Faricimab Under Review for Macular Edema Following Retinal Vein Occlusion

The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for faricimab-svoa for the treatment of macular edema following retinal vein occlusion (RVO).

The sBLA is supported by data from the randomized, multicenter, double-masked phase 3 BALATON (ClinicalTrials.gov Identifier: NCT04740905) and COMINO (ClinicalTrials.gov Identifier: NCT04740931) studies, which included 553 patients with macular edema due to branch RVO and 729 patients with macular edema secondary to central retinal or hemiretinal vein occlusion, respectively. Patients were randomly assigned 1:1 to receive 6 monthly injections of either faricimab 6mg or aflibercept 2mg for 20 weeks; from weeks 24 to 72, all patients received faricimab 6mg up to every 4 months. 

The primary endpoint was the change in best-corrected visual acuity (BCVA) from baseline at 24 weeks. In both studies, faricimab was found to be noninferior to aflibercept, with average vision gains being comparable between the treatment groups (BALATON: +16.9 letters with faricimab vs +17.5 letters with aflibercept; COMINO: +16.9 letters with faricimab vs +17.3 letters with aflibercept). 

Faricimab was also associated with rapid reductions in central subfield thickness (secondary endpoint). Moreover, a greater proportion of patients in the faricimab arm had an absence of blood vessel leakage in the retina compared with those in the aflibercept arm (exploratory endpoint).

The safety profile of faricimab was consistent with that observed in previous studies. The most common adverse reaction reported was conjunctival hemorrhage (3%).

Faricimab, an inhibitor of vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), is currently marketed under the brand name Vabysmo for the treatment of patients with wet, or neovascular, age-related macular degeneration and diabetic macular edema.