Efficacy and Safety of Faricimab for Macular Edema due to Retinal Vein Occlusion

PurposeTo evaluate the 24-week efficacy and safety of the dual angiopoietin-2 (Ang-2)/vascular endothelial growth factor-A (VEGF-A) inhibitor, faricimab, compared with aflibercept in patients with macular edema due to retinal vein occlusion (RVO).DesignTwo identically designed, phase 3, global, randomized, double-masked, active comparator–controlled trials: BALATON (NCT04740905; N = 149 sites) and COMINO (NCT04740931; N = 192 sites).ParticipantsPatients ≥18 years of age with treatment-naïve foveal center-involved macular edema due to branch (BALATON) or central or hemiretinal (COMINO) RVO.MethodsPatients were randomized 1:1 to faricimab 6.0 mg or aflibercept 2.0 mg every 4 weeks for 24 weeks.Main Outcome MeasuresThe primary end point was the change from baseline in best-corrected visual acuity (BCVA) at week 24. Efficacy analyses included patients in the intention-to-treat population. Safety analyses included patients who received ≥1 dose of study drug.Results553 and 729 patients were enrolled in BALATON and COMINO, respectively. The BCVA gains from baseline at week 24 with faricimab were noninferior to aflibercept in BALATON (adjusted mean [95.03% confidence interval] change: +16.9 letters [15.7, 18.1] vs. +17.5 letters [16.3, 18.6]) and COMINO (+16.9 letters [15.4, 18.3] vs. +17.3 letters [15.9, 18.8]). Adjusted mean (95.03% confidence interval) central subfield thickness reductions from baseline were comparable for faricimab and aflibercept at week 24 in BALATON (−311.4 μm [−316.4, −306.4] and −304.4 μm [−309.3, −299.4]) and COMINO (−461.6 μm [−471.4, −451.9] and −448.8 μm [−458.6, −439.0]). A greater proportion of patients in the faricimab arm versus the aflibercept arm achieved absence of fluorescein angiography-based macular leakage at week 24 in BALATON (33.6% vs. 21.0%; nominal P = 0.0023) and COMINO (44.4% vs. 30.0%; nominal P = 0.0002). Faricimab was well tolerated, with an acceptable safety profile comparable with aflibercept. The incidence of ocular adverse events was similar between patients receiving faricimab (16.3% [n = 45] and 23.0% [n = 84] in BALATON and COMINO, respectively) and aflibercept (20.4% [n = 56] and 27.7% [n = 100]).ConclusionsThese findings demonstrate the efficacy and safety of faricimab, a dual Ang-2/VEGF-A inhibitor, in patients with macular edema secondary to RVO.