Patient enrollment is complete in two phase 3 clinical trials investigating faricimab in diabetic macular edema, according to correspondence from Genentech and Roche.
The YOSEMITE and RHINE studies will evaluate faricimab’s safety and efficacy in treating DME compared with aflibercept injection. More than 900 patients in each study will be randomly assigned to receive faricimab dosed every 8 weeks or sham injections; a personalized treatment interval or sham injections; or aflibercept dosed every 8 weeks or sham injections.
Change in best corrected visual acuity at 1 year is the primary endpoint of the studies.
Faricimab’s ability to simultaneously bind to and neutralize angiopoietin-2 and VEGF-A may lead to improved and sustained treatment efficacy.
Genentech and Roche are continuing patient enrollment in the phase 3 TENAYA and LUCERNE studies investigating faricimab for the treatment of wet age-related macular degeneration.