FDA Approves Ranibizumab Ocular Implant for Patients With Age-Related Macular Degeneration

Officials with the FDA have approved ranibizumab (Susvimo, Genentech) 100 mg/mL injection 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 2 anti-vascular endothelial growth factor (VEGF) injections. Wet AMD—a condition that could potentially result in blindness—requires treatment with eye injections as frequently as once a month. According to the investigators, Susvimo is the first and only FDA-approved treatment for wet AMD that offers as few as 2 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, MD, chief of Retina Service at Wills Eye Hospital in Philadelphia, in a press release. “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 continuous ranibizumab, offering individuals with wet AMD an alternative to the potentially monthly anti-VEGF eye injections. The implant is inserted during a 1-time outpatient procedure and is refilled every 6 months. Further, supplemental ranibizumab injections can be given to the affected eye while the 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, MD, PhD, chief medical officer and head of Global Product Development at Genentech, in the release. “Susvimo’s approval builds on Genentech's long-standing commitment to people living with vision-threatening conditions.”

The approval is based on the primary analysis of the phase 3 Archway study, which demonstrated wet AMD patients treated with Susvimo achieved and maintained vision gains equivalent to monthly ranibizumab injections at weeks 36 and 40 of treatment. Further, only 1.6% of patients receiving Susvimo also received supplemental ranibizumab treatment before their first refill, and more than 98% could go 6 months before their first refill, according to the investigators.

Although Susvimo was generally well-tolerated with a favorable benefit-risk profile, the implant has been associated with a rate of endophthalmitis 3 times higher than monthly intravitreal injections of ranibizumab. The study found that many of these events were associated with conjunctival retractions or erosions. Investigators recommend reducing the risk of endophthalmitis through appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions.

REFERENCE

FDA approves Genentech’s Susvimo, a first-of-its-kind therapeutic approach for wet age-related macular degeneration (AMD) [news release]. Genentech; October 22, 2021. Accessed October 25, 2021. https://www.gene.com/media/press-releases/14935/2021-10-22/fda-approves-genentechs-susvimo-a-first-