Faricimab for previously-treated eyes with neovascular age-related macular degeneration with inadequate response - 6-month interim analysis of the FURGGHORN study.

PURPOSE: To investigate the effect of switching to faricimab therapy patients with neovascular age-related macular degeneration currently treated with anti-VEGF therapy.

DESIGN

Phase IV, prospective, single-arm, open-label, multi-center, investigator-initiated clinical trial.

METHODS

Eligible eyes received four initial doses of faricimab 6 mg/0.05 mL every 4-weeks. From week 12, dosing intervals were increased to eight weeks and then modified according to a treat-and-extend based regimen. This interim analysis reports changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), retinal fluid proportions, and the incidence of adverse events from baseline through to week 24.

RESULTS

One-hundred-and-two patients of mean age 76.0 years were recruited from 12 sites across Australia and Singapore. Baseline BCVA was 72 Early Treatment Diabetic Retinopathy Study letters and baseline CST was 384 µm. Seventy-two percent of eyes were being treated with aflibercept 2 mg and 28% with ranibizumab. After switching to faricimab, mean BCVA change was + 1.9 letters at week 12 (P < 0.001), and + 1.9 letters at week 24 (P < 0.001). Mean CST change was -83.9 µm at week 12 (P < 0.001), and -82.2 µm at week 24 (P < 0.001). The proportion of eyes with fluid resolution was 54% at week 12, and 59% at week 24. The proportion of eyes assigned to 4-weekly, 8-weekly, and 12-weekly treatment intervals were 16%, 35% and 49% respectively at week 24. Anterior chamber inflammation occurred in one eye with no cases of vasculitis or occlusive retinitis.

CONCLUSIONS

In this pre-specified interim analysis of a prospective study, patients switching to faricimab experienced improved anatomic outcomes and maintained visual function, with a large proportion assigned extended dosing intervals under a flexible treatment regimen.

TRIAL REGISTRATION NUMBER: ACTRN12623000215628.