed by an ophthalmologist experienced in vitreoretinal surgery. ", "Use Susvimo components and materials as specified in these instructions to perform the implant removal procedure." ], "text": "" }

How Supplied, Handling, and Storage

{ "type": "p", "children": [], "text": "How Supplied, Handling, and Storage" }

{ "type": "ul", "children": [ "Susvimo explant tool has been electron beam sterilized. Do not reprocess or resterilize.", "Susvimo explant tool is for single-use only. Do not reuse the Susvimo explant tool.", "\nDo not open sealed tray until time of use.", "\nDo not use if the package is damaged or broken as sterility may be compromised.", "\nDo not use past the expiration date printed on the label.", "Susvimo explant tool should be stored at a room temperature 15°C to 25°C (59°F to 77°F)." ], "text": "" }

Instructions for Use

{ "type": "p", "children": [], "text": "\nInstructions for Use\n" }

Introduction and Materials

{ "type": "p", "children": [], "text": "Introduction and Materials" }

Removal of the Susvimo implant requires a surgical procedure that is performed in an operating room.

{ "type": "p", "children": [], "text": "Removal of the Susvimo implant requires a surgical procedure that is performed in an operating room." }

Materials List

{ "type": "p", "children": [], "text": "\nMaterials List\n" }

Materials that are required and provided for the procedure are listed in Table 1.

{ "type": "p", "children": [], "text": "Materials that are required and provided for the procedure are listed in Table 1." }

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 1 Susvimo sterile components that are provided for implant removal</span> </caption> <col align="left" valign="middle" width="100%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Item Description</th> </tr> </thead> <tbody> <tr class="First Last"> <td align="left" class="Lrule Rrule">Susvimo explant tool</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<caption>\n<span>Table 1\tSusvimo sterile components that are provided for implant removal</span>\n</caption>\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Lrule Rrule\">Item Description</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First Last\">\n<td align=\"left\" class=\"Lrule Rrule\">Susvimo explant tool</td>\n</tr>\n</tbody>\n</table></div>" }

Materials required but not provided are listed in Table 2.

{ "type": "p", "children": [], "text": "Materials required but not provided are listed in Table 2." }

<div class="scrollingtable"><table width="75%"> <caption> <span>Table 2 Additional materials required but not provided for implant removal</span> </caption> <col align="left" valign="middle" width="100%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Item Description</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="left" class="Lrule Rrule">Surgical microscope</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Vitrectomy surgical control system</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Standard 25 G or 27 G vitrectomy set up</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Standard vitrectomy tray <span class="Italics">(including 0.12 straight toothed forceps and blunt wescott scissors)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Cauterization equipment <span class="Italics">(including standard fine tip diathermy and eraser tip wet-field cautery)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Ophthalmic broad-spectrum microbicide solution</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Surgical scalpel blade #15</td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Non-absorbable sutures for sclera <span class="Italics">(suggested Nylon)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Gut or Vicryl sutures for conjunctival tissues <span class="Italics">(suggested 7-0 to 9-0: monofilament recommended)</span></td> </tr> <tr class="Botrule"> <td align="left" class="Lrule Rrule">Indirect ophthalmoscope and lens</td> </tr> <tr class="Botrule Last"> <td align="left" class="Lrule Rrule">Drapes</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<caption>\n<span>Table 2\tAdditional materials required but not provided for implant removal</span>\n</caption>\n<col align=\"left\" valign=\"middle\" width=\"100%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Lrule Rrule\">Item Description</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"left\" class=\"Lrule Rrule\">Surgical microscope</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Vitrectomy surgical control system</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Standard 25 G or 27 G vitrectomy set up</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Standard vitrectomy tray <span class=\"Italics\">(including 0.12 straight toothed forceps and blunt wescott scissors)</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Cauterization equipment <span class=\"Italics\">(including standard fine tip diathermy and eraser tip wet-field cautery)</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Ophthalmic broad-spectrum microbicide solution</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Surgical scalpel blade #15</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Non-absorbable sutures for sclera <span class=\"Italics\">(suggested Nylon)</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Gut or Vicryl sutures for conjunctival tissues <span class=\"Italics\">(suggested 7-0 to 9-0: monofilament recommended)</span></td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"left\" class=\"Lrule Rrule\">Indirect ophthalmoscope and lens</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"left\" class=\"Lrule Rrule\">Drapes</td>\n</tr>\n</tbody>\n</table></div>" }

Preparatory Procedures

{ "type": "p", "children": [], "text": "Preparatory Procedures" }

1. Inspect and open sterile packaging

{ "type": "p", "children": [], "text": "\n1.\tInspect and open sterile packaging\n" }

{ "type": "ul", "children": [ "Prior to use in the operating room, inspect the sterile packaging of the explant tool for damage.", "Check the expiration date printed on the label.", "Open sterile packaging and using aseptic technique, remove the explant tool from the tray.", "Inspect the explant tool and place onto sterile surface." ], "text": "" }

Warning

{ "type": "p", "children": [], "text": "\nWarning\n" }

Do not use if the sterility has been compromised or the contents have been dropped, damaged, or tampered with.

