Roche’s Genentech announces FDA approval of Susvimo for diabetic retinopathy

Genentech announced that the U.S. Food and Drug Administration has approved Susvimo 100 mg/mL for the treatment of diabetic retinopathy, a potentially blinding condition that affects almost 10M people in the U.S. and more than 100 million people globally. Susvimo is now available to U.S. retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor injections. The FDA decision was based on 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. 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.