FDA nod for Genentech's Vabysmo

The US Food and Drug Administration has approved Vabysmo (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME), developed by Swiss pharma giant Roche’s (ROG: SIX) US biotech subsidiary Genentech.

Wet AMD and DME are two leading causes of vision loss among US adults. 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 the first and only FDA-approved injectable eye medicine for wet AMD and DME that improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses, based on evaluation of the patient’s anatomy and vision outcomes. Standard of care for wet AMD and DME typically requires eye injections every one to two months.

Vabysmo will be available in the USA in the coming weeks. The European Medicines Agency is also currently evaluating the Vabysmo Marketing Authorization Application for the treatment of wet AMD and DME.