The U.S. Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR). This makes Susvimo the first and only FDA-approved continuous delivery system that can help maintain vision in people with DR with just one refill every nine months, according to manufacturer Genentech.
Susvimo is already approved for treating neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The new approval extends its use to patients with diabetic retinopathy who have responded to at least two previous injections of a VEGF inhibitor.
The treatment is delivered through a small implant inserted into the eye during a one-time outpatient procedure. The device slowly releases a customized form of ranibizumab, a VEGF inhibitor that blocks a protein linked to abnormal blood vessel growth and leakage in the eye.
Previously known as the Port Delivery System with ranibizumab, Susvimo was first approved for wet AMD in 2021 and later for DME in early 2025.
Dr. Levi Garraway, Chief Medical Officer at Genentech, said the approval offers a new option for patients with diabetic retinopathy. “Susvimo provides predictable and lasting results, requiring just one treatment every nine months,” he said in a press release. “Many patients prefer longer intervals between treatments compared to regular eye injections.”
The FDA’s decision was based on results from the Phase 3 Pavilion study, which involved 174 patients with diabetic retinopathy but no center-involved DME. Participants were randomly assigned to receive either the Susvimo implant or regular observation with occasional anti-VEGF injections as needed.
Patients treated with Susvimo showed significantly greater improvement on the Diabetic Retinopathy Severity Scale after one year. Those who received the implant did not require any additional treatment during that period.
Safety results were consistent with earlier trials. The most common side effects included eye redness or bleeding, sensitivity to light, and eye pain.
Susvimo’s expanded approval marks a step forward in providing long-term, effective treatment options for people living with diabetic eye disease.
