Faricimab in Neovascular Age-Related Macular Degeneration: 1-Year Efficacy, Safety, and Durability in the Phase 3 TENAYA and LUCERNE Trials

Abstract

Purpose : Dual inhibition of angiopoietin-2 and vascular endothelial growth factor-A with faricimab, a bispecific antibody designed for intraocular use, may promote vascular stability with sustained efficacy through extended durability in patients with neovascular age-related macular degeneration (nAMD). Here we report primary 1-year results of the ongoing phase 3 TENAYA and LUCERNE trials, comparing efficacy, safety, and durability of faricimab with aflibercept in patients with nAMD.

Methods : TENAYA (NCT03823287) and LUCERNE (NCT03823300) are identical, phase 3, randomized, double-masked, active comparator–controlled, 112-week studies of faricimab in nAMD. Treatment-naïve patients were randomized 1:1 to receive faricimab 6.0 mg up to every 16 weeks (Q16W) or aflibercept 2.0 mg every 8 weeks (Q8W). Patients in the faricimab arm received 4 initial every-4-week (Q4W) doses and were assessed for protocol-defined disease activity at weeks 20 and 24. Patients with no evidence of active disease at weeks 20 and 24 received Q16W dosing through week 60; those with active disease at week 20 received Q8W dosing; patients with active disease only at week 24 received every-12-week (Q12W) dosing. From week 60, faricimab-treated patients follow a personalized treatment interval based on a protocol-driven treat-and-extend regimen through week 108. Patients randomized to aflibercept received 3 initial Q4W doses and then Q8W dosing through week 108. Efficacy and safety outcomes were assessed at Q4W study visits. The primary efficacy endpoint is mean change in best-corrected visual acuity from baseline averaged over weeks 40, 44, and 48. Secondary endpoints include the proportion of patients on faricimab Q16W, Q12W, and Q8W regimens; proportion of patients gaining ≥15 or ≥10 ETDRS letters from baseline; and changes from baseline in anatomic outcomes. Safety outcomes include incidence and severity of ocular and nonocular adverse events.

Results : In phase 2 studies, faricimab at up to Q16W dosing intervals was associated with robust vision and anatomic improvements, comparable with ranibizumab Q4W. TENAYA and LUCERNE are ongoing global phase 3 trials; year 1 study results will be presented at the meeting.

Conclusions : TENAYA and LUCERNE phase 3 trials are evaluating efficacy, safety, and extended durability up to Q16W of intravitreal faricimab in patients with nAMD.

This is a 2021 ARVO Annual Meeting abstract.