New FDA approval for Roche’s Vabysmo

The US Food and Drug Administration (FDA) has approved Swiss Pharma giant Roche’s (ROG: SIX) Vabysmo (faricimab) 6.0mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).

Together, these three conditions affect close to 80 million people globally. The Vabysmo PFS will become available to United States (US) retina specialists and their patients in the coming months.

Vabysmo, which gained US Food and Drug Administration (FDA) approval in January 2022, had sales of around $927 million in the first quarter of this year, and is now Roche’s fourth biggest seller.