黄斑水肿患者的福音!罗氏(Roche)眼疾药 faricimab 两大临床试验达主要评估指标

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制药巨擘罗氏药厂(Roche)于日前公布了两项全球第 3 期临床试验研究 BALATON、COMINO的最新结果。该临床试验是用于评估双特异性抗体(bispecific antibody)药物 Vabysmo(faricimab)于治疗视网膜中央与分支静脉阻塞(BRVO、CRVO)的黄斑水肿(macular edema)。

影响全球数千万人视力的视网膜静脉阻塞

视网膜静脉阻塞(retinal vein occulsion, RVO)为导致视力丧失的第二大主因,全球受此疾困扰的患者高达约 2800 万,并常见于 60 岁(含)以上的长者。RVO 与血管生成素-2(Angiopoietin-2, Ang-2)值升高有关,因静脉阻塞会限制视网膜的正常血流,产生缺血、出血、液体渗漏、黄斑水肿导致的视网膜肿胀,可能会导致严重、突然、无痛的视力丧失。目前研究认为 Ang-2 的表现提升会推动该疾病进程。

罗氏眼疾药 faricimab

Faricimab 为罗氏药厂旗下子公司 Genentech 所研发的眼疾用药,是第一个、也是目前唯一一个获准用于治疗眼疾的双特异性抗体。其药物机制为透过标靶抑制两种会危害视力的蛋白相关路径,分别为血管生成素-2 (Angiopoietin-2, Ang-2)和血管内皮生长因子-A(vascular endothelial growth factor-A, VEGF-A),借此回复因血管渗漏所导致的发炎症状。

目前 faricimab 已在全球 40 多国获得核准,可用于治疗湿性老年黄斑部病变(wet Age-related macular degeneration, AMD)和糖尿病黄斑部糖尿病黄斑水肿(Diabetic Macular Edema, DME)所导致的视力丧失情形,核准国家包含美国、日本、英国及欧盟等。

为了此药,罗氏已制定了多项研究计画,包含 3 期临床试验 AVONELLE-X、TENAYA 及 LUCERNE 的延长试验,以评估该药于新生血管或湿性老年黄斑部病变治疗的长期安全性与耐受性。另外,罗氏还为糖尿病黄斑水肿患者启动第 4 期临床试验 ElevatUM 及其他独立研究,以近一步了解其他尚未满足的医疗需求。

两大临床试验皆达到主要评估指标

根据罗氏的新闻稿指出,BALATON、COMINO 两大临床试验皆达到主要试验终点,显示无论是 BRVO 或 CRVO 引起的黄斑水肿患者,在每 4 周接受 faricimab 的注射治疗长达 24 周后,与注射黄斑病变常用疗法 aflibercept 的患者相比,其视力获得改善。此外,在接受 faricimab 治疗 24 周后,也展现了视网膜液体速干的疗效。而两项研究也皆指出该药的耐受性普遍良好,安全性与先前的试验结果一致。

罗氏药厂指出,详细数据结果将于近期医学会议上公布,并也会提交给世界各国的监管机关。

延伸阅读:罗氏(Roche)黄斑病变药 faricimab 治盲有效!可改善并维持视力

参考资料:
1. https://www.roche.com/media/releases/med-cor-2022-10-27

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