FDA Approves Genentech’s Vabysmo Prefilled Syringe for AMD, DME, and RVO

Genentech announced FDA approval of Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema after retinal vein occlusion (RVO). The company advised that Vabysmo PFS will be available in the United States in the coming months.

Vabysmo is a bispecific antibody approved for the eye that has demonstrated rapid and robust vision improvements and retinal drying in wet AMD, DME, and RVO, according to Genentech. 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.

In January 2022, the FDA approved Vabysmo for the treatment of wet AMD and DME, marking the first bispecific antibody approved for the eye. Vabysmo targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). 

Vabysmo is now approved in more than 95 countries for wet AMD and DME, and in several countries, including the United States and Japan, for RVO.