New Phase III Data Show Genentech’s Faricimab Is the First Investigational Injectable Eye Medicine to Extend Time Between Treatments up to Four Months in Two Leading Causes of Vision Loss, Potentially Reducing Treatment Burden for Patients - Seite 2

“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,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “This is an exciting time for our ophthalmology clinical development program, with multiple Phase III successes for two medicines from our late-stage pipeline. We hope to bring these potential treatments to people living with vision-threatening retinal conditions as soon as possible.”

Study Results

The YOSEMITE and RHINE studies in DME assessed two dosing regimens of faricimab given every two months or at personalized treatment intervals (PTI) of up to four months, compared to aflibercept given every two months. Patients in the PTI arm could receive treatment every one, two, three or four months, adjusted based on their disease activity. Both studies met their primary endpoint with faricimab consistently shown to offer non-inferior visual acuity gains to aflibercept. In YOSEMITE, the average vision gains from baseline were +11.6 and +10.7 eye chart letters in the faricimab PTI and two-month arms, respectively, and +10.9 letters in the aflibercept arm. In RHINE, the average vision gains from baseline were +10.8 and +11.8 letters in the faricimab PTI and two-month arms, respectively, and +10.3 letters in the aflibercept arm.

A secondary endpoint in both studies measured the proportion of people in the faricimab PTI arm that achieved dosing schedules of every three or four months at the end of the first year. Importantly, 52.8% (n=151/286) of faricimab PTI patients in YOSEMITE and 51% (n=157/308) in RHINE achieved four-month dosing at one year. An additional 21% (n=60/286) of faricimab PTI patients in YOSEMITE and 20.1% (n=62/308) in RHINE achieved three-month dosing. Combined, more than 70% of faricimab PTI patients were able to go three months or longer between treatments at the end of the first year. In both studies, faricimab given at intervals of up to four months demonstrated greater reductions in central subfield thickness (CST) compared to aflibercept given every two months.