{ "type": "p", "children": [], "text": "\nDo not use if the sterility has been compromised or the contents have been dropped, damaged, or tampered with." }

2. Patient Preparation

{ "type": "p", "children": [], "text": "\n2.\tPatient Preparation\n" }

{ "type": "ul", "children": [ "Dilate the pupil of the eye.", "Place the patient in a supine position on the operating table.", "Implant removal is a surgical procedure and therefore requires sterile controls (i.e. use of ophthalmic broad-spectrum microbicide solution on eye including lids and lashes and draping) be in place to minimize the risk of ocular infection.", "Perform the procedure under local anesthesia using either peribulbar, retrobulbar, or sub-Tenon's technique. ", "Place lid speculum. " ], "text": "" }

Implant Removal

{ "type": "p", "children": [], "text": "Implant Removal" }

Perform the implant removal procedure under the microscope. Consider placing a traction suture for better visualization of the superotemporal quadrant throughout the entire implant removal procedure.

{ "type": "p", "children": [], "text": "Perform the implant removal procedure under the microscope. Consider placing a traction suture for better visualization of the superotemporal quadrant throughout the entire implant removal procedure." }

1. Place infusion line

{ "type": "p", "children": [], "text": "\n1.\tPlace infusion line\n" }

{ "type": "ul", "children": [ "Place an infusion cannula in the inferotemporal quadrant via an angled entry wound.", "Attach the infusion line, however keep the infusion off." ], "text": "" }

2. Perform conjunctival peritomy

{ "type": "p", "children": [], "text": "\n2.\tPerform conjunctival peritomy\n" }

{ "type": "ul", "children": [ "Create at least a 6 mm by 6 mm peritomy of the conjunctiva and Tenon's capsule around the implant flange (Figure 3)." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><a name="fig3b"></a><img alt="Figure 3" src="/dailymed/image.cfm?name=susvimo-116.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td> </tr> <tr> <td align="center"><span class="Bold">Figure 3</span> <br/>Conjunctival peritomy</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><a name=\"fig3b\"></a><img alt=\"Figure 3\" src=\"/dailymed/image.cfm?name=susvimo-116.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">Figure 3</span>\n<br/>Conjunctival peritomy</td>\n</tr>\n</tbody>\n</table></div>" }

3. Remove fibrous capsule covering implant

{ "type": "p", "children": [], "text": "\n3.\tRemove fibrous capsule covering implant\n" }

{ "type": "ul", "children": [ "Remove any fibrous capsule or scar tissue that may have formed over the implant flange and septum (Figure 4 and Figure 5).\n–\nTo expose the implant, use a scalpel to make an incision in the tissue around the entire circumference of the implant (Figure 4).\n–\nUse forceps to carefully dissect the implant flange and neck from the surrounding tissue so that the edges of the flange are completely exposed and the implant is free of any adherent tissue (Figure 5).\n\n" ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><a name="fig4b"></a><img alt="Figure 4" src="/dailymed/image.cfm?name=susvimo-117.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td> </tr> <tr> <td align="center"><span class="Bold">Figure 4</span> <br/>Incision to remove tissue that may be covering the implant flange and septum</td> </tr> <tr> <td align="center"><a name="fig5b"></a><img alt="Figure 5" src="/dailymed/image.cfm?name=susvimo-118.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td> </tr> <tr> <td align="center"><span class="Bold">Figure 5</span> <br/>Exposed implant</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><a name=\"fig4b\"></a><img alt=\"Figure 4\" src=\"/dailymed/image.cfm?name=susvimo-117.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">Figure 4</span>\n<br/>Incision to remove tissue that may be covering the implant flange and septum</td>\n</tr>\n<tr>\n<td align=\"center\"><a name=\"fig5b\"></a><img alt=\"Figure 5\" src=\"/dailymed/image.cfm?name=susvimo-118.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">Figure 5</span>\n<br/>Exposed implant</td>\n</tr>\n</tbody>\n</table></div>" }

