FDA approves Susvimo as first continuous delivery treatment for diabetic macular edema

The U.S. Food and Drug Administration (FDA) has approved Genentech’s Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema (DME). This approval introduces the first continuous delivery treatment option for DME, offering an alternative to frequent eye injections.

The FDA’s decision is based on positive 1-year results from the Phase 3 Pagoda study, which demonstrated that Susvimo provided sustained vision improvements in people with DME. The safety profile was consistent with previous findings. In the study, patients receiving Susvimo every 6 months achieved vision gains comparable to those receiving monthly 0.5 mg ranibizumab intravitreal injections.

Susvimo utilizes the Port Delivery Platform to continuously deliver a customized formulation of ranibizumab, reducing the need for monthly injections. In 2021, the FDA approved Susvimo for treating neovascular, age-related macular degeneration.

Read the full press release here.