Genentech’s Faricimab Meets Primary Endpoint in Two Global Phase III Studies and Shows Potential to Extend Time Between Treatments up to 16 Weeks for People With Neovascular Age-Related Macular Degeneration
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two identically designed global Phase III studies, TENAYA and LUCERNE, evaluating its investigational bispecific antibody, faricimab, in people living with neovascular or “wet” age-related macular degeneration (nAMD). Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving aflibercept injections every eight weeks. Nearly half (45%) of people in both studies were treated with faricimab every 16 weeks during the first year. 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.
Neovascular AMD affects approximately 1.1 million people in the United States. and is the leading cause of blindness in those aged 60 and older. Current standards of care, injections that inhibit vascular endothelial growth factor (VEGF), have significantly reduced the rates of vision loss due to nAMD. However, VEGF is not the only pathway involved in the development and progression of this complex condition. With anti-VEGF monotherapies, people with nAMD have to visit their ophthalmologist as often as monthly for eye injections to help maintain vision gains and/or prevent vision loss. This high treatment burden can lead to under-treatment and potentially less than optimal vision outcomes. It has been more than 15 years since a medicine with a new mechanism of action has been approved to treat nAMD. Faricimab is the first bispecific antibody designed for the eye. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and VEGF-A – that drive a number of retinal conditions, including nAMD.
“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, M.D., Ph.D., chief medical officer and head of Global Product Development. “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. We look forward to submitting these data to global regulatory authorities, with the aim of bringing this promising treatment option to patients as soon as possible.”