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SUSVIMO® can significantly
improve DR*†

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Most people experienced a 2-step or more improvement in their symptom severity score compared to monitoring by the retina specialist.*†

2-step or more improvement on the DR severity scale*†

SUSVIMO could take you from moderately severe to mild DR

DR improvement with treatment every 9 months*†‡

That could mean only one refill a year‡

In clinical trials, SUSVIMO has been associated with an up to 3-fold higher rate of an eye infection called endophthalmitis (1.7% of participants) than monthly ranibizumab injections (0.5% of participants) in people with neovascular (wet) age-related macular degeneration (AMD). For DR, there were no cases (0/105) of endophthalmitis in people receiving SUSVIMO up to week 52. When including the extension phase of the clinical trial, 0.8% (1/128) of people receiving the ranibizumab implant experienced an episode of endophthalmitis.

In a clinical trial, 106 people received SUSVIMO, while 68 people were observed in a clinical setting. More people on SUSVIMO (80.1%) were able to achieve a 2-step or more improvement on the DR severity scale vs those in clinical observation (9%) at week 52.
 †There was a temporary decrease in vision following the SUSVIMO procedure; however, your vision will return to normal as your eye recovers from the procedure. ‡If your retina specialist determines that it is necessary, you may need an anti-VEGF injection in the gel-like part of the SUSVIMO treated eye (intravitreal) before your next refill. Additional treatment was not required for any participants in the first 9 months. In the following 9 months, 1% of patients received additional treatment.

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Important Safety Information

What is SUSVIMO® (ranibizumab injection)?

SUSVIMO (ranibizumab injection) is a prescription medicine used to treat adults with neovascular (wet) Age‑related Macular Degeneration (AMD), diabetic macular edema (DME), and 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).
 

It is not known if SUSVIMO is safe and effective in children.

What is the most important information I should know about SUSVIMO?

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:

  • An eye infection (endophthalmitis). Endophthalmitis is an infection of the eyeball that can cause permanent damage to your eye, including blindness. 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. Endophthalmitis requires urgent (same-day) medical or surgical treatment 
  • A missing layer on top of the white part of the eye (conjunctival erosion). 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. Call your healthcare provider right away if you have a sudden feeling that something is in your eye (foreign body sensation), if you have eye discharge, or watering of the eye. Conjunctival erosion may require surgical treatment
  • An opening of the layer that covers the white part of the eye (conjunctival retraction). 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. Call your healthcare provider right away if you have a sudden feeling that something is in your eye (foreign body sensation), if you have eye discharge, or watering of the eye. Conjunctival retraction may require surgical treatment
     

Do not receive SUSVIMO if you:

  • Have an infection in or around your eye
  • Have active swelling around your eye that may include pain and redness
  • Are allergic to ranibizumab or any of the ingredients in SUSVIMO

Talk to your healthcare provider before receiving SUSVIMO if you have any of these conditions.
 

Before receiving SUSVIMO, tell your healthcare provider about all of your medical conditions, including if you:

  • 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 (such as ibuprofen)
  • 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
  • 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

Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements.
 

What are other possible side effects of SUSVIMO?
The SUSVIMO implant and the procedures to insert, fill, refill, and remove the eye (ocular) implant can cause other serious side effects, including:

  • Tear and separation of layers of the retina (rhegmatogenous retinal detachment): This 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, or have a change in, or a loss of vision. Rhegmatogenous retinal detachment requires surgical treatment
  • Implant movement (implant dislocation): 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
  • Implant damage: Damage to the implant that prevents continued treatment (refills) with SUSVIMO. If the implant is not able to be properly refilled, your wet AMD or DME may be inadequately treated and your physician may remove the implant and/or change your treatment
  • Bleeding (vitreous hemorrhage): 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
  • Bump on top of the white layer of the eye (conjunctival bleb): 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 of the eye. You may need medical or surgical treatment
  • Temporary decrease in vision after the SUSVIMO procedure
     

What are the most common side effects of SUSVIMO?

  • Blood on the white of the eye
  • Eye pain
  • Redness in the white of the eye
  • Sensitivity to light

These are not all the possible side effects of SUSVIMO. 
 

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555. 

Please see Important Safety Information, including Serious Side Effects, as well as the SUSVIMO full Prescribing Information and Medication Guide.

