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

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced detailed results from four Phase III studies of its investigational bispecific antibody, faricimab, for the treatment of diabetic macular edema (DME) and neovascular or “wet” age-related macular degeneration (nAMD). The studies consistently showed that faricimab, given at intervals of up to four months, offered non-inferior vision gains compared to aflibercept, given every two months. Approximately half of people eligible for extended dosing with faricimab were able to be treated every four months in the first year in the YOSEMITE and RHINE studies in DME and the TENAYA and LUCERNE studies in nAMD. Faricimab is the first injectable eye medicine to achieve this length of time between treatments in Phase III studies for DME and nAMD. Furthermore, approximately three-quarters of people eligible for extended dosing with faricimab were able to be treated every three months or longer in the first year. Faricimab was generally well-tolerated in all four studies, with no new or unexpected safety signals identified.

Results from the studies will be presented at Angiogenesis, Exudation, and Degeneration 2021, a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine, on Saturday, February 13.

“These faricimab data offer the promise of a new treatment for two common causes of blindness, diabetic macular edema and neovascular age-related macular degeneration," said Jeffrey Heier, M.D., Director of Retinal Research at Ophthalmic Consultants of Boston in Boston, Mass. “Faricimab’s potential to extend time between treatments may benefit those patients who struggle to keep up with the regular physician visits and eye injections needed to preserve their vision.”

While anti-vascular endothelial growth factor (VEGF) monotherapy injections have significantly reduced vision loss from DME and nAMD, the treatment burden associated with frequent eye injections and physician visits can lead to under-treatment and, potentially, less than optimal vision outcomes. Faricimab is the first investigational bispecific antibody designed for the eye. Unlike current treatments for DME and nAMD that inhibit the VEGF pathway, faricimab targets two distinct pathways – via angiopoietin-2 (Ang-2) and VEGF-A – that drive a number of retinal conditions. Through this novel mechanism of action, faricimab is designed to stabilize blood vessels and thereby reduce inflammation and leakage more than inhibiting either pathway alone. This may improve vision outcomes for longer than with anti-VEGF monotherapy, and in turn reduce the frequency of eye injections needed.