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  • Faricimab appears noninferior to aflibercept for improving BCVA in wet AMD

    Retina/Vitreous

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    Review of: 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

    Heier J, Khanani A, Quezada Ruiz C, et al. The Lancet, in press

    Faricimab, a bispecific antibody which inhibits both vascular endothelial growth factor A and angiopoietin-2, was approved by the US Food and Drug Administration in late January 2022 for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). This approval was partially based on data from the two phase 3 TENAYA and LUCERNE nAMD studies.

    Study design

    TENAYA and LUCERNE were parallel, randomized, double-masked, noninferiority trials comparing the efficacy of faricimab with aflibercept in patients with nAMD. In total, 1329 treatment-naïve patients aged ≥50 years were enrolled in the studies. Patients were assigned 1:1 to receive intravitreal faricimab 6 mg up to every 16 weeks or aflibercept 2 mg every 8 weeks. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline, averaged over the measurements taken at weeks 40, 44, and 48.

    Outcomes

    In both trials, faricimab was noninferior to aflibercept for mean change in BCVA during the study periods. The incidence of serious ocular adverse events in the study eye was low, and complication rates were comparable between the faricimab and aflibercept groups.

    Limitations

    The major limitation of this study is that the comparator arm consisted of every-8-week aflibercept injections without any opportunity for further extension of treatment intervals, as was seen in the faricimab group. This prevents us from fully understanding the durability benefit gained by faricimab vs. aflibercept. Another limitation is the relatively short 1-year follow-up period for nAMD at the time of the primary analysis.

    Clinical significance

    Faricimab given at up to 16-week intervals has beneficial visual effects in patients with nAMD, and the TENAYA and LUCERNE results show its potential to extend the time between treatments with sustained efficacy, potentially reducing treatment burden. Additional long-term data on the effects of faricimab inhibition are needed to confirm these findings.