Early Macular Leakage Resolution Is Associated with Extended Faricimab Dosing in Retinal Vein Occlusion: A BALATON/COMINO Post Hoc Analysis.

INTRODUCTION: Macular leakage (ML) is a biomarker of disease activity and, in retinal vein occlusion (RVO), is associated with poor vision outcomes. Faricimab, a dual angiopoietin-2 (Ang-2)/vascular endothelial growth factor (VEGF)-A inhibitor, has demonstrated efficacy and durability in RVO. This post hoc analysis of BALATON/COMINO examined the association between week 24 ML resolution and extended faricimab dosing intervals and vision outcomes achieved at week 68 in patients with RVO. METHODS: BALATON and COMINO (NCT04740905/NCT04740931) were identically designed, phase 3, randomized trials that evaluated the efficacy and safety of faricimab in patients with branch or central/hemiretinal RVO, respectively. Patients initially received faricimab 6 mg every 4 weeks (Q4W) or aflibercept 2 mg Q4W; then from weeks 24-72, all patients received faricimab 6 mg up to Q16W according to a modified treat-and-extend regimen. This analysis included patients who remained in the study at week 68 and had a fluorescein angiography ML reading at week 24. RESULTS: Among 989 patients, 502 had ML resolution (≤ 1 mm2) and 143 had high ML (≥ 10 mm2) at week 24. The proportion of patients who achieved ≥ Q12W faricimab dosing at week 68 was higher among those with ML resolution at week 24 versus those with high ML at week 24 (56.1% vs 38.0%, p = 0.0001). The odds of patients receiving ≥ Q12W faricimab dosing at week 68 were higher among those with ML resolution than among those with high ML at week 24 (odds ratio 2.46, p < 0.001). Patients with ML resolution experienced greater vision gains at week 68 versus patients with high ML at week 24 (18.8 vs 15.0 letters, p = 0.0036). CONCLUSIONS: ML resolution at week 24 was associated with extended faricimab dosing intervals and improved vision at week 68 in patients with RVO in the BALATON/COMINO clinical trials. GOV IDENTIFIERS: NCT04740905, NCT04740931.