Genentech, a member of the Roche Group, has announced FDA approval of the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).

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, the company said. The Vabysmo PFS, which will become available to US retina specialists and their patients in the coming months, 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 Vabysmo PFS approval offers a convenient option for treating these leading causes of vision loss,” said Levi Garraway, MD, PhD, Genentech's chief medical officer, in a press release. “It builds on Vabysmo's established efficacy in improving vision and reducing retinal swelling.”