CHMP recommends Vabysmo to treat neovascular or “wet” age-related macular degeneration and visual impairment due to diabetic macular edema
Roche has 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. The current standards of care typically require eye injections every one to two months. Vabysmo has the potential to extend the time between eye injections to up to four months while improving and maintaining vision. If approved, it would offer the first new mechanism of action in over a decade for people in the EU with these conditions.