4. Stabilize the globe and align the explant tool

{ "type": "p", "children": [], "text": "\n4.\tStabilize the globe and align the explant tool\n" }

{ "type": "ul", "children": [ "Stabilize the globe with forceps to prevent unwanted eye movement.", "With the explant tool oriented perpendicular to the globe, align the contoured tips with the long axis of the implant flange (Figure 6)." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><a name="fig6b"></a><img alt="Figure 6" src="/dailymed/image.cfm?name=susvimo-119.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td> </tr> <tr> <td align="center"><span class="Bold">Figure 6</span> <br/>Align the explant tool along the long axis of the implant flange</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><a name=\"fig6b\"></a><img alt=\"Figure 6\" src=\"/dailymed/image.cfm?name=susvimo-119.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">Figure 6</span>\n<br/>Align the explant tool along the long axis of the implant flange</td>\n</tr>\n</tbody>\n</table></div>" }

5. Grasp the implant

{ "type": "p", "children": [], "text": "\n5.\tGrasp the implant\n" }

Warning

{ "type": "p", "children": [], "text": "\nWarning\n" }

Do not grasp the implant by the short axis of the implant flange. Remove the implant in a gentle manner. Perpendicular exit of the implant is important to avoid contact between the implant and intraocular structures such as the lens.

{ "type": "p", "children": [], "text": "\nDo not grasp the implant by the short axis of the implant flange. Remove the implant in a gentle manner. Perpendicular exit of the implant is important to avoid contact between the implant and intraocular structures such as the lens." }

{ "type": "ul", "children": [ "Use the contoured tips of the explant tool to gently grasp underneath the long axis of the implant flange (Figure 7)." ], "text": "" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><a name="fig7b"></a><img alt="Figure 7" src="/dailymed/image.cfm?name=susvimo-121.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td> </tr> <tr> <td align="center"><span class="Bold">Figure 7</span> <br/>Grasp underneath the long axis of the implant flange</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><a name=\"fig7b\"></a><img alt=\"Figure 7\" src=\"/dailymed/image.cfm?name=susvimo-121.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">Figure 7</span>\n<br/>Grasp underneath the long axis of the implant flange</td>\n</tr>\n</tbody>\n</table></div>" }

6. Remove the implant

{ "type": "p", "children": [], "text": "\n6.\tRemove the implant\n" }

{ "type": "ul", "children": [ "Once the implant is secured in the explant tool, in a gentle manner pull the implant from the eye in a perpendicular motion to avoid contact with adjacent intraocular structures.", "During removal, use forceps to stabilize the globe and provide counter traction to help release the surrounding tissue (Figure 8).", "During removal, continue to maintain perpendicular orientation of the implant relative to the globe (Figure 9).\n\n\n\n\n\n\nFigure 8\nImplant removal\n\n\n\n\n\nFigure 9\nPerpendicular exit of the implant\n\n\n\n", "If needed per the surgeon's discretion, the infusion line on the vitrectomy surgical system can be turned on during implant removal.", "Control any scleral or conjunctival bleeding, using cauterization if needed, and clear any vitreous prolapse present within or around the scleral wound using a vitrectomy setup. \t\t\t\t\t\t\n\n\n\n\n\n\nFigure 10\nAppearance of the scleral wound after implant removal\n\n\n\n" ], "text": "" }

7. Suture the sclera

{ "type": "p", "children": [], "text": "\n7.\tSuture the sclera\n" }

{ "type": "ul", "children": [ "\nCompletely close the scleral incision with non-absorbable (suggested Nylon) sutures (Figure 11). More than one suture will be needed to close the wound. It is recommended to place equally spaced partial thickness interrupted sutures.", "Ensure that the knots are buried." ], "text": "" }

Caution

{ "type": "p", "children": [], "text": "\nCaution\n" }

Do not overtighten the scleral sutures, to minimize excessive tensions on the sclera or cornea.

{ "type": "p", "children": [], "text": "\nDo not overtighten the scleral sutures, to minimize excessive tensions on the sclera or cornea." }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><a name="fig11b"></a><img alt="Figure 11" src="/dailymed/image.cfm?name=susvimo-126.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td> </tr> <tr> <td align="center"><span class="Bold">Figure 11</span> <br/>Suture scleral wound using multiple sutures</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><a name=\"fig11b\"></a><img alt=\"Figure 11\" src=\"/dailymed/image.cfm?name=susvimo-126.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">Figure 11</span>\n<br/>Suture scleral wound using multiple sutures</td>\n</tr>\n</tbody>\n</table></div>" }

8. Suture conjunctiva

{ "type": "p", "children": [], "text": "\n8.\tSuture conjunctiva\n" }

{ "type": "ul", "children": [ "Close Tenon's capsule and conjunctiva to completely cover the scleral incision (Figure 12)." ], "text": "" }

Caution

{ "type": "p", "children": [], "text": "\nCaution\n" }

Completely close Tenon's capsule and conjunctiva to minimize potential post-removal complications.

