Faricimab Under Review for Macular Edema Following Retinal Vein Occlusion

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.