FDA Approves Genentech’s Susvimo for Diabetic Retinopathy

Genentech has received FDA approval for Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR). The approval makes Susvimo the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with one refill every 9 months. Susvimo is now available to US retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.

“The approval of Susvimo for diabetic retinopathy expands treatment options for patients, offering predictable and immediate durability after implantation with only one treatment every nine months,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a company news release. “Many patients with common retinal conditions seek alternative treatment options like Susvimo that can help preserve vision with longer intervals between treatments than regular eye injections.” 

The FDA decision was based on positive 1-year results from the phase 3 Pavilion study. People with DR who received Susvimo refilled every 9 months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS). There was a reduction in the severity of eye damage caused by diabetes compared with those under monthly clinical observation who were treated with anti-VEGF injections as needed based on disease progression. Additionally, none of the participants receiving Susvimo required supplemental treatment at 1 year. Safety was consistent with the known safety profile for Susvimo.

Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month. The Port Delivery Platform is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure, which introduces medicine directly into the eye, addressing certain retinal conditions that can cause vision loss.

Susvimo is now approved in the US for treat wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor inhibitor medication.