Clinical design trial assesses faricimab in neovascular AMD
In 2 ongoing phase 3 trials, researchers are assessing the efficacy, safety, and durability of faricimab compared with aflibercept in patients with neovascular age-related macular degeneration (nAMD). The clinical study design was presented at ARVO 2021.
The TENAYA and LUCERNE trials are randomized, double-masked, active comparator–controlled, 112-week studies of faricimab, the first bispecific antibody designed for intraocular use, in nAMD. Treatment-naïve patients are randomized 1:1 to faricimab 6.0 mg up to every 16 weeks (Q16W) after 4 initial every-4-week (Q4W) doses or aflibercept 2.0 mg every 8 weeks (Q8W) after 3 initial Q4W doses. According to disease activity assessments at weeks 20, patients in the faricimab arm will receive Q8W, every-12-week (Q12W), or Q16W dosing until week 60. Faricimab-treated patients also will receive personalized treatment interval (PTI), a treat-and-extend regimen with interval adjustment based on treatment response as assessed by prespecified anatomical and functional criteria at study drug dosing visits, up to week 108. The PTI phase is designed to reduce treatment burden while optimizing outcomes, the researchers noted.
The primary efficacy endpoint is change in best-corrected visual acuity from baseline averaged over weeks 40, 44, and 48. Secondary endpoints include the proportion of patients receiving faricimab Q16W, Q12W, and Q8W, and changes in anatomic outcomes as well as safety outcomes such as the incidence and severity of adverse events.
Guymer RH, et al. Dual angiopoietin-2 and VEGF-A inhibition with faricimab in neovascular age-related macular degeneration: phase 3 TENAYA and LUCERNE trial design. Presented at ARVO 2021.