FDA approves first bispecific eye antibody

Jan. 31, 2022

Roche's Genentech has been granted U.S. FDA approval to treat two leading causes of vision loss — wet age-related macular degeneration (AMD) and diabetic macular edema (DME) — with its new drug Vabysmo.

Vabysmo is the first FDA-approved bispecific antibody treatment for the eye. The treatment is an injectable medicine that improved and maintained vision for patients with wet AMD and DME in clinical trials. The approval comes following positive results from phase 3 studies that showed patient vision improving, or not declining, and being well-tolerated in patients.

“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,” said Charles Wykoff, director of research at Retina Consultants of Texas in Houston.

AMD and DME are both debilitating diseases that affect the macula, the part of the eye that provides sharp vision, as damaged blood vessels leak fluid and blood, and cause swelling. Vabysmo aims to prevent further destabilization of blood vessels in the eye, reducing inflammation and vessel leakage. The drug is injected directly into the eye over the course of four once-a-month treatments.

The San Francisco-based biotech expects to have the treatment on the market in the U.S. in the coming weeks. The treatment may also make its way to overseas markets, with the European Medicines Agency currently evaluating its Marketing Authorization Application.

The company has also been granted FDA approval for another vision-loss treatment. In October, Susvimo, a refillable ocular implant, was approved for use in patients with wet AMD.