A new injectable treatment for two different types of eye disease — wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) — has been approved by the U.S. Food and Drug Administration, according to an announcement from the manufacturer, Genentech.
Vabysmo (faricimab-svoa) is a new type of treatment known as a bispecific antibody — and the first such treatment developed and approved to treat eye problems. It works by targeting and inhibiting two different disease pathways that play a role in both wet AMD and DME, according to Genentech. Vabysmo is given by injection to the eye by a qualified health care provider, starting with four monthly injections followed by further injections one to four months apart, depending on a person’s eye anatomy and vision outcomes. As of now, it is the only injectable treatment for both wet AMD and DME approved in the United States.
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FDA approval of Vabysmo is based largely on the results of four different clinical trials of people with wet AMD or DME. The studies showed that compared with another injectable treatment for wet AMD, known as Eylea (aflibercept), people who were treated with Vabysmo experienced vision gains that were not inferior to those associated with Eylea over the course of one year of treatment. In all four studies, Vabysmo showed a “favorable benefit-risk profile,” according to Genentech, with the most commonly reported adverse reaction — conjunctival hemorrhage, or bleeding underneath the outer layer of the eye — occurring in 7% of study participants who received the treatment.
While the typical dosing for Vabysmo involved four initial monthly doses followed by a variable timeline of further doses, the FDA also approved an alternative dosing regiment for DME that involves six initial monthly doses, followed by doses every two months. While the approved dosing recommendations allow for people to be treated with Vabysmo on an ongoing monthly basis, the clinical trials showed that post people didn’t experience any additional vision benefit from receiving the drug this often.
“Vabysmo represents […] a major advance in treating retinal conditions such as wet AMD and diabetic macular edema,” said Charles Wykoff, MD, director of research at Retina Consultants of Texas in Houston and a Vabysmo clinical trial investigator, in the Genentech announcement. “With Vabysmo, we now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time.”
Genentech continues to support ongoing “extension” studies of Vabysmo in people with wet AMD and DME, which are designed to evaluate the long-term safety and effectiveness of the drug for treating both conditions. Separate ongoing trials of the drug are designed to evaluate its safety and efficacy for treating macular edema following retinal vein occlusion, which occurs when a blood clot blocks a vein in the eye.
Want to learn more about keeping your eyes healthy with diabetes? Read “Diabetic Eye Exams: What to Know,” “Eating for Better Vision and Healthy Eyes,” and “Keeping Your Eyes Healthy” and watch “Diabetes and Your Eyes.”