Genentech has announced positive topline results from its Phase III studies, TENAYA and LUCERNE, evaluating its new drug faricimab, for people with wet (neovascular) age-related macular degeneration (nAMD). Both studies have shown that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes as effective as those receiving Regeneron’s aflibercept (Eylea) injections every eight weeks.
Thus far, Regeneron’s aflibercept (Eylea) and Genentech’s ranabizumab (Lucentis) and off-label bevacizumab (Avastin), have been the only drugs shown to be safe and effective for only as long as eight weeks between injections. Another drug, brolucizumab (Beovu), has been shown to be effective for up to twelve weeks, but it is currently being investigated by the drug’s manufacturer, Novartis, for potential adverse events in some patients.
This is the first time this level of durability has been achieved in a Phase III study of an injectable eye medicine for nAMD. In both studies, faricimab was generally well-tolerated, with no new or unexpected safety signals identified. The faricimab studies are expected to be completed in September 2021.