FDA Approves Genentech's Susvimo for Diabetes-Related Blindness

Genentech, part of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Susvimo® (ranibizumab injection) 100 mg/mL as a treatment for diabetic macular edema (DME). DME is a significant cause of vision loss among adults with diabetes, impacting over 29 million people globally. Susvimo is notable for being the first and only FDA-approved therapy that helps maintain vision in individuals with DME while requiring fewer treatments compared to standard eye injections. This new treatment option is now accessible to retina specialists and their patients across the United States.

Levi Garraway, M.D., Ph.D., who serves as Genentech’s Chief Medical Officer and Head of Global Product Development, emphasized the impact of Susvimo, describing it as a novel, convenient alternative to regular eye injections for those with this potentially blinding condition. He also highlighted the growing prevalence of DME worldwide, noting that the approval of Susvimo underscores Genentech’s commitment to innovation and improving patient care.

Jordan Graff, M.D., a vitreoretinal surgeon at Barnet Dulaney Perkins Eye Center in Arizona, expressed enthusiasm about offering Susvimo to patients living with DME who prefer longer intervals between treatments due to their busy schedules. Having successfully conducted numerous Susvimo surgeries for patients with wet age-related macular degeneration, Dr. Graff has observed firsthand how the continuous delivery of medication with Susvimo can help preserve vision with fewer interventions. He looks forward to expanding Susvimo’s benefits to more patients in his clinic.

The FDA's approval of Susvimo was based on encouraging one-year outcomes from the Phase III Pagoda study. This study showed that Susvimo provided sustained vision improvements in individuals with DME, with a safety profile consistent with existing knowledge about the treatment. In the Pagoda study, participants receiving Susvimo every six months experienced improvements in vision comparable to those receiving monthly injections of 0.5 mg ranibizumab. Specifically, patients gained an average of 9.6 letters on an eye chart, similar to advancing two lines, while those receiving monthly injections gained an average of 9.4 letters.

Susvimo’s delivery system involves a Port Delivery Platform that continuously administers a customized formulation of ranibizumab. This system stands in contrast to other treatments that may necessitate frequent monthly injections. Initially approved by the FDA in 2021 for treating wet age-related macular degeneration (AMD), Susvimo represents a significant advancement in ocular care.

Genentech is committed to ensuring that patients have access to the medications they need and plans to offer comprehensive support services for those prescribed Susvimo. These services are designed to minimize barriers to access and facilitate reimbursement. For patients who meet specific criteria, Genentech offers assistance programs through Genentech Access Solutions.

Diabetic macular edema is a condition that affects around 750,000 individuals in the U.S. and 29 million worldwide. It is characterized by damage to the retinal blood vessels, leading to leakage and swelling in the macula, the central area of the retina responsible for sharp vision critical for activities like reading and driving. As diabetes prevalence increases, the number of people affected by DME is expected to rise, making advancements in treatment like Susvimo increasingly vital.