ImportanceRandomized clinical trials are conducted to establish both drug safety and efficacy. However, evidence of adverse events associated with these drugs in the clinical practice setting can be of value at generating hypotheses regarding less common safety issues, even if causality cannot be determined.ObjectiveTo present and analyze cases of intraocular inflammation associated with faricimab therapy in patients referred to a single European institution.Design, Setting, and ParticipantsThis was a review starting in April of 2024 of an observational case series. Patients were from a single academic-based tertiary referral center in Switzerland. Included in the analysis were patients referred for intraocular inflammation soon after receiving a faricimab intravitreal injection between June 1, 2022, and March 5, 2024.ExposureFaricimab, 6 mg (0.05 mL of a 120-mg/mL solution), administrated for neovascular age-related macular degeneration or diabetic macular edema.Main Outcomes and MeasuresThe systemic and ocular histories and imaging data available were reviewed. The following were evaluated: visual acuity measured with habitual correction using the Early Treatment of Diabetic Retinopathy Study charts before and after the event; intraocular pressure; patient symptoms; anterior, intermediate, or posterior location of the intraocular inflammation; and the presence of retinal vasculitis. Multimodal imaging including color fundus photographs, fluorescein angiograms, indocyanine green angiograms, and optical coherence tomography were reviewed.ResultsA total of 12 eyes from 7 patients (mean [SD] age, 73.3 [16.7] years; 4 female [57.1%]) over 22 months were identified as having noninfectious intraocular inflammation after intravitreal faricimab injections. Among these cases, in 2 eyes, retinal vasculitis was present together with anterior and posterior inflammation. One of the 2 eyes had an occlusive form of vasculitis of the arteries and veins, leading to subsequent macular capillary nonperfusion and clinically relevant irreversible vision deterioration from 20/80 to 20/2000. The remaining eyes were characterized by moderate anterior segment inflammation without substantial vision changes. The intraocular inflammation event occurred after a median (IQR) of 3.5 (2.0-4.3) faricimab injections. The median (IQR) interval between the last faricimab injection and the diagnosis of inflammation was 28 (24-38) days. Increased intraocular pressure of 30 mm Hg or higher was found in 3 eyes.Conclusions and RelevanceThis case series highlights the occurrence of rare, but potentially severe, intraocular inflammation associated with faricimab therapy. Although these findings do not prove causality and can only generate hypotheses for future investigations, these results suggest the importance of continuous surveillance and monitoring for patients undergoing faricimab therapy to promptly identify and manage potential adverse events.

中文翻译：

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与 Faricimab 相关的无菌性眼内炎症


重要性进行随机临床试验以确定药物安全性和有效性。然而，即使无法确定因果关系，在临床实践环境中与这些药物相关的不良事件的证据对于产生关于不太常见的安全问题的假设也很有价值。目的介绍和分析转诊至单一欧洲机构的患者与 faricimab 治疗相关的眼内炎症病例。设计、设置和参与者这是从 2024 年 4 月开始的观察性病例系列的综述。患者来自瑞士一家以学术为基础的三级转诊中心。分析包括在 2022 年 6 月 1 日至 2024 年 3 月 5 日期间接受 faricimab 玻璃体内注射后不久因眼内炎症转诊的患者。主要结局和测量回顾了全身和眼部病史以及可用的影像学数据。评估了以下内容： 在事件前后使用糖尿病视网膜病变早期治疗研究图表通过习惯性矫正测量的视力;眼压;患者症状;眼内炎症的前、中或后位置;以及存在视网膜血管炎。回顾了包括彩色眼底照片、荧光素血管造影、吲哚菁绿血管造影和光学相干断层扫描在内的多模式成像。结果在 22 个月内，来自 7 名患者 （平均 [SD] 年龄，73.3 [16.7] 岁;4 名女性 [57.1%]）的 12 只眼睛被确定为玻璃体内注射 faricimab 后患有非感染性眼内炎症。 在这些病例中，有 2 只眼睛出现视网膜血管炎以及前部和后部炎症。2 只眼睛中的一只患有动脉和静脉闭塞性血管炎，导致随后的黄斑毛细血管无灌注和临床相关的不可逆视力恶化，从 20/80 到 20/2000。其余眼睛的特征是中度眼前节炎症，没有明显的视力变化。眼内炎症事件发生在中位 （IQR） 为 3.5 （2.0-4.3） faricimab 注射后。最后一次 faricimab 注射与炎症诊断之间的中位 （IQR） 间隔为 28 （24-38） 天。发现 3 只眼睛的眼压升高 30 毫米汞柱或更高。结论和相关性本病例系列强调了与 faricimab 治疗相关的罕见但可能严重的眼内炎症的发生。尽管这些发现并不能证明因果关系，只能为未来的调查提供假设，但这些结果表明对接受 faricimab 治疗的患者进行持续监测和监测的重要性，以便及时识别和管理潜在的不良事件。