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    • SUSVIMO [package insert]. South San Francisco, CA: Genentech, Inc; 2022.

      SUSVIMO [package insert]. South San Francisco, CA: Genentech, Inc; 2022.

    • Campochiaro PA, Marcus DM, Awh CC, et al. The port delivery system with ranibizumab for neovascular age-related macular degeneration. Ophthalmology. 2019;126:1141-1154.

      Campochiaro PA, Marcus DM, Awh CC, et al. The port delivery system with ranibizumab for neovascular age-related macular degeneration. Ophthalmology. 2019;126:1141-1154.

    • SUSVIMO Initial Fill and Implant Procedure Instructions for Use. Genentech, Inc. 2022.

      SUSVIMO Initial Fill and Implant Procedure Instructions for Use. Genentech, Inc. 2022.

    • Monés J, Gune S, Maia M, et al. Pharmacokinetic profile of the port delivery system with ranibizumab in the phase 3 Archway trial. Presented at 21st EURETINA Congress, September 9-12, 2021.

      Monés J, Gune S, Maia M, et al. Pharmacokinetic profile of the port delivery system with ranibizumab in the phase 3 Archway trial. Presented at 21st EURETINA Congress, September 9-12, 2021.

    • Ranade SV, Wieland MR, Tam T, et al. The port delivery system with ranibizumab: a new paradigm for long-acting retinal drug delivery. Drug Delivery. 2022;29(1):1326-1334.

      Ranade SV, Wieland MR, Tam T, et al. The port delivery system with ranibizumab: a new paradigm for long-acting retinal drug delivery. Drug Delivery. 2022;29(1):1326-1334.

    • Data on file. Genentech, Inc. 2021.

      Data on file. Genentech, Inc. 2021.

    • Data on file. Genentech, Inc. 2021.

      Data on file. Genentech, Inc. 2021.

    • Holekamp NM, Campochiaro PA, Chang MA, et al; Archway Investigators. Archway randomized phase 3 trial of the port delivery system with ranibizumab for neovascular age-related macular degeneration. Ophthalmology. 2022;129(3):295-307.

      Holekamp NM, Campochiaro PA, Chang MA, et al; Archway Investigators. Archway randomized phase 3 trial of the port delivery system with ranibizumab for neovascular age-related macular degeneration. Ophthalmology. 2022;129(3):295-307.

    • A phase III study to evaluate the port delivery system with ranibizumab compared with monthly ranibizumab injections in participants with wet age-related macular degeneration. ClinicalTrials.gov identifier: NCT03677934. Updated July 22, 2021. https://clinicaltrials.gov/ct2/show/NCT03677934

      A phase III study to evaluate the port delivery system with ranibizumab compared with monthly ranibizumab injections in participants with wet age-related macular degeneration. ClinicalTrials.gov identifier: NCT03677934. Updated July 22, 2021. https://clinicaltrials.gov/ct2/show/NCT03677934

    • Wykoff CC; Archway Investigators. 2-year outcomes from the phase 3 Archway trial: management of neovascular age-related macular degeneration using the port delivery system with ranibizumab (PDS). Presented at Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration 2022 – Virtual Edition, February 11-12, 2022.

      Wykoff CC; Archway Investigators. 2-year outcomes from the phase 3 Archway trial: management of neovascular age-related macular degeneration using the port delivery system with ranibizumab (PDS). Presented at Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration 2022 – Virtual Edition, February 11-12, 2022.

    • Data on file. Genentech, Inc. 2021.

      Data on file. Genentech, Inc. 2021.

    • Data on file. Genentech, Inc. 2021.

      Data on file. Genentech, Inc. 2021.

    • Chang MA, Kapre A, Kaufman D, et al. Patient preference and treatment satisfaction with a port delivery system for ranibizumab vs intravitreal injections in patients with neovascular age-related macular degeneration: a randomized clinical trial. JAMA Ophthalmology. Published online June 16, 2022.

      Chang MA, Kapre A, Kaufman D, et al. Patient preference and treatment satisfaction with a port delivery system for ranibizumab vs intravitreal injections in patients with neovascular age-related macular degeneration: a randomized clinical trial. JAMA Ophthalmology. Published online June 16, 2022.