The FDA’s decision was supported by data from the Phase III Pavilion study, where patients receiving Susvimo with nine-month refills showed significantly greater improvements in the Diabetic Retinopathy Severity Scale (DRSS) compared to those on monthly observation with as-needed anti-VEGF injections. None of the patients receiving Susvimo required supplemental treatment within the first year, and the safety profile was consistent with previous findings.
Roche has announced 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 progressive eye disease that affects nearly 10 million people in the U.S. and over 100 million globally. This approval marks a significant advancement in retinal care, as Susvimo is the first and only FDA-approved continuous drug delivery system for DR that maintains vision with just one refill every nine months.
Susvimo is now available in the U.S. for retina specialists treating patients with DR who have previously responded to at least two anti-VEGF injections. Unlike traditional anti-VEGF therapies that often require monthly intravitreal injections, Susvimo delivers a customized ranibizumab formulation continuously via a surgically implanted Port Delivery System (PDS). This durable and refillable implant is inserted through a one-time, outpatient procedure and offers a consistent therapeutic dose directly into the eye.
“The approval of Susvimo for diabetic retinopathy expands treatment options for patients, offering predictable and immediate durability after implantation,” said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. “Patients are increasingly looking for longer-lasting therapies, and Susvimo meets that need.”
Dr. Carl Awh, vitreoretinal surgeon at Tennessee Retina, added, “Susvimo is a compelling new option for patients at risk of vision loss due to DR. It provides much-needed relief from frequent injections while offering effective disease control.”
Roche continues to innovate in ophthalmology, with the broadest retina pipeline in the industry, aiming to protect vision through science-driven, patient-informed therapies.