FDA Grants Approval For Roche’s Susvimo In Diabetic Retinopathy Patients

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a serious eye condition that can lead to blindness. DR affects nearly 10 million people in the United States and over 100 million worldwide. Susvimo is the first and only FDA-approved continuous delivery treatment for DR that requires just one refill every nine months to help maintain vision. Susvimo is now available to retina specialists in the U.S. for patients with DR who have already responded to at least two anti-vascular endothelial growth factor (VEGF) injections.

The FDA’s approval was based on positive results from the one-year phase III Pavilion study. Patients treated with Susvimo, refilled every nine months, showed greater improvement on the Diabetic Retinopathy Severity Scale (DRSS), which measures the extent of damage caused by diabetes to the eyes. Compared to patients receiving monthly clinical observation and anti-VEGF injections as needed, those on Susvimo experienced a reduction in the severity of their eye disease. None of the patients treated with Susvimo required additional treatments during the first year. The safety profile observed was consistent with what is already known about Susvimo.

Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development, said in a statement, “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. 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.”

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

Susvimo works by continuously delivering a customized form of ranibizumab through the Port Delivery Platform, a refillable eye implant. This implant is surgically placed into the eye in a one-time outpatient procedure and releases medication directly to the retina. This is different from other treatments that may require eye injections as often as monthly. Roche is committed to protecting vision by developing innovative therapies for eye diseases and currently has the broadest pipeline of retina treatments in ophthalmology. Their work is guided by scientific research and insights from patients living with eye conditions.