Danzig Carl J, Dinah Christiana, Ghanchi Faruque, Hattenbach Lars-Olof, Khanani Arshad M, Lai Timothy Y Y, Shimura Masahiko, Abreu Francis, Arrisi Pablo, Liu Ying, Paris Liliana P, Retiere Anne-Cecile, Willis Jeffrey R, Schlottmann Patricio G
Rand Eye Institute, Deerfield Beach, Florida; Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Florida.
Ophthalmology Department, London North West University Healthcare NHS Trust, Central Middlesex Hospital, London, United Kingdom; Department of Brain Sciences, Imperial College, London, United Kingdom.
Ophthalmol Retina. 2025 Mar 17. doi: 10.1016/j.oret.2025.03.005.
To assess the efficacy, durability, and safety of dual angiopoietin-2/VEGF inhibition with faricimab dosed per a modified treat-and-extend-based regimen in patients with retinal vein occlusion.
Single-arm treatment period after a randomized, double-masked, active comparator-controlled period in the phase III BALATON/COMINO (NCT04740905/NCT04740931) trials.
Patients with treatment-naïve foveal center-involved macular edema due to branch (BALATON; N = 553) or central/hemiretinal (COMINO; N = 729) retinal vein occlusion.
Patients randomized to faricimab 6.0 mg every 4 weeks (Q4W) or aflibercept 2.0 mg Q4W up to week 20 received faricimab 6.0 mg dosed per a modified treat-and-extend-based regimen from week 24 to 72. The dosing frequency was adjusted from Q4W to Q16W based on changes in central subfield thickness (CST) and best-corrected visual acuity.
Change from baseline through week 72 in best-corrected visual acuity and CST; durability and safety through week 72.
Visual acuity gains and CST reductions achieved at week 24 were maintained through week 72. Adjusted mean best-corrected visual acuity (95.03% confidence interval [CI]) changes from baseline averaged over weeks 64, 68, and 72 in the prior faricimab Q4W and prior aflibercept Q4W arms were +18.1 letters (16.9-19.4) and +18.8 letters (17.5-20.0), respectively, in BALATON and +16.9 letters (15.2-18.6) and +17.1 letters (15.4-18.8), respectively, in COMINO. Adjusted mean (95.03% CI) CST changes from baseline averaged over weeks 64, 68, and 72 in the prior faricimab Q4W and prior aflibercept Q4W arms were -310.9 μm (-315.6 to -306.3) and -307.0 μm (-311.7 to -302.3), respectively, in BALATON and -465.9 μm (-472.5 to -459.3) and -460.6 μm (-467.2 to -453.9), respectively, in COMINO. In the prior faricimab Q4W and prior aflibercept Q4W arms, 64.1% and 56.9% of patients from BALATON and 45.5% and 50.1% from COMINO, respectively, were on ≥Q12W dosing at week 68. Faricimab continued to be well tolerated from weeks 24 to 72; the safety profile was consistent with that established for diabetic macular edema and neovascular age-related macular degeneration.
These findings support the sustained efficacy and safety of faricimab in patients with macular edema due to retinal vein occlusion up to 72 weeks, with the potential for reduced treatment burden due to response durability.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
评估在视网膜静脉阻塞患者中，按照改良的基于治疗并延长的方案给药的faricimab双重抑制血管生成素-2/血管内皮生长因子（VEGF）的疗效、持久性和安全性。
在III期BALATON/COMINO（NCT04740905/NCT04740931）试验中，经过随机、双盲、活性对照药对照期后的单臂治疗期。
因分支视网膜静脉阻塞（BALATON研究；N = 553）或中心/半侧视网膜静脉阻塞（COMINO研究；N = 729）而初治且累及黄斑中心凹的黄斑水肿患者。
随机分配至每4周接受6.0 mg faricimab或每4周接受2.0 mg阿柏西普治疗直至第20周的患者，在第24周至72周按照改良的基于治疗并延长的方案接受6.0 mg faricimab治疗。给药频率根据中心子野厚度（CST）和最佳矫正视力的变化从每4周一次调整为每16周一次。
从基线至第72周最佳矫正视力和CST的变化；至第72周的持久性和安全性。
在第24周时实现的视力提高和CST降低在第72周时得以维持。在BALATON研究中，先前接受每4周一次faricimab治疗组和先前接受每4周一次阿柏西普治疗组在第64、68和72周时从基线调整后的平均最佳矫正视力（95.03%置信区间[CI]）变化分别为+18.1字母（16.9 - 19.4）和+18.8字母（17.5 - 20.0）；在COMINO研究中分别为+16.9字母（15.2 - 18.6）和+17.1字母（15.4 - 18.8）。在BALATON研究中，先前接受每4周一次faricimab治疗组和先前接受每4周一次阿柏西普治疗组在第64、68和72周时从基线调整后的平均（95.03% CI）CST变化分别为-310.9 µm（-315.6至-306.3）和-307.0 µm（-311.7至-302.3）；在COMINO研究中分别为-465.9 µm（-472.5至-459.3）和-460.6 µm（-467.2至-453.9）。在先前接受每4周一次faricimab治疗组和先前接受每4周一次阿柏西普治疗组中，BALATON研究分别有64.1%和56.9%的患者以及COMINO研究分别有45.5%和50.1%的患者在第68周时接受≥每12周一次的给药。从第24周至72周，faricimab的耐受性持续良好；安全性特征与糖尿病性黄斑水肿和新生血管性年龄相关性黄斑变性所确立的一致。
这些发现支持faricimab在视网膜静脉阻塞所致黄斑水肿患者中长达72周的持续疗效和安全性，且由于反应持久性有减轻治疗负担的潜力。
在本文末尾的脚注和披露内容中可能会有专有或商业披露信息。
