• Genentech, a member of the Roche Group (OTCQX:RHHBY) announces 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).
• 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, with a favorable benefit-risk profile.
• Vabysmo will be available in U.S. in the coming weeks. The EMA is also currently evaluating the Vabysmo Marketing Authorization Application for wet AMD and DME.
• 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