Roche and Genentech are initiating two phase 3 global trials to investigate the bispecific molecule faricimab for the treatment of wet age-related macular degeneration, according to a communication from Genentech.
Nearly 1,300 patients with wet AMD will be included in the two identically designed phase 3 TENAYA and LUCERNE studies. The studies will evaluate the safety, efficacy and durability of faricimab compared with Eylea (aflibercept, Regeneron) for the treatment of wet AMD.
Patients will be randomly assigned to receive faricimab dosed every 16 weeks, with an option to drop to every 12 weeks or 8 weeks, or aflibercept dosed every 8 weeks. The primary endpoint of both studies is the change in best corrected visual acuity at week 48 from baseline.
Faricimab targets both Ang-2 and VEGF-A, which may lead to sustained efficacy at longer treatment intervals and improve vision outcomes for patients.
“The impact of wet AMD on patients, their families and caregivers is one of the reasons Genentech and Roche are dedicated to bringing novel treatments, like faricimab, to patients and their retina specialists. While effective therapies for wet AMD exist, the treatment burden may lead to less than optimal vision outcomes for many patients over time,” Carlos Quezada Ruiz, MD, medical director, ophthalmology, Genentech, said in the correspondence.
Faricimab is currently being studied in patients with diabetic macular edema in the phase 3 YOSEMITE and RHINE studies.