On Feb. 4, 2025, Genentech announced that the U.S. Food and Drug Administration (FDA) had approved Susvimo^® (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes, affecting more than 29 million adults worldwide.

Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections. Susvimo is now available to U.S. retina specialists and their patients with DME.

The FDA decision was based on positive one-year results from the Phase III Pagoda study, which showed that Susvimo demonstrated sustained vision improvements in people with DME, with safety consistent with the known safety profile for Susvimo. In Pagoda, people with DME who received Susvimo refilled every six months achieved non-inferior improvements in vision compared with those receiving monthly 0.5 mg ranibizumab intravitreal injections (9.6 eye chart letters, similar to gaining two more lines on an eye chart, compared to 9.4 letters, respectively). 

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. Susvimo was first approved by the FDA for the treatment of wet, or neovascular age-related macular degeneration (AMD) in 2021. 

Affecting approximately 750,000 people in the U.S. and 29 million people globally, diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated. DME occurs when damaged blood vessels in the retina leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving. The number of people with DME is expected to grow as the prevalence of diabetes increases.