Genentech, a member of the Roche Group, announced the US Food and Drug Administration (FDA) approved Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME). 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, Genentech said in a press release. Susvimo is now available to United States retina specialists and their patients with DME.

The FDA's decision was based on positive 1-year results from the phase 3 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 6 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 2 more lines on an eye chart, compared to 9.4 letters, respectively). 

According to the company, Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform. Susvimo was first approved by the FDA for the treatment of wet, or neovascular age-related macular degeneration in 2021. 

Genentech said it is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech said it offers patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or www.Genentech-Access.com.