{ "type": "p", "children": [], "text": "Completely close Tenon's capsule and conjunctiva to minimize potential post-removal complications." }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col align="center" valign="middle" width="100%"/> <tbody class="Headless"> <tr> <td align="center"><a name="fig12b"></a><img alt="Figure 12" src="/dailymed/image.cfm?name=susvimo-128.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td> </tr> <tr> <td align="center"><span class="Bold">Figure 12</span> <br/>Suture conjunctiva post-removal</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col align=\"center\" valign=\"middle\" width=\"100%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\"><a name=\"fig12b\"></a><img alt=\"Figure 12\" src=\"/dailymed/image.cfm?name=susvimo-128.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td>\n</tr>\n<tr>\n<td align=\"center\"><span class=\"Bold\">Figure 12</span>\n<br/>Suture conjunctiva post-removal</td>\n</tr>\n</tbody>\n</table></div>" }

9. Remove infusion cannula

{ "type": "p", "children": [], "text": "\n9.\tRemove infusion cannula\n" }

{ "type": "ul", "children": [ "If the infusion was previously turned on, then set the infusion pressure to 20 mmHg before removing the infusion cannula.", "Place suture at infusion cannula site as needed." ], "text": "" }

10. Check Intraocular Pressure (IOP) using digital palpation

{ "type": "p", "children": [], "text": "\n10.\tCheck Intraocular Pressure (IOP) using digital palpation\n" }

11. Perform indirect ophthalmoscopy to examine for the presence of any complications

{ "type": "p", "children": [], "text": "\n11.\tPerform indirect ophthalmoscopy to examine for the presence of any complications\n" }

Disposal and Post-removal Procedures

{ "type": "p", "children": [], "text": "\t\t\t\t\t\t\tDisposal and Post-removal Procedures \t\t\t\t\t\t" }

1. Dispose of the used components

{ "type": "p", "children": [], "text": "\n1.\tDispose of the used components\n" }

{ "type": "ul", "children": [ "Dispose of the used explant tool together with the implant in a biohazard waste container or in accordance with local requirements." ], "text": "" }

2. Perform post-removal procedures

{ "type": "p", "children": [], "text": "\n2.\tPerform post-removal procedures\n" }

{ "type": "ul", "children": [ "Post-removal procedures are consistent with standard post-surgical procedures." ], "text": "" }

3. Post-removal patient instructions

{ "type": "p", "children": [], "text": "\n3.\tPost-removal patient instructions\n" }

{ "type": "ul", "children": [ "Provide the patient with the following post-operative instructions:\n–\nPositioning:\nKeep head above shoulder level for the rest of the day.\nSleep with head elevated on 3 or more pillows if lying down during the day and night after implant removal.\n\n\n–\nInformation on caring for the eye after the procedure, including but not limited to:\nMonitor for symptoms that may require immediate attention. \nWear an eye shield at bedtime for at least 7 nights.\n\nDo not participate in strenuous activities until 14 days following the implant removal procedure.\nAdminister all post-operative anti-inflammatory and antimicrobial drops, as directed by their physician.\n\n\n\n" ], "text": "" }

Explanation of symbols on product or package labeling

{ "type": "p", "children": [], "text": "Explanation of symbols on product or package labeling" }

