Roche has 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 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.
Faricimab is the first bispecific antibody designed for the eye.1 It targets two distinct pathways – via angiopoietin-2 (Ang-2) and VEGF-A – that drive a number of retinal conditions, including nAMD.1
“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., Roche’s 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.”
- Khan M, et al. Targeting Angiopoietin in retinal vascular diseases: A literature review and summary of clinical trials involving faricimab. Cells. 2020;9:1869.