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考察法西单抗和高剂量阿柏西普用于湿性年龄相关性黄斑变性和糖尿病性黄斑水肿的临床试验及真实世界研究。

Clinical trials and real-world studies examining faricimab and high-dose aflibercept for wet age-related macular degeneration and diabetic macular edema.

作者信息

Kalavar Meghana, Sridhar Jayanth

机构信息

Havener Eye Institute, Ohio State University Wexner Medical Center, Columbus, Ohio.

Olive View-University of California Los Angeles Medical Center, Sylmar, California, USA.

出版信息

Curr Opin Ophthalmol. 2025 May 1;36(3):189-198. doi: 10.1097/ICU.0000000000001129. Epub 2025 Feb 12.

DOI:10.1097/ICU.0000000000001129
PMID:39937692
Abstract

PURPOSE OF REVIEW

The goal of this review is to summarize emerging clinical trial and real world evidence for faricimab and high dose aflibercept (8 mg), two recently approved treatments for wet age-related macular degeneration and diabetic macular edema.

RECENT FINDINGS

Faricimab, a bispecific monoclonal antibody targeting vascular endothelial growth factor (VEGF) and angiopoietin-2, and high-dose aflibercept have demonstrated significant potential for extending treatment intervals while maintaining efficacy. Pivotal clinical trials such as YOSEMITE, and RHINE established faricimab to be noninferior to standard anti-VEGF therapy with superior durability. Real-world data corroborated these results, demonstrating improved anatomic outcomes with extended treatment intervals, though improvements in best corrected visual acuity (BCVA) remains varied. High-dose aflibercept has similarly demonstrated noninferiority in landmark clinical trials such as PHOTON and PULSAR, with extended dosing intervals. However, comprehensive real-world data for high dose aflibercept remains limited and warrants further investigation.

SUMMARY

Both faricimab and high-dose aflibercept show promise in reducing treatment burden for wet age-related macular degeneration and diabetic macular edema through extended dosing intervals while maintaining or improving clinical outcomes compared to standard anti-VEGF therapy. Faricimab has demonstrated this both in clinical trials as well as real-world studies, while high-dose aflibercept has demonstrated similar durability in trials but requires additional real-world evidence.

摘要

综述目的

本综述的目的是总结法西单抗和高剂量阿柏西普(8毫克)这两种最近获批用于治疗湿性年龄相关性黄斑变性和糖尿病性黄斑水肿的药物的新兴临床试验和真实世界证据。

最新发现

法西单抗是一种靶向血管内皮生长因子(VEGF)和血管生成素-2的双特异性单克隆抗体,高剂量阿柏西普已显示出在延长治疗间隔的同时保持疗效的巨大潜力。关键临床试验,如约塞米蒂试验和莱茵试验,证实法西单抗不劣于标准抗VEGF治疗,且具有更高的耐用性。真实世界数据证实了这些结果,表明延长治疗间隔可改善解剖学结果,尽管最佳矫正视力(BCVA)的改善情况仍各不相同。高剂量阿柏西普在PHOTON和PULSAR等标志性临床试验中同样显示出不劣性,且给药间隔延长。然而,高剂量阿柏西普的全面真实世界数据仍然有限,需要进一步研究。

总结

法西单抗和高剂量阿柏西普在通过延长给药间隔减轻湿性年龄相关性黄斑变性和糖尿病性黄斑水肿的治疗负担方面都显示出前景,同时与标准抗VEGF治疗相比,能维持或改善临床结果。法西单抗在临床试验和真实世界研究中均已证明了这一点,而高剂量阿柏西普在试验中显示出类似的耐用性,但需要更多真实世界证据。

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