<div class="scrollingtable"><table width="50%"> <caption> <span>Table 3 Symbols on blister tray and carton</span> </caption> <col align="center" valign="middle" width="20%"/> <col align="left" valign="middle" width="80%"/> <thead> <tr class="First Last"> <th align="left" class="Lrule Rrule">Symbol</th><th align="left" class="Rrule">Title</th> </tr> </thead> <tbody> <tr class="Botrule First"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-129.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Manufacturer</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-130.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Prescription only</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-131.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Do not re-use</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-132.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Do not use if package is damaged</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-133.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Consult Instructions for Use</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-134.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Sterilized by irradiation</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-135.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Temperature limit</td> </tr> <tr class="Botrule"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-136.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Expiration date/ Use by date</td> </tr> <tr class="Botrule Last"> <td align="center" class="Lrule Rrule"><img alt="Image" src="/dailymed/image.cfm?name=susvimo-137.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444"/></td><td align="left" class="Rrule">Lot/Batch number</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"50%\">\n<caption>\n<span>Table 3\tSymbols on blister tray and carton</span>\n</caption>\n<col align=\"center\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"80%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Lrule Rrule\">Symbol</th><th align=\"left\" class=\"Rrule\">Title</th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"Botrule First\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-129.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Manufacturer</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-130.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Prescription only</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-131.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Do not re-use</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-132.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Do not use if package is damaged</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-133.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Consult Instructions for Use</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-134.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Sterilized by irradiation</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-135.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Temperature limit</td>\n</tr>\n<tr class=\"Botrule\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-136.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Expiration date/ Use by date</td>\n</tr>\n<tr class=\"Botrule Last\">\n<td align=\"center\" class=\"Lrule Rrule\"><img alt=\"Image\" src=\"/dailymed/image.cfm?name=susvimo-137.jpg&amp;setid=9c6d9e2a-9a77-4d11-b692-de87cfde3444\"/></td><td align=\"left\" class=\"Rrule\">Lot/Batch number</td>\n</tr>\n</tbody>\n</table></div>" }

Manufactured by: Genentech, Inc. A Member of the Roche Group 1 DNA WaySouth San Francisco, CA 94080-4990

{ "type": "p", "children": [], "text": "Manufactured by: \nGenentech, Inc.\nA Member of the Roche Group 1 DNA WaySouth San Francisco, CA 94080-4990" }

U.S. License No.: 1048

{ "type": "p", "children": [], "text": "U.S. License No.: 1048" }

SUSVIMO is a trademark of Genentech, Inc. ©2021 Genentech, Inc.All rights reserved.

{ "type": "p", "children": [], "text": "SUSVIMO is a trademark of Genentech, Inc. ©2021 Genentech, Inc.All rights reserved." }

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the U.S. Food and Drug Administration." }

Approved: 10/2021

{ "type": "p", "children": [], "text": "Approved: 10/2021" }

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

{ "type": "p", "children": [], "text": "Representative sample of labeling (see the HOW SUPPLIED section for complete listing):" }

NDC 50242-078-55

{ "type": "p", "children": [], "text": "NDC 50242-078-55" }

Susvimo™(ranibizumab injection)

{ "type": "p", "children": [], "text": " Susvimo™(ranibizumab injection)" }

See instructions for useincluded with the Susvimo ocular implantwith insertion tool assembly

{ "type": "p", "children": [], "text": "See instructions for useincluded with the Susvimo ocular implantwith insertion tool assembly" }

100 mg/mL

{ "type": "p", "children": [], "text": " 100 mg/mL" }

Vial contains 10 mg/0.1 mL ranibizumab

{ "type": "p", "children": [], "text": "Vial contains 10 mg/0.1 mL ranibizumab" }

For use with Susvimo ocular implant

{ "type": "p", "children": [], "text": " For use with Susvimo ocular implant" }

Dispense the enclosed Medication Guide to each patient.

{ "type": "p", "children": [], "text": "Dispense the enclosed Medication Guide to each patient." }

Carton contents:

{ "type": "p", "children": [], "text": "Carton contents:" }

{ "type": "ul", "children": [ "One Susvimo single-dose vial", "One Susvimo initial fill needle" ], "text": "" }

Rx only

{ "type": "p", "children": [], "text": " Rx only" }

Genentech

{ "type": "p", "children": [], "text": "Genentech" }

10233586

{ "type": "p", "children": [], "text": "10233586" }

NDC 50242-078-12

{ "type": "p", "children": [], "text": "NDC 50242-078-12" }

Susvimo™(ranibizumab injection)

{ "type": "p", "children": [], "text": " Susvimo™(ranibizumab injection)" }

100 mg/mL

{ "type": "p", "children": [], "text": " 100 mg/mL" }

Vial contains 10 mg/0.1 mL ranibizumab

{ "type": "p", "children": [], "text": "Vial contains 10 mg/0.1 mL ranibizumab" }

For use with Susvimoocular implant

{ "type": "p", "children": [], "text": " For use with Susvimoocular implant" }

Dispense the enclosedMedication Guide to each patient.

{ "type": "p", "children": [], "text": "Dispense the enclosedMedication Guide to each patient." }

Rx only

{ "type": "p", "children": [], "text": " Rx only" }

1 Single-dose vial

{ "type": "p", "children": [], "text": "1 Single-dose vial" }

Genentech

{ "type": "p", "children": [], "text": "Genentech" }

10233583

{ "type": "p", "children": [], "text": "10233583" }