ImportanceMonitoring for and reporting potential cases of intraocular inflammation (IOI) in clinical practice despite limited occurrences in clinical trials, including experiences with relatively new intravitreal agents, such as brolucizumab, pegcetacoplan, or faricimab, helps balance potential benefits and risks of these agents.ObjectiveTo provide descriptions of 3 initially culture-negative cases of acute, severe, posterior-segment IOI events occurring within the same month following intravitreal faricimab injections at a single institution.Design, Setting, and ParticipantsIn this case series, 3 patients manifesting acute, severe IOI following intravitreal injection of faricimab were identified between September 20, 2023, and October 20, 2023.ExposureFaricimab, 6 mg (0.05 mL of 120 mg/mL solution), for neovascular age-related macular degeneration among patients previously treated with aflibercept; 1 patient also had prior exposure to bevacizumab.Main Outcomes and MeasuresVisual acuity, vitreous taps for bacterial or fungal cultures, and retinal imaging.ResultsAll 3 patients received intravitreal faricimab injections between September 20 and October 20, 2023, from 2 different lot numbers (expiration dates, July 2025) at 3 locations of 1 institution among 3 of 19 retina physicians. Visual acuities with correction were 20/63 OS for patient 1, 20/40 OD for patient 2, and 20/20 OS for patient 3 prior to injection. All 3 patients developed acute, severe inflammation involving the anterior and posterior segment within 3 to 4 days after injection, with visual acuities of hand motion OS, counting fingers OD, and hand motion OS, respectively. Two patients were continuing faricimab treatment while 1 patient was initiating faricimab treatment. All received intravitreal ceftazidime, 2.2 mg/0.1 mL, and vancomycin, 1 mg/0.1 mL, immediately following vitreous taps. All vitreous tap culture results were negative. One patient underwent vitrectomy 1 day following presentation. Intraoperative vitreous culture grew 1 colony of Staphylococcus epidermidis, judged a likely contaminant by infectious disease specialists. All symptoms resolved within 1 month; visual acuities with correction were 20/100 OS for patient 1, 20/50 OD for patient 2, and 20/30 OS for patient 3.Conclusions and RelevanceIn this case series, 3 patients with acute, severe IOI within 1 month at 3 different locations among 3 ophthalmologists of 1 institution following intravitreal faricimab could represent some unknown storage or handling problem. However, this cluster suggests such inflammatory events may be more common than anticipated from faricimab trial reports, emphasizing the continued need for vigilance to detect and report such cases following regulatory approval.

中文翻译：

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玻璃体内注射 Faricimab 后出现严重眼内炎症

尽管临床试验中发生的情况有限，但在临床实践中监测和报告潜在的眼内炎症 (IOI) 病例，包括使用相对较新的玻璃体内药物（如 brolucizumab、pegcetacoplan 或 faricimab）的经验，有助于平衡这些药物的潜在益处和风险。提供了在同一机构玻璃体内注射法里昔单抗后同一个月内发生的 3 例最初培养阴性病例的急性、严重、后段 IOI 事件的描述。设计、设置和参与者在该病例系列中，3 名患者表现出急性、严重 IOI 2023年9月20日至2023年10月20日期间，玻璃体内注射faricimab后发现了这种情况。暴露Faricimab，6 mg（0.05 mL 120 mg/mL溶液），用于治疗既往接受阿柏西普治疗的患者中的新生血管性年龄相关性黄斑变性；1 名患者之前也曾接触过贝伐珠单抗。主要结果和测量视力、细菌或真菌培养的玻璃体穿刺以及视网膜成像。结果所有 3 名患者在 2023 年 9 月 20 日至 10 月 20 日期间接受了玻璃体内注射法瑞昔单抗，注射剂量为 2 个不同批号（过期时间）日期，2025 年 7 月），在 19 名视网膜医生中的 3 名中的 1 个机构的 3 个地点进行。注射前，患者 1 的矫正视力为 20/63 OS，患者 2 为 20/40 OD，患者 3 为 20/20 OS。所有3例患者均在注射后3至4天内出现累及眼前段和后段的急性、严重炎症，分别具有手部运动OS、数手指OD和手部运动OS的视力。两名患者正在继续 Faricimab 治疗，而 1 名患者正在开始 Faricimab 治疗。所有患者在玻璃体穿刺后立即接受玻璃体内注射头孢他啶 2.2 mg/0.1 mL 和万古霉素 1 mg/0.1 mL。所有玻璃体抽检培养结果均为阴性。一名患者在就诊后 1 天接受了玻璃体切除术。术中玻璃体培养长出1个菌落表皮葡萄球菌，被传染病专家判断为可能的污染物。所有症状在1个月内消失；患者 1 的矫正视力为 20/100 OS，患者 2 为 20/50 OD，患者 3 为 20/30 OS。结论和相关性在该病例系列中，3 名患者在 1 个月内在 3 个不同的地方出现急性、严重 IOI。 1 个机构的 3 名眼科医生在玻璃体内注射法里昔单抗后的位置