FDA approves Genentech’s Vabysmo Prefilled Syringe (PFS) for three leading causes of vision loss

Genentech, a member of the Roche Group announced today the U.S. Food and Drug Administration (FDA) has approved the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). 

The Vabysmo PFS will become available to the U.S. retina specialists and their patients in the coming months.

“Vabysmo PFS delivers the same medicine as the currently available Vabysmo vials in an alternative, ready-to-use format. Vabysmo will continue to be available in a 6.0 mg vial,” the statement informs.

“Vabysmo is the first and only bispecific antibody approved for the eye and has demonstrated rapid and robust vision improvements and retinal drying in wet AMD, DME and RVO. Retinal drying is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision,” it adds.

To date, Vabysmo is approved in more than 95 countries for wet AMD and DME, and in several countries, including the U.S. and Japan, for RVO. Review by other health authorities across the globe is ongoing. More than four million doses of Vabysmo have been distributed globally since its initial U.S. approval in 2022.