OCT 13, 2020
This phase 2 trial assessed extended dosing of faricimab compared with monthly ranibizumab for neovascular AMD.
Researchers conducted a randomized, multicenter, active comparator-controlled, parallel-group study over a 52-week period. Seventy-six patients were randomized 2:2:1 to receive either a 6-mg dose of faricimab every 16 or 12 weeks or a 0.5-mg dose of ranibizumab every 4 weeks; the faricimab arms initially received 4 monthly doses. A disease activity assessment was performed at week 24. The primary endpoint was mean change in BCVA at week 40.
At week 24, 65% (36/55) of patients in the faricimab arms showed no disease activity. By week 40, the patients in the 2 faricimab groups achieved comparable visual acuity gains to the ranibizumab arm. Spectral-domain OCT and fluorescein angiography at weeks 40 and 52 revealed comparable reductions in central subfield thickness and lesion size in all 3 groups. There were no new or unexpected safety events during the trial.
This was a phase 2 study with a limited sample size (76 randomized patients) and a relatively short duration (52 weeks).
Faricimab has the potential to address an unmet need and reduce treatment burden among patients who show a decline in number of AMD treatment injections over time in the real world. Phase 3 trials are ongoing to further evaluate the efficacy, durability and safety of faricimab.