Faricimab for previously-treated eyes with neovascular age-related macular degeneration with inadequate response – 6-month interim analysis of the FURGGHORN study

IF 7 3区 医学 Q1 OPHTHALMOLOGY
Asia-Pacific Journal of Ophthalmology Pub Date : 2026-03-01 Epub Date: 2026-03-03 DOI:10.1016/j.apjo.2026.100299
Long T. Phan , Jennifer Chin , Geoffrey K. Broadhead , Thomas H. Hong , Hemal Mehta , John H. Chang , Samantha Fraser-Bell , Chui Ming Gemmy Cheung , Christopher Ziyu Sun , Alan P. Luckie , Sanjeewa S. Wickremasinghe , Gerald Liew , Jagjit S. Gilhotra , Matthew P. Simunovic , Nitin Verma , Andrew A. Chang
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引用次数: 0

Abstract

Purpose

To investigate the effect of switching to faricimab therapy patients with neovascular age-related macular degeneration currently treated with anti-VEGF therapy.

Design

Phase IV, prospective, single-arm, open-label, multi-center, investigator-initiated clinical trial.

Methods

Eligible eyes received four initial doses of faricimab 6 mg/0.05 mL every 4-weeks. From week 12, dosing intervals were increased to eight weeks and then modified according to a treat-and-extend based regimen. This interim analysis reports changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), retinal fluid proportions, and the incidence of adverse events from baseline through to week 24.

Results

One-hundred-and-two patients of mean age 76.0 years were recruited from 12 sites across Australia and Singapore. Baseline BCVA was 72 Early Treatment Diabetic Retinopathy Study letters and baseline CST was 384 µm. Seventy-two percent of eyes were being treated with aflibercept 2 mg and 28% with ranibizumab. After switching to faricimab, mean BCVA change was + 1.9 letters at week 12 (P < 0.001), and + 1.9 letters at week 24 (P < 0.001). Mean CST change was −83.9 µm at week 12 (P < 0.001), and −82.2 µm at week 24 (P < 0.001). The proportion of eyes with fluid resolution was 54% at week 12, and 59% at week 24. The proportion of eyes assigned to 4-weekly, 8-weekly, and 12-weekly treatment intervals were 16%, 35% and 49% respectively at week 24. Anterior chamber inflammation occurred in one eye with no cases of vasculitis or occlusive retinitis.

Conclusions

In this pre-specified interim analysis of a prospective study, patients switching to faricimab experienced improved anatomic outcomes and maintained visual function, with a large proportion assigned extended dosing intervals under a flexible treatment regimen.

Trial registration number

ACTRN12623000215628.
Faricimab治疗既往治疗的新生血管性年龄相关性黄斑变性反应不足的眼睛- FURGGHORN研究的6个月中期分析
目的:探讨目前接受抗vegf治疗的新生血管性年龄相关性黄斑变性患者改用法利西单抗治疗的效果。设计:IV期、前瞻性、单臂、开放标签、多中心、研究者发起的临床试验。方法:符合条件的眼睛每4周接受4次法利昔单抗初始剂量6mg/0.05mL。从第12周开始,给药间隔增加到8周,然后根据治疗和延长方案进行修改。该中期分析报告了从基线到第24周的最佳矫正视力(BCVA)、中心亚野厚度(CST)、视网膜液比例和不良事件发生率的变化。结果:从澳大利亚和新加坡的12个地点招募了122名平均年龄76.0岁的患者。基线BCVA为72早期治疗糖尿病视网膜病变研究字母,基线CST为384µm。72%的患者接受2mg阿非利赛普治疗,28%的患者接受雷尼单抗治疗。改用法昔单抗后,12周时平均BCVA变化为+1.9个字母(P < 0.001), 24周时为+1.9个字母(P < 0.001)。平均CST变化在第12周为-83.9µm (P < 0.001),在第24周为-82.2µm (P < 0.001)。在第12周和第24周,具有液体分辨力的眼睛比例分别为54%和59%。在第24周时,被分配到4周、8周和12周治疗间隔的眼睛比例分别为16%、35%和49%。前房炎症发生1眼,无血管炎或闭塞性视网膜炎病例。结论:在这项预先指定的前瞻性研究的中期分析中,改用faricimab的患者获得了改善的解剖结果并保持了视觉功能,并且很大一部分患者在灵活的治疗方案下延长了给药间隔。试验注册号:ACTRN12623000215628。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
8.10
自引率
18.20%
发文量
197
审稿时长
6 weeks
期刊介绍: The Asia-Pacific Journal of Ophthalmology, a bimonthly, peer-reviewed online scientific publication, is an official publication of the Asia-Pacific Academy of Ophthalmology (APAO), a supranational organization which is committed to research, training, learning, publication and knowledge and skill transfers in ophthalmology and visual sciences. The Asia-Pacific Journal of Ophthalmology welcomes review articles on currently hot topics, original, previously unpublished manuscripts describing clinical investigations, clinical observations and clinically relevant laboratory investigations, as well as .perspectives containing personal viewpoints on topics with broad interests. Editorials are published by invitation only. Case reports are generally not considered. The Asia-Pacific Journal of Ophthalmology covers 16 subspecialties and is freely circulated among individual members of the APAO’s member societies, which amounts to a potential readership of over 50,000.
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