FDA Approves Genentech’s Susvimo, a First-of-Its-Kind Therapeutic Approach for Wet Age-Related Macular Degeneration (AMD)

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Wet AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month. Susvimo, previously called Port Delivery System with ranibizumab, is the first and only FDA-approved treatment for wet AMD that offers as few as two treatments per year.

“Susvimo represents a major advancement in the treatment of retinal disease, and is an important new option for patients with wet AMD,” said Carl Regillo, M.D., Chief of Retina Service at Wills Eye Hospital in Philadelphia and an Archway study investigator. “With Susvimo, my patients now have an option that can help them maintain their vision as well as anti-VEGF injections, but on a more manageable twice-yearly treatment schedule.”

Susvimo delivers ranibizumab continuously, offering people living with wet AMD an alternative to anti-VEGF eye injections needed as often as once a month. The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months. If necessary, supplemental ranibizumab treatment can be given to the affected eye while the Susvimo implant is in place.

“We believe that Susvimo can help people with wet AMD preserve their vision while potentially alleviating the treatment burden associated with current standards of care,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Susvimo’s approval builds on Genentech’s long-standing commitment to people living with vision-threatening conditions.”

The approval is based on positive results from the Phase III Archway study primary analysis, which showed wet AMD patients treated with Susvimo achieved and maintained vision gains equivalent to monthly ranibizumab injections – +0.2 and +0.5 eye chart letters from baseline, respectively – at weeks 36 and 40 of treatment. In addition, only 1.6% of Susvimo patients received supplemental ranibizumab treatment before their first refill, and more than 98% could go six months before their first refill.

In the Archway study, Susvimo was generally well-tolerated, with a favorable benefit-risk profile. However, the Susvimo implant has been associated with a three-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis. In clinical trials, 2.0% of patients receiving a ranibizumab implant experienced at least one episode of endophthalmitis. The most common adverse events (AEs) were conjunctival hemorrhage, conjunctival hyperemia, iritis and eye pain. The safety profile of Susvimo in the clinical trial setting is well understood and will continue to be monitored closely.

Genentech has a robust Phase III clinical development program for Susvimo, including the Portal, Pagoda, Pavilion and Velodrome studies. Portal is an extension study evaluating the long-term safety and efficacy of Susvimo in wet AMD. Pagoda is evaluating Susvimo for the treatment of people with diabetic macular edema (DME), while Pavilion is a study of Susvimo in diabetic retinopathy without DME. Velodrome is evaluating Susvimo refilled every nine months in wet AMD. Susvimo is also currently under review for the treatment of wet AMD by the European Medicines Agency (EMA).

Susvimo will be available in the United States in the coming months. Genentech is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions.

Genentech’s late-stage ophthalmology portfolio also includes faricimab, a bispecific antibody under FDA and EMA review for the treatment of wet AMD and DME. The FDA is additionally reviewing faricimab for the treatment of diabetic retinopathy.

Genentech developed the first anti-VEGF medicine that not only slowed the progression of wet AMD, but restored vision for many patients. Lucentis® (ranibizumab injection) was first approved for wet AMD by the FDA in 2006.