Genentech announced positive top-line results from 2 identically designed large-scale global phase 3 studies, YOSEMITE and RHINE, evaluating its investigational bispecific antibody, faricimab, in people with diabetic macular edema (DME). Both studies met their primary endpoint and showed that faricimab given every 8 weeks and at personalized dosing intervals of up to 16 weeks demonstrated noninferior visual acuity gains compared to aflibercept (Eylea; Regeneron) given every 8 weeks. Faricimab was generally well tolerated with no new safety signals identified. The studies each have 3 treatment arms, with participants randomized to receive either faricimab or aflibercept at fixed 8-week intervals, or faricimab at personalized intervals of up to 16 weeks, following a loading phase. In a secondary endpoint, across both studies, more than half of participants in the faricimab personalized dosing arms achieved an extended time between treatments of 16 weeks at year 1.

Faricimab is the first investigational bispecific antibody designed for the eye. It targets 2 distinct pathways — angiopoietin-2 (Ang-2) and VEGF-A — that drive a number of retinal conditions, including DME.

“These positive results show that faricimab has the potential to offer lasting vision improvements for people with diabetic macular edema, while also reducing the treatment burden associated with frequent eye injections,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, in a news release.

In addition to the YOSEMITE and RHINE studies, the phase 3 Rhone-X study is investigating the long-term safety and tolerability of faricimab for the treatment of DME. Faricimab is also being studied in the phase 3 TENAYA and LUCERNE studies as a potential treatment for wet AMD.

YOSEMITE and RHINE are identical, randomized, multicenter, double-masked, global phase 3 studies, evaluating the efficacy and safety of faricimab compared to aflibercept in 1,891 people with DME (940 in YOSEMITE and 951 in RHINE). The studies each have 3 treatment arms: faricimab 6.0 mg administered at personalized dosing intervals of up to 16 weeks; faricimab 6.0 mg administered at fixed 8-week intervals; and aflibercept 2.0 mg administered at fixed 8-week intervals.