The FDA has approved Vabysmo (faricimab-svoa; Roche/Genentech) for the treatment of wet age-related macular degeneration (nAMD) and diabetic macular edema (DME), according to a statement released by Roche. With this milestone approval, Vabysmo is the lone injectable approved simultaneously in the United States for both AMD and DME, and the first bispecific antibody approved for the eye.
 
The FDA approval was based on positive results across 4 phase 3 studies: TENAYA and LUCERNE in patients with wet AMD, and YOSEMITE and RHINE in patients with DME. The studies consistently showed that patients treated with Vabysmo given at intervals of up to 4 months achieved noninferior vision gains vs aflibercept given every 2 months in the first year. "We now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time," Charles Wykoff, director of research at Retina Consultants of Texas and a Vabysmo trial investigator, said in a news release.
 
Vabysmo represents a new treatment approach by targeting and inhibiting angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Inhibition of both pathways has been shown in preclinical studies to have potentially complementary benefits, stabilizing vessels and thereby reducing vessel leakage and inflammation. Long-term extension studies for Vabysmo in people with wet AMD and DME are ongoing, and trials are also under way evaluating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion.

Vabysmo will be available in the coming weeks, according to Roche.