GLP-1 receptor agonists and ocular safety- Pharmacokinetic insights into ischemic optic neuropathy and diabetic retinopathy risk: A review.

0 MEDICINE, RESEARCH & EXPERIMENTAL
Marwan Malluhi, Ahmad Al-Naemi, Saghir Akhtar
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Abstract

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have transformed the management of type 2 diabetes mellitus and obesity, but their expanding use has raised concerns about ocular safety. This narrative review aimed to evaluate associations between individual GLP-1 RAs and the risk of developing non-arteritic anterior ischemic optic neuropathy (NAION) or diabetic retinopathy (DR), with particular emphasis on whether pharmacokinetic exposure and formulation explain within-class heterogeneity. PubMed was searched through June 2026, without a lower date limit, for human clinical trials, observational studies, and meta-analyses reporting quantitative ocular outcomes; reference lists, regulatory prescribing information, and pharmacokinetic data were also reviewed. Reported hazard ratios ranged from 1.29 to 7.64 for NAION and from 0.42 to 1.76 for DR. The most consistent NAION signal involved high-exposure subcutaneous semaglutide, whereas findings for oral semaglutide, liraglutide, dulaglutide, exenatide, and tirzepatide were absent, inconsistent, or weaker. DR worsening was likewise most evident with high-bioavailability subcutaneous semaglutide, but appeared more closely related to rapid, large reductions in glycated hemoglobin (HbA1c), particularly reductions of at least 2%, than to a class-specific retinal effect. Observational exposure patterns supported a preliminary, hypothesis-generating NAION threshold at a steady-state concentration (Css) of approximately 30-55 nmol/L. Semaglutide 7.2 mg, with an estimated Css of approximately 230 nmol/L, and highly bioavailable oral orforglipron warrant formulation-specific postmarketing ocular surveillance, although direct evidence of NAION risk remains unavailable. Current evidence does not support class-wide prescribing restrictions. An individualized approach considering patient-specific ocular risk, agent, formulation, and dose is more appropriate, while prospective studies with standardized ophthalmic endpoints are needed to establish causality and validate pharmacokinetic and pharmacogenomic risk parameters.

GLP-1受体激动剂和眼部安全-缺血性视神经病变和糖尿病视网膜病变风险的药代动力学见解:综述。
胰高血糖素样肽-1受体激动剂(GLP-1 RAs)已经改变了2型糖尿病和肥胖症的治疗,但它们的广泛使用引起了人们对眼部安全的担忧。本综述旨在评估个体GLP-1 RAs与发生非动脉性前缺血性视神经病变(NAION)或糖尿病性视网膜病变(DR)风险之间的关系,特别强调药代动力学暴露和制剂是否解释了类内异质性。PubMed检索了截至2026年6月的人类临床试验、观察性研究和报告定量眼科结果的荟萃分析,没有较低的日期限制;参考文献清单,法规处方信息和药代动力学数据也进行了审查。报道的NAION的危险比为1.29 - 7.64,dr的危险比为0.42 - 1.76。最一致的NAION信号涉及高暴露的皮下semaglutide,而口服semaglutide、利拉鲁肽、dulaglutide、艾塞那肽和替西帕肽的发现则不存在、不一致或较弱。同样,高生物利用度皮下注射semaglutide时,DR恶化最为明显,但与糖化血红蛋白(HbA1c)的快速大幅降低(尤其是至少2%的降低)密切相关,而不是与类别特异性视网膜效应密切相关。观测暴露模式支持稳态浓度(Css)约为30-55 nmol/L的初步假设。Semaglutide 7.2 mg,估计Css约为230 nmol/L,以及高度生物利用的口服orforglipron,尽管仍没有关于NAION风险的直接证据,但仍需要进行处方特异性的上市后眼科监测。目前的证据不支持班级范围的处方限制。考虑患者特异性眼部风险、药物、配方和剂量的个体化方法更为合适,而标准化眼科终点的前瞻性研究需要建立因果关系并验证药代动力学和药物基因组学风险参数。
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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CiteScore
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