Lariboisière and Fondation Adolphe de Rothschild Hospitals, Université Paris Cité, Paris, France.
Genentech, Inc., South San Francisco, California.
Ophthalmology. 2024 Aug;131(8):950-960. doi: 10.1016/j.ophtha.2024.01.029. Epub 2024 Jan 26.
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 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], 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.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
评估双重血管生成素-2（Ang-2）和血管内皮生长因子（VEGF-A）抑制剂 faricimab 与 aflibercept 治疗静脉闭塞性疾病患者 24 周的疗效和安全性。
全球、随机、双盲、阳性对照对照的 3 期临床试验：BALATON/COMINO（ClincalTrials.gov 标识符：NCT04740905/NCT04740931；地点：149/192）。
未经治疗的中心性黄斑水肿患者，累及分支（BALATON）或中央或半视网膜静脉阻塞（COMINO）。
患者按 1:1 随机分为 faricimab 6.0mg 或 aflibercept 2.0mg 每 4 周一次，共 24 周。
从基线到 24 周最佳矫正视力（BCVA）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至少 1 剂研究药物的患者。
入组：BALATON，n=553；COMINO，n=729。与 aflibercept 相比，faricimab 从基线到 24 周的 BCVA 增益在 BALATON 中具有非劣效性（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]）。在 BALATON 中，faricimab 和 aflibercept 在第 24 周时中央视网膜下厚度的平均降低从基线开始是可比的（-311.4μm[95.03%CI，-316.4 至-306.4μm]和-304.4μm[95.03%CI，-309.3 至-299.4μm]）和 COMINO（-461.6μm[95.03%CI，-471.4 至-451.9μm]和-448.8μm[95.03%CI，-458.6 至-439.0μm]）。与 aflibercept 相比，faricimab 组有更多的患者在第 24 周时达到无荧光素血管造影黄斑渗漏（33.6% vs. 21.0%；名义 P=0.0023）和 COMINO（44.4% vs. 30.0%；名义 P=0.0002）。Faricimab 耐受性良好，安全性与 aflibercept 相当。接受 faricimab 治疗的患者（BALATON 和 COMINO 分别为 16.3%[n=45]和 23.0%[n=84]）和 aflibercept（20.4%[n=56]和 27.7%[n=100]）的眼部不良事件发生率相似。
这些发现表明双重 Ang-2/VEGF-A 抑制剂 faricimab 在视网膜静脉闭塞性疾病引起的黄斑水肿患者中具有疗效和安全性。
本文末尾的脚注和披露可能包含专有或商业披露。
