Detailed data from phase III trials of RG 7716 shows efficacy in DME and nAMD.- Genentech/Roche

Genentech/Roche announced detailed results from four Phase III studies of its investigational bispecific antibody, RG 7716 (faricimab), for the treatment of diabetic macular edema (DME) and neovascular or “wet” age-related macular degeneration (nAMD). The studies consistently showed that faricimab, given at intervals of up to four months, offered non-inferior vision gains compared to aflibercept, given every two months. Approximately half of people eligible for extended dosing with faricimab were able to be treated every four months in the first year in the YOSEMITE and RHINE studies in DME and the TENAYA and LUCERNE studies in nAMD. Faricimab was generally well-tolerated in all four studies, with no new or unexpected safety signals identified. The YOSEMITE and RHINE studies in DME assessed two dosing regimens of faricimab given every two months or at personalized treatment intervals (PTI) of up to four months, compared to aflibercept given every two months. Patients in the PTI arm could receive treatment every one, two, three or four months, adjusted based on their disease activity. Both studies met their primary endpoint with faricimab consistently shown to offer non-inferior visual acuity gains to aflibercept. In YOSEMITE, the average vision gains from baseline were +11.6 and +10.7 eye chart letters in the faricimab PTI and two-month arms, respectively, and +10.9 letters in the aflibercept arm. In RHINE, the average vision gains from baseline were +10.8 and +11.8 letters in the faricimab PTI and two-month arms, respectively, and +10.3 letters in the aflibercept arm.The TENAYA and LUCERNE studies in nAMD assessed faricimab given at fixed intervals of every two, three or four months – selected based on their disease activity at weeks 20 and 24 – compared to aflibercept given every two months. Both studies met their primary endpoint, with faricimab consistently shown to offer non-inferior visual acuity gains to aflibercept. In TENAYA and LUCERNE, the average vision gains from baseline in the faricimab arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the aflibercept arms. Faricimab is the first injectable eye medicine to achieve this length of time between treatments in Phase III studies for DME and nAMD. Furthermore, approximately three-quarters of people eligible for extended dosing with faricimab were able to be treated every three months or longer in the first year. Results from the studies will be presented at Angiogenesis, Exudation, and Degeneration 2021, a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine, on Saturday, February 13.