FDA approves Susvimo (ranibizumab injection) for diabetic retinopathy- Roche

Roche announced that the FDA has approved Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the US and more than 100 million people globally. It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine 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 FDA decision was based on positive one-year results from the phase III Pavilion study. People with DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS). This means 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 one year. Safety was consistent with the known safety profile for Susvimo.

Pavilion (NCT04503551) is a multicentre, randomised, US-based phase III study evaluating the efficacy, safety and pharmacokinetics of Susvimo (Port Delivery Platform with ranibizumab) 100 mg/mL refilled every nine months compared with people under monthly clinical observation, in 174 people with non-proliferative diabetic retinopathy (DR) without centre-involved diabetic macular edema. Participants were randomised 5:3 to receive either Susvimo with refills every nine months or monthly clinical observation, respectively. In the Susvimo arm, participants received two loading doses of intravitreal ranibizumab, before Susvimo implantation at week 4. The primary endpoint was the proportion of participants with at least a two-step improvement from baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at week 52. Following the primary analysis, participants initially in the clinical observation arm received two ranibizumab loading doses before Susvimo implantation at week 64.

Susvimo provides continuous delivery of a customised 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.

“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,” said Levi Garraway, Chief Medical Officer and Head of Global Product Development. “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.”

“Susvimo is a compelling new treatment for patients at risk of vision loss from progression of diabetic retinopathy,” said vitreoretinal surgeon, Dr. Carl Awh, Tennessee Retina, Tennessee.   “I am delighted to have this far more durable treatment available for my patients.”