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 two studies (n=1329) found faricimab (6.0mg up to every 16 weeks) was non-inferior to aflibercept (2.0mg every 8 weeks) for best-corrected visual acuity change from baseline (adjusted mean change of 5.8 letters v 5.1 letters in TENAYA and 6.6 v 6.6 letters in LUCERNE).
Source:
The Lancet
SPS commentary:
Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. A related comment notes the faricimab group achieved dosing intervals of 12 weeks or more in approximately 80% of patients and 16 weeks in approximately 45%.
The results of two non-inferiority studies of faricimab in diabetic macular oedema, again in comparison to aflibercept, have also been published. In all studies, there was a high rate of major protocol deviations, in part driven by the pandemic; other limitations include the absence of a comprehensive published protocol and the industry-funded nature of the trials. The authors of the comment say further research is needed; 2-year results from all four studies will provide longer-term safety and durability data. Although pivotal aflibercept studies evaluated a fixed dose, most specialists favour a variable regimen, and it is not known how faricimab would compare with variably dosed aflibercept.