Trials Show Promise for Intravitreal Faricimab in Retinal Disease

WEDNESDAY, Feb. 2, 2022 (HealthDay News) -- Faricimab is noninferior to aflibercept for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema, according to two studies published online Jan. 24 in The Lancet.

Jeffrey S. Heier, M.D., from Ophthalmic Consultants of Boston, and colleagues reported the primary results of two phase 3 trials assessing intravitreal faricimab for nAMD. Treatment-naive patients with nAMD aged 50 years or older were randomly assigned to intravitreal faricimab up to every 16 weeks or aflibercept every eight weeks. A total of 1,329 patients were randomly assigned: 334 to faricimab and 337 to aflibercept in the TENAYA trial and 331 and 327, respectively, in the LUCERNE trial. The researchers found that the best-corrected visual acuity change from baseline was noninferior for faricimab versus aflibercept in both TENAYA and LUCERNE.

Charles C. Wykoff, M.D., from Houston Methodist Hospital in Texas, and colleagues presented one-year results from two phase 3 trials involving adults with vision loss due to diabetic macular edema who were randomly assigned to intravitreal faricimab 6.0 mg every eight weeks, faricimab 6.0 mg per personalized treatment interval (PTI), or aflibercept every eight weeks up to week 100. Based on disease activity at active dosing visits, PTI dosing intervals were extended, maintained, or reduced. A total of 1,891 patients were enrolled into the YOSEMITE and RHINE trials and were randomly assigned to faricimab every eight weeks (315 and 317 patients), faricimab PTI (313 and 319 patients), or aflibercept (312 and 315 patients). The researchers found that noninferiority for the primary end point of mean change in best-corrected visual acuity at one year was achieved with faricimab every eight weeks and faricimab PTI.

"These trials present a promising step forward for the millions of patients reliant on vision-preserving anti-vascular endothelial growth factor medications," write the authors of an accompanying editorial.

F. Hoffmann-La Roche funded the studies. Faricimab is manufactured by Genentech, a subsidiary of F. Hoffmann-La Roche.

Abstract/Full Text - Heier (subscription or payment may be required)

Abstract/Full Text - Wykoff (subscription or payment may be required)

Editorial (subscription or payment may be required)