Faricimab demonstrates extended treatment interval in DME, wet AMD
New phase 3 results from four trials suggest faricimab could offer increased treatment intervals for patients with wet age-related macular degeneration or diabetic macular edema, according to a press release from Genentech.
Results showed faricimab, when administered at intervals of up to 4 months, offered noninferior vision gains compared with aflibercept administered every 2 months, the release said.
“These positive results show the potential for faricimab as the first new type of medicine in 15 years for people with neovascular age-related macular degeneration and in close to a decade in diabetic macular edema,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in the release.
YOSEMITE and RHINE are identical, randomized, multicenter, double-masked studies evaluating faricimab for the treatment of DME compared with aflibercept in 1,891 patients. The arms evaluated faricimab 6 mg administered at personalized dosing intervals of up to 4 months, faricimab 6 mg administered at fixed 2-month intervals and aflibercept 2 mg administered at fixed 2-month intervals.
TENAYA and LUCERNE are identical, randomized, multicenter, double-masked studies evaluating faricimab for the treatment of wet AMD in 1,329 patients. The arms investigated faricimab 6 mg administered at fixed intervals of 2, 3 or 4 months based on disease activity assessments at weeks 20 and 24 and aflibercept 2 mg administered at fixed 2-month intervals.
Faricimab demonstrated no new or unexpected safety signals across all four trials, the release said.
Genentech plans to file results from all four studies to the FDA and the European Medicines Agency seeking approval of faricimab to treat patients with DME or wet AMD.