FDA Approves Genentech’s New Treatment For Wet Age-Related Macular Degeneration (AMD)
October 22nd, 2021
On October 22, 2021, the FDA approved Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Wet AMD impacts approximately 1.1 million people in the United States and is a leading cause of blindness in people aged 60 and older.
News in brief
- Susvimo is the first wet AMD treatment in 15 years to provide an alternative to standard-of-care eye injections needed as often as once a month.
- By continuously delivering medicine into the eye via a refillable implant, Susvimo may help people with wet AMD maintain their vision with as few as two treatments per year.
- The approval is supported by a positive Phase III trial that compared the safety and efficacy of Susvimo administered via the Susvimo eye implant, refilled every six months at fixed intervals, to monthly intravitreal injections of ranibizumab.
Important Safety Information
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, 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, 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 (NSAIDs).
- 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.
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). 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, 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 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, have eye discharge, or have watering in the eye. You may need medical or surgical treatment.
- Temporary decrease in vision after the SUSVIMO procedure.
The most common side effects of SUSVIMO include:
- 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.
“We believe that Susvimo can help people with wet AMD preserve their vision while potentially alleviating the treatment burden associated with current standards of care. Susvimo’s approval builds on Genentech's long-standing commitment to people living with vision-threatening conditions.”
Levi Garraway, M.D., Ph.D., Chief Medical Officer and head of Global Product Development