January 28, 2022
Genentech, a member of the Roche Group, today announced that the FDA has approved Vabysmo™ (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Vabysmo 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 given from one to four months apart following four initial monthly doses, potentially lowering treatment burden.
The approval is based on positive results across four Phase III studies in wet AMD and DME. The studies consistently showed that patients treated with Vabysmo given at intervals of up to four months achieved non-inferior vision gains versus aflibercept given every two months in the first year. Vabysmo was generally well tolerated in all four studies. The most common adverse reaction (≥5%) reported in patients receiving Vabysmo was conjunctival hemorrhage (7%). Two scientific papers and an editorial on these one-year results were recently published in The Lancet.