Roche’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 - Seite 2

“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. 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.”

The findings from TENAYA and LUCERNE build on positive topline results from the phase III YOSEMITE and RHINE studies, announced in December 2020, which support the potential of faricimab as a treatment option for diabetic macular edema, a leading cause of vision loss among working-age adults.⁹ Detailed results from all four studies will be presented in February at Angiogenesis, Exudation, and Degeneration 2021, a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine, and submitted for approval to health authorities around the world, including the U.S. Food and Drug Administration and European Medicines Agency.

About the TENAYA and LUCERNE studies ^10,11
TENAYA (NCT03823287) and LUCERNE (NCT03823300) are two identical, randomised, multicentre, double-masked, global phase III studies, evaluating the efficacy and safety of faricimab compared to aflibercept in 1,329 people living with neovascular age-related macular degeneration (671 in TENAYA and 658 in LUCERNE). The studies each have two treatment arms: faricimab 6.0 mg administered at fixed intervals of every eight, 12 or 16 weeks, selected based on objective assessment of disease activity at weeks 20 and 24; aflibercept 2.0 mg administered at fixed eight-week intervals. In both arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants.

The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline through week 48. Secondary endpoints include: safety; the percentage of participants in the faricimab arm receiving treatment every eight, 12 and 16 weeks; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; and change in central subfield thickness from baseline over time.