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# Susvimo Approved for Diabetic Retinopathy
- URL: https://www.fdaweb.com/susvimo-approved-for-diabetic-retinopathy/
- Published: 2025-05-23T12:00:00.000Z
- Updated: 2026-09-14T15:12:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159236

FDA has approved Roche’s Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. “It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months,” the company says. Susvimo is described as a refillable eye implant surgically inserted into the eye during an outpatient procedure that continuously delivers a customized formulation of ranibizumab over time.

Approval was based on positive one-year results from the Phase 3 Pavilion study. In the study, those treated with Susvimo refilled every nine months saw a “reduction in the severity of eye damage caused by diabetes, compared with those under monthly clinical observation who were treated with anti-VEGF injections as needed based on disease progression,” the company says. “Additionally, none of the participants receiving Susvimo required supplemental treatment at one year. Safety was consistent with the known safety profile for Susvimo.”