Roche’s faricimab hits primary endpoint in wet AMD studies

Roche’s investigational bispecific antibody faricimab has hit the primary endpoint in two Phase III studies in people living with neovascular or wet age-related macular degeneration (nAMD).

In the identically designed studies – TENAYA and LUCERNE – faricimab, administered via injections at fixed intervals, met the primary endpoint, showing that people receiving the treatment achieved visual acuity outcomes that were non-inferior to those receiving Regeneron’s Eylea (aflibercept) injections every eight weeks.

Within both studies, nearly half (45%) of participants were treated with faricimab every 16 weeks during the first year.

“These results show the potential of faricimab as a new class of medicine that could extend time between treatments for people living with neovascular age-related macular degeneration,” said Levi Garraway, chief medical officer and head of Global Product Development, Roche.

“We have now seen positive and consistent results in four Phase III studies for faricimab across both neovascular age-related macular degeneration and diabetic macular edema,” he added.

nAMD impacts around 1.1 million in the US alone, and is the leading cause of blindness in people aged 60 years and older.

According to Roche, it has been over 15 years since a medicine with a new mechanism of action has been approved to treat nAMD, with faricimab being the first bispecific antibody designed for the eye.