Phase III TENAYA and LUCERNE studies of RG 7716 meet primary endpoints in age-related macular degeneration.- Genentech/Roche

Genentech/Roche announced positive topline results from two identically designed global Phase III studies, TENAYA and LUCERNE, evaluating its investigational bispecific antibody, RG 7716 (faricimab) in people living with neovascular or “wet” age-related macular degeneration (nAMD). Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving aflibercept injections every eight weeks. Nearly half (45%) of people in both studies were treated with faricimab every 16 weeks during the first year. This is the first time this level of durability has been achieved in a Phase III study of an injectable eye medicine for nAMD. In both studies, faricimab was generally well-tolerated, with no new or unexpected safety signals identified. The findings from TENAYA and LUCERNE build on positive topline results from the Phase III YOSEMITE and RHINE studies, announced in December 2020, which support the potential of faricimab as a treatment option for diabetic macular edema, a leading cause of vision loss among working-age adults. Detailed results from all four studies will be presented in February at Angiogenesis, Exudation, and Degeneration 2021, a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine, and submitted for approval to health authorities around the world, including the FDA and EMA.