Posted by Michael Wonder on 24 Jul 2022
CHMP recommends EU approval of Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
22 July 2022 - The CHMP recommendation is based on results across four Phase 3 studies: TENAYA and LUCERNE in neovascular age-related macular degeneration at year one, and YOSEMITE and RHINE in diabetic macular oedema up to two years.
Roche today announced that the EMA's CHMP has adopted a positive opinion recommending the approval of Vabysmo (faricimab) for the treatment of neovascular or “wet” age-related macular degeneration and visual impairment due to diabetic macular oedema.
