- Vabysmo (faricimab) simultaneously targets and inhibits two disease pathways that drive neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME)
- The CHMP recommendation is based on results across four phase III studies: TENAYA and LUCERNE in nAMD at year one, and YOSEMITE and RHINE in DME up to two years
- The totality of the data across all studies in nAMD and DME available to date showed that over 60% of people treated with Vabysmo were able to extend treatment to every four months, while improving and maintaining vision
- If approved, Vabysmo would offer the first new mechanism of action in over a decade for people in the EU with nAMD and DME
Basel, 22 July 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Vabysmo®️ (faricimab) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). Based on this recommendation, a final decision regarding the approval of Vabysmo is expected from the European Commission in the near future.
Neovascular AMD and DME are two leading causes of vision loss, together affecting over 40 million people worldwide. 1,2,3,4 The current standards of care typically require eye injections every one to two months. 5,6 Vabysmo has the potential to extend the time…
