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Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): Two randomized, double-masked, phase 3, non-inferiority trials

The Lancet Jan 27, 2022

The action of faricimab, a bispecific antibody, involves dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. In this work, the primary results of two phase 3 trials (TENAYA and LUCERNE) investigating intravitreal faricimab with extension up to every 16 weeks for neovascular age-related macular degeneration (nAMD), are reported.

  • Across the two trials, 1,329 treatment-naïve patients with nAMD aged 50 years or older were randomly assigned to intravitreal faricimab 6·0 mg up to every 16 weeks, based on protocol-defined disease activity assessments at weeks 20 and 24, or aflibercept 2·0 mg every 8 weeks.

  • Non-inferior BCVA change was recorded from baseline with faricimab vs aflibercept in both TENAYA (adjusted mean change 5·8 letters [95% CI 4·6 to 7·1] and 5·1 letters [3·9 to 6·4]; treatment difference 0·7 letters [−1·1 to 2·5]) and LUCERNE (6·6 letters [5·3 to 7·8] and 6·6 letters [5·3 to 7·8]; treatment difference 0·0 letters [–1·7 to 1·8]).

  • Faricimab given at up to 16-week intervals was linked with visual benefits demonstrating its potential to meaningfully extend the time between treatments with sustained efficacy, thereby lowering treatment burden in patients with nAMD.

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