Shots:

• The approval was based on the 4 P-III (TENAYA & LUCERNE) & (YOSEMITE & RHINE DME) studies evaluating faricimab vs aflibercept in 1329 & 1891 patients with wet AMD & DME. The product is expected to be available in the US in the coming wks.
• The results showed that patients treated with Vabysmo were given ~4mos. achieved non-inferior vision gains over aflibercept that administered q2mos. in the 1st yr., was well tolerated with a favorable benefit-risk profile
• Vabysmo is 1st FDA-approved injectable eye product for wet AMD & DME that improves & maintains vision while EMA is evaluating faricimab’s MAA for the same indication. The (COMINO) & (BALATON) trials are underway for macular edema

Ref: Genentech | Image: Slide Genius