Genentech: Faricimab Meets Primary Endpoint In Two Phase III Studies For Diabetic Macular Edema

Genentech, the U.S. unit of Swiss drug maker Roche Group (RHHBY), announced Monday positive topline results from two studies evaluating its investigational bispecific antibody, faricimab, in people living with diabetic macular edema or DME.

The identically designed global Phase III studies, YOSEMITE and RHINE, met their primary endpoint. Both studies showed that faricimab given every eight weeks and at personalized dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks.

Faricimab was generally well-tolerated with no new safety signals identified. The studies each have three treatment arms, with participants randomized to receive either faricimab or aflibercept at fixed eight-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 one.

The company noted that this is the first time any investigational medicine has achieved this level of durability in a Phase III study of people with DME.

Faricimab is the first investigational bispecific antibody designed for the eye.

In addition to the YOSEMITE and RHINE studies, the Phase III 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 III TENAYA and LUCERNE studies as a potential treatment for neovascular or “wet” age-related macular degeneration, an advanced form of AMD, which can cause rapid, severe and irreversible vision loss.

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