Faricimab Outcomes in Chorioretinal Disorders: Indian Real-World Analysis (FOCUS Study).

Clinical ophthalmology (Auckland, N.Z.) Pub Date : 2025-06-12 eCollection Date: 2025-01-01 DOI:10.2147/OPTH.S521384

Vishal Agrawal, Ayushi Gupta, Virendra Agrawal, Jay Umed Sheth

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引用次数: 0

Abstract

Purpose: To assess the real-world efficacy and safety of intravitreal faricimab in treating Diabetic Macular Edema (DME), neovascular Age-related Macular Degeneration (nAMD), and Central Macular Edema (CME) secondary to retinal vein occlusion (RVO) in an Indian population.

Patients and methods: This single‑center, retrospective observational study reviewed the records of 49 patients (49 eyes) diagnosed with DME, nAMD, or cystoid macular edema secondary to RVO, who received a total of 150 intravitreal faricimab injections and were followed for at least 24 weeks. Patients received intravitreal faricimab injections, with follow-up at four-week intervals. Outcome measures included changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT), along with resolution of intraretinal (IRF) and subretinal fluid (SRF) in nAMD patients.

Results: Faricimab significantly improved BCVA and reduced CMT across all groups after a mean follow-up period of 33.31 (± 7.41) weeks. DME patients' BCVA improved from 0.71 (± 0.36) LogMAR to 0.46 (± 0.35) LogMAR (P<0.0001), nAMD from 1.24 (± 0.73) to 0.43 (± 0.43) LogMAR (P=0.00003), and RVO from 0.78 (± 0.32) to 0.38 (± 24) LogMAR (P=0.02). CMT decreased from 454.43 (± 164.76) µm to 255.3 (± 81.17) µm (P<0.00001) overall. Significant reductions were also observed in IRF and SRF in nAMD patients, with IRF decreasing from 48% to 16% (P=0.008) and SRF from 100% to 20% (P<0.00001). No significant adverse events, including intraocular inflammation (IOI), were reported.

Conclusion: Faricimab demonstrated significant visual and anatomical improvements across all diagnostic groups, including off‑label use in RVO‑associated CME during the study period, showing promise as an effective treatment for DME, nAMD, and RVO. These real-world outcomes align with clinical trial data (TENAYA, LUCERNE, YOSEMITE, RHINE), underscoring faricimab's potential as an effective, dual-action therapy for chorioretinal disorders.

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法利昔单抗治疗视网膜疾病的疗效：印度真实世界分析（FOCUS研究）。

目的：评估玻璃体内法利西单抗治疗印度人群继发于视网膜静脉阻塞（RVO）的糖尿病性黄斑水肿（DME）、新生血管性年龄相关性黄斑变性（nAMD）和中枢性黄斑水肿（CME）的实际疗效和安全性。患者和方法：这项单中心、回顾性观察性研究回顾了49例（49只眼睛）诊断为DME、nAMD或继发于RVO的囊样黄斑水肿的患者的记录，这些患者总共接受了150次玻璃体内法利西单抗注射，并随访了至少24 周。患者接受玻璃体内法利西单抗注射，每隔四周随访一次。结果测量包括nAMD患者最佳矫正视力（BCVA）和中央黄斑厚度（CMT）的变化，以及视网膜内（IRF）和视网膜下液（SRF）的分辨率。结果：在平均随访33.31（±7.41）周后，Faricimab显著改善了所有组的BCVA并降低了CMT。DME患者BCVA从0.71（±0.36）LogMAR改善至0.46（±0.35）LogMAR (PP=0.00003)， RVO从0.78（±0.32）LogMAR改善至0.38（±24）LogMAR （P=0.02）。CMT从454.43（±164.76）µm降至255.3（±81.17）µm (PP=0.008)， SRF从100%降至20% (p结论：Faricimab在所有诊断组中表现出显著的视觉和解剖改善，包括在研究期间在RVO相关CME中的非标签使用，显示出作为DME， nAMD和RVO的有效治疗的希望。这些实际结果与临床试验数据（TENAYA， LUCERNE， YOSEMITE， RHINE）一致，强调了faricimab作为一种有效的双作用治疗脉络膜视网膜疾病的潜力。

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

Clinical ophthalmology (Auckland, N.Z.)

CiteScore

4.10

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0.00%

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