FDA Approves Genentech's Susvimo for Diabetic Eye Disease

Genentech, part of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) for treating diabetic retinopathy (DR), a serious eye condition affecting nearly 10 million Americans and over 100 million individuals globally. Susvimo is distinguished as the first FDA-approved continuous delivery treatment for DR, capable of preserving vision with a single refill every nine months. This approval means retina specialists in the United States can offer Susvimo to patients with DR who have responded positively to at least two previous anti-vascular endothelial growth factor (VEGF) injections.

Dr. Levi Garraway, Genentech’s Chief Medical Officer, highlighted the significance of Susvimo's approval in expanding treatment options for patients with retinal conditions. The treatment provides extended intervals between interventions, which is a welcomed alternative for many who prefer fewer injections. Vitreoretinal surgeon Dr. Carl Awh from Tennessee Retina expressed enthusiasm for the availability of Susvimo, acknowledging its potential to help patients at risk of vision loss due to DR progression.

The FDA's decision was influenced by the successful outcomes of the Phase III Pavilion study. In this study, individuals treated with Susvimo demonstrated substantial improvement on the Diabetic Retinopathy Severity Scale (DRSS), indicating a reduced severity of eye damage due to diabetes when compared to those needing frequent anti-VEGF injections. Importantly, none of the patients receiving Susvimo required additional treatment within a year, and its safety profile remained consistent with expectations.

Susvimo delivers ranibizumab continuously through the Port Delivery Platform, a refillable eye implant placed during a one-time outpatient procedure. This platform introduces medication directly into the eye, addressing certain retinal conditions linked to vision loss, while reducing the frequency of treatment compared to existing therapies that may require monthly injections.

Genentech is dedicated to ensuring patients can access their prescribed medications and offers extensive services to facilitate Susvimo's availability, minimizing hurdles related to access and reimbursement. The company is committed to supporting people prescribed Susvimo through Genentech Access Solutions, offering patient assistance programs for those who qualify.

Diabetic retinopathy (DR) is a major cause of blindness, affecting millions globally. It can lead to diabetic macular edema (DME), which significantly contributes to vision impairment. The risk of developing DR increases with the duration of diabetes, particularly if poorly managed. DR occurs when blood vessels in the retina sustain damage, potentially causing vision loss if they leak blood or fluid into the eye.

The Pavilion study investigated the efficacy, safety, and pharmacokinetics of Susvimo. Involving 174 participants, this study compared Susvimo, refilled every nine months, to monthly clinical observations. Participants receiving Susvimo showed significant improvement on the Diabetic Retinopathy Severity Scale after 52 weeks.

Susvimo offers a unique treatment method by delivering ranibizumab—a VEGF inhibitor designed to curb the formation of new blood vessels and their leakage—via an ocular implant. Previously known as the Port Delivery System, Susvimo distinguishes itself from Lucentis®, another ranibizumab-based treatment for wet age-related macular degeneration (AMD) and other retinal conditions.

In conclusion, Susvimo's approval marks a pivotal advancement in diabetic retinopathy management by reducing treatment frequency while maintaining effectiveness, thus offering a promising solution for many patients battling this challenging condition.