Positive faricimab data for wet AMD, DME, studies find

Positive one-year results of Genentech’s phase III trials analyzing faricimab for treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME) were released today.

Published in The Lancet, the two papers highlight four studies in which approximately half of more than 3,000 eligible participants were able to go four months between treatments, while an estimated three-fourths were treated every three months or longer, according to a Genetech news release.

With the potential to be the first investigational bispecific antibody for the eye, faricimab is designed to target and inhibit two pathways linked to several retinal conditions by angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).

The four trials included TENAYA and LUCERNE for wet AMD as well as YOSEMITE and RHINE for DME.

In the TENAYA and LUCERNE trials, the average vision gains from baseline at one year in the faricimab arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the aflibercept arms, the study reported.

To note, 46% of patients in the TENAYA trial and 45% of patients in the LUCERNE trial were able to be treated every four months, while an additional 34% in the TENAYA and 33% in the LUCERNE were able to be treated every four months. Together, nearly 80% of treated patients were able to go three-plus months between treatments by the end of the first year.

As consistent with vision outcomes, the treatment resulted in a meaningful and comparable reduction in central subfield thickness (CST), with comparable decreases in choroidal neovascularization lesions size and area, the release stated.

In the YOSEMITE and RHINE trials, average vision gains from baseline at one year were +11.6 and +10.8 eye chart letters in the faricimab treat-and-extend arms, +10.7 and +11.8 letters in the two-month arms, and +10.9 and +10.3 letters in the aflibercept arms, respectively, according to the company.

To note, 53% of treated patients in the YOSEMITE trial and 51% in the RHINE trial were able to be dosed every four months, while 21% (YOSEMITE) and 20% (RHINE) achieved three-month dosing.

In total, 70% of patients in the YOSEMITE and RHINE trials were able to go three months or longer in between treatments. Further, CST reductions and resolution of intraretinal fluid consistently favored faricimab over aflibercept by the end of the first year.

The FDA is currently reviewing faricimab for the treatment of wet AMD and DME.

Two-year results for faricimab in DME will be presented next month at the Angiogenesis, Exudation, and Degeneration 2022 meeting.