To evaluate the 24-week efficacy and safety of the dual angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF)-A inhibitor faricimab versus aflibercept in patients with vein occlusion. Phase 3, global, randomized, double-masked, active comparator-controlled trials: BALATON/COMINO (ClincalTrials.gov identifiers: NCT04740905/NCT04740931; sites: 149/192). Patients with treatment-naïve foveal center-involved macular edema resulting from branch (BALATON) or central or hemiretinal (COMINO) RVO. Patients were randomized 1:1 to faricimab 6.0 mg or aflibercept 2.0 mg every 4 weeks for 24 weeks. Primary end point: change in best-corrected visual acuity (BCVA) from baseline to week 24. Efficacy analyses included patients in the intention-to-treat population. Safety analyses included patients who received ≥ 1 doses of study drug. Enrollment: BALATON, n = 553; COMINO, n = 729. The BCVA gains from the baseline to week 24 with faricimab were noninferior versus aflibercept in BALATON (adjusted mean change, +16.9 letters [95.03% confidence interval (CI), 15.7–18.1 letters] vs. +17.5 letters [95.03% CI, 16.3–18.6 letters]) and COMINO (+16.9 letters [95.03% CI, 15.4–18.3 letters] vs. +17.3 letters [95.03% CI, 15.9–18.8 letters]). Adjusted mean central subfield thickness reductions from the baseline were comparable for faricimab and aflibercept at week 24 in BALATON (−311.4 μm [95.03% CI, −316.4 to −306.4 μm] and −304.4 μm [95.03% CI, −309.3 to −299.4 μm]) and COMINO (−461.6 μm [95.03% CI, −471.4 to −451.9 μm] and −448.8 μm [95.03% CI, −458.6 to −439.0 μm]). A greater proportion of patients in the faricimab versus aflibercept arm achieved absence of fluorescein angiography-based macular leakage at week 24 in BALATON (33.6% vs. 21.0%; nominal = 0.0023) and COMINO (44.4% vs. 30.0%; nominal = 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], respectively). These findings demonstrate the efficacy and safety of faricimab, a dual Ang-2/VEGF-A inhibitor, in patients with macular edema secondary to retinal vein occlusion. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

中文翻译：

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Faricimab 治疗视网膜静脉阻塞引起的黄斑水肿的疗效和安全性：BALATON 和 COMINO 试验的 24 周结果

评估血管生成素 2 (Ang-2) 和血管内皮生长因子 (VEGF)-A 双重抑制剂法瑞昔单抗与阿柏西普治疗静脉闭塞患者的 24 周疗效和安全性。3 期、全球、随机、双盲、主动对照试验：BALATON/COMINO（ClincalTrials.gov 标识符：NCT04740905/NCT04740931；地点：149/192）。因分支 (BALATON) 或中央或半视网膜 (COMINO) RVO 导致未接受治疗的黄斑中心凹中心黄斑水肿的患者。患者按 1:1 的比例随机分配至 Faricimab 6.0 mg 或阿柏西普 2.0 mg，每 4 周一次，持续 24 周。主要终点：最佳矫正视力 (BCVA) 从基线到第 24 周的变化。疗效分析包括意向治疗人群中的患者。安全性分析包括接受≥1剂研究药物的患者。入学情况：巴拉顿湖，n = 553；COMINO，n = 729。在 BALATON 中，法里昔单抗从基线到第 24 周的 BCVA 增益不劣于阿柏西普（调整后的平均变化，+16.9 个字母 [95.03% 置信区间 (CI)，15.7-18.1 个字母] vs. +17.5 个字母） [95.03% CI，16.3–18.6 个字母]）和 COMINO（+16.9 个字母[95.03% CI，15.4–18.3 个字母] vs. +17.3 个字母[95.03% CI，15.9–18.8 个字母]）。BALATON 中第 24 周时法瑞昔单抗和阿柏西普的调整后平均中心子区域厚度相对于基线的减少量相当（-311.4 μm [95.03% CI，-316.4 至 -306.4 μm] 和 -304.4 μm [95.03% CI，-309.3 至 -299.4] μm]）和 COMINO（-461.6 μm [95.03% CI，-471.4 至 -451.9 μm] 和 -448.8 μm [95.03% CI，-458.6 至 -439.0 μm]）。与阿柏西普组相比，法里昔单抗组中在第 24 周时，BALATON 组（33.6% 对比 21.0%；名义值 = 0.0023）和 COMINO 组（44.4% 对比 30.0%；名义值 = 0.0002）中没有基于荧光素血管造影的黄斑渗漏的患者比例更高）。Faricimab 的耐受性良好，具有与阿柏西普相当的可接受的安全性。接受 Faricimab 治疗的患者（BALATON 和 COMINO 分别为 16.3% [n = 45] 和 23.0% [n = 84]）和阿柏西普治疗患者（20.4% [n = 56] 和 27.7% [n]）之间眼部不良事件的发生率相似= 100]，分别）。这些研究结果证明了 Faricimab（一种 Ang-2/VEGF-A 双重抑制剂）对于继发于视网膜静脉阻塞的黄斑水肿患者的有效性和安全性。专有或商业披露可在本文末尾的脚注和披露中找到。