BASEL, Switzerland—Roche's global Phase 3 studies, TENAYA and LUCERNE, presented the company—and those living with neovascular or “wet” age-related macular degeneration (nAMD)—with good news this week. Both studies met their primary endpoint, demonstrating that participants who received faricimab injections at fixed intervals of up to every 16 weeks reached visual acuity outcomes that were non-inferior to those who received aflibercept injections every eight weeks. Forty-five percent of participants in both studies were treated with faricimab every 16 weeks during the first year, and according to Roche, this is is the first time such a level of durability has been achieved in a Phase 3 study of an injectable eye medicine for nAMD.
TENAYA and LUCERNE are identically designed, randomized, double-masked studies assessing the safety and efficacy of faricimab compared to aflibercept in 1,329 people with nAMD. The primary endpoint for the studies is the average change in best-corrected visual acuity score (BCVA)—the best distance vision a person can achieve, with or without correction like 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.
“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 Dr. Levi Garraway, Roche’s chief medical officer and head of Global Product Development. “We have now seen positive and consistent results in four Phase 3 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.”
Approximately 20 million people are affected by nAMD worldwide, and while the current standard of care—anti-VEGF (vascular endothelial growth factor) injections—has reduced vision loss caused by nAMD, it is not foolproof. Patients can need injections as often as once a month to maintain acuity or prevent further vision loss, and the last medicine with a new mechanism of action for treating this condition was approved more than 15 years ago, according to a Roche press release.
Faricimab is the first investigational bispecific antibody designed for the eye. The drug candidate targets two pathways—angiopoietin-2 and vascular endothelial growth factor-A—and by doing so, stabilizes blood vessels and mitigates vision loss. Faricimab was generally well tolerated in both TENAYA and LUCERNE, with no new or unexpected safety signals.
These results come on the heels of additional positive top-line results for faricimab. Roche shared news in December of data from its Phase 3 YOSEMITE and RHINE studies of faricimab in people with diabetic macular edema. The company intends to present the results from all four studies 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.