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Bispecific Antibody Provides Visual Benefit to Patients With nAMD
Intravitreal faricimab up to every 16 weeks proved noninferior to aflibercept in two phase III trials of patients with neovascular age-related macular degeneration (AMD). Researchers reported their findings in The Lancet.
“Visual benefits with faricimab given at up to 16-week intervals demonstrates its potential to meaningfully extend the time between treatments with sustained efficacy,” researchers reported, “thereby reducing treatment burden in patients with neovascular AMD.”
A bispecific antibody, faricimab acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. The TENAYA and LUCERNE trials tested its effect in a total 1329 treatment-naïve patients with neovascular AMD. Participants were randomly assigned 1:1 to intravitreal faricimab 6.0 mg up to every 16 weeks or aflibercept 2.0 mg every 8 weeks. The trials took place at 271 sites worldwide in 2019, and patients, investigators, and funder F. Hoffmann-La Roche were masked to group assignments.
The primary endpoint of the studies was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48. The prespecified noninferiority margin was four letters.
Faricimab demonstrated noninferiority to aflibercept in both trials, according to the study. Adjusted mean BCVA change with faricimab in TENAYA was 5.8 letters with faricimab and 5.1 letters with aflibercept. In LUCERNE, adjusted mean change was 6.6 letters with faricimab and 6.6 letters with aflibercept.
Ocular adverse event rates were comparable between treatments: 36.3% with faricimab and 38.1% with aflibercept in TENAYA, and 40.2% with faricimab and 36.2% with aflibercept in LUCERNE, researchers reported.
Reference:
Heier JS, Khanani AM, Quezada Ruiz C, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. The Lancet. 2022;399(10326):729-740.
