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# Genentech sBLA for Susvimo Accepted for Review
- URL: https://www.fdaweb.com/genentech-sbla-for-susvimo-accepted-for-review/
- Published: 2024-07-23T12:00:00.000Z
- Updated: 2026-09-14T14:36:08.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157414

FDA has accepted a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL, indicated for treating diabetic macular edema (DME) and diabetic retinopathy (DR), the two leading causes of vision loss in adults with diabetes. Susvimo is the first refillable eye implant that provides continuous delivery of ranibizumab through its port delivery platform.

The submission is based on one-year results from the Phase 3 Pagoda and Pavilion studies, which both met their primary endpoint. Data show that Susvimo demonstrated sustained efficacy over two years and safety consistent with the drug’s known safety profile. Currently, Susvimo is approved for treating wet, or neovascular, age-related macular degeneration.

Genentech notes that treatment for DME usually involves regular eye injections every one to four months. In the Pagoda study, people with DME who had their Susvimo implant refilled every six months achieved non-inferior visual acuity gains compared with those receiving monthly 0.5 mg ranibizumab intravitreal injections, the company says. In Pavilion, people with DR who received Susvimo refilled every nine months “achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared with participants under monthly clinical observation,” it says, adding that no subjects treated with Susvimo needed additional treatment with supplemental injections during the primary analyses study period (52 weeks), compared to 60% in the control arm.