Early Anatomical and Functional Outcomes of Faricimab in Recalcitrant Neovascular Age-Related Macular Degeneration: A Retrospective Real-World Study in an East-Asian Population.

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2025-08-01 Epub Date: 2025-06-04 DOI:10.1007/s40123-025-01163-6

Yen-An Lai, Mei-Chi Tsui, Shuo-Fang Cheng, Yi-Ting Hsieh, Tso-Ting Lai, Yun Hsia, Shih-Wen Wang, I-Hsin Ma, Kuo-Chi Hung, Chang-Pin Lin, Chang-Hao Yang, Chung-May Yang, Tzyy-Chang Ho

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引用次数: 0

Abstract

Introduction: Neovascular age-related macular degeneration (nAMD) is a leading cause of vision loss, with some eyes showing recalcitrant disease despite standard anti-vascular endothelial growth factor (anti-VEGF) therapy. While clinical trials have demonstrated promising efficacy and safety of faricimab in treatment-naïve patients, only 9% of participants were Asian, and real-world data on its effectiveness in pretreated Asian populations remain limited. This study aims to evaluate the efficacy and longitudinal response of intravitreal faricimab in patients with recalcitrant nAMD in Taiwan by analyzing visual acuity, anatomical outcomes, and treatment interval extension over a 6-month period.

Methods: This was a retrospective observational study at National Taiwan University Hospital. Patients switched to intravitreal faricimab (6 mg/0.05 mL; Vabysmo™) from July 2023 to May 2024 with 6 months follow-up identified via electronic medical records. Injections were administered without a loading phase. Retreatment was guided by the presence of retinal fluid on optical coherence tomography (OCT), with or without visual decline.

Results: A total of 33 eyes from 28 patients were analyzed. Visual acuity remained stable over 6 months (p = 0.147). Central retinal thickness significantly improved from 267 to 235 μm at 3 months (p = 0.002) and remained stable at 6 months (p = 0.003). Subretinal fluid resolved in 36.4% of eyes at 3 months (p < 0.001) and 48.5% at 6 months (p = 0.002), while changes in intraretinal fluid (IRF) and pigment epithelial detachment (PED) height were not significant. Treatment intervals were extended in 52% of eyes, with 56% reaching ≥ 16 weeks (Q16W) intervals. No serious ocular or systemic adverse events were reported.

Conclusions: Intravitreal faricimab demonstrated improved anatomical outcomes with stable visual acuity and extended treatment intervals in patients with recalcitrant nAMD in Taiwan, addressing a key evidence gap. Future studies with longer follow-ups are needed to validate these findings.

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法利昔单抗治疗顽固性新生血管性年龄相关性黄斑变性的早期解剖和功能结果：东亚人群的回顾性真实世界研究。

简介：新生血管性年龄相关性黄斑变性（nAMD）是视力丧失的主要原因，尽管标准的抗血管内皮生长因子（anti-VEGF）治疗，一些眼睛仍表现出顽固性疾病。虽然临床试验已经证明faricimab在treatment-naïve患者中有希望的疗效和安全性，但只有9%的参与者是亚洲人，并且在治疗前的亚洲人群中其有效性的实际数据仍然有限。本研究旨在通过分析视力、解剖结果和治疗间隔延长6个月来评估法利西单抗在台湾顽固性nAMD患者中的疗效和纵向反应。方法：采用台湾大学附属医院的回顾性观察性研究。患者改用玻璃体内法昔单抗(6mg /0.05 mL；Vabysmo™)，从2023年7月至2024年5月，通过电子病历进行6个月的随访。注射时没有上样期。根据光学相干断层扫描（OCT）上视网膜液的存在指导重新治疗，有无视力下降。结果：对28例患者33只眼进行了分析。视力在6个月内保持稳定（p = 0.147）。视网膜中央厚度在3个月时从267 μm增加到235 μm (p = 0.002)， 6个月时保持稳定（p = 0.003）。结论：玻璃体内法利昔单抗改善了台湾顽固性nAMD患者的解剖结果，稳定了视力，延长了治疗间隔，解决了一个关键的证据空白。未来需要更长时间的随访研究来验证这些发现。

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of ophthalmic therapies. Open Access All articles published by Ophthalmology and Therapy are open access. 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