FDA Approves Susvimo for Diabetic Macular Edema (DME)

The FDA has approved Genentech's Susvimo ocular implant (ranibizumab) 100 mg/mL for the treatment of diabetic macular edema (DME). The approval makes Susvimo 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 commercailly available in the US. EyewireTV's coverage of the approval can be found here.

“Susvimo presents a unique, convenient treatment alternative to routine eye injections for people with a potentially blinding diabetic eye condition,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a company news release. “As the global prevalence of this condition continues to grow, today's FDA approval for Susvimo reflects our dedication to innovation and enhancing the patient experience.”

The FDA 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 noninferior improvements in vision compared with those receiving monthly 0.5 mg ranibizumab intravitreal injections (9.6 eye chart letters, compared to 9.4 letters, respectively).

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 age-related macular degeneration (AMD) in 2021.

Genentech said it is offering patient assistance programs through Genentech Access Solutions. More information is available at (866) 4ACCESS/(866) 422-2377 or https://www.Genentech-Access.com.