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FDA Approves Genentech’s Susvimo for Diabetic Retinopathy

24 May 2025
Admin
News Article

FDA Approves Genentech’s Susvimo for Diabetic Retinopathy

Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR) — a sight-threatening complication of diabetes affecting nearly 10 million people in the U.S. and over 100 million worldwide.

A Groundbreaking Advancement in Retinal Care

Susvimo is the first and only FDA-approved continuous delivery system for DR.
Delivers ranibizumab with just one refill every nine months, offering significantly extended treatment intervals compared to monthly anti-VEGF injections.
Approved for patients who previously responded to at least two anti-VEGF injections.

Expert Perspectives

“Susvimo offers immediate and predictable durability after implantation, transforming how we manage diabetic retinopathy.”

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development, Genentech

“This far more durable treatment option is a compelling choice for patients at risk of vision loss due to DR progression.”

— Carl Awh, M.D., Vitreoretinal Surgeon, Tennessee Retina

FDA Approval Based on Strong Phase III Data

The approval is backed by data from the Phase III Pavilion study, which demonstrated that patients receiving Susvimo every nine months showed superior improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared to those receiving as-needed anti-VEGF injections.

No participants on Susvimo needed supplemental treatment at one year.
Safety results were consistent with its known profile.

How Susvimo Works

Delivers a customized ranibizumab formulation via the Port Delivery Platform
Refillable implant is surgically inserted during a one-time outpatient procedure
Provides continuous, direct intraocular drug delivery, reducing treatment burden and enhancing adherence

This innovation represents a major step forward in retinal disease management, enabling sustained vision preservation with fewer clinic visits and improved quality of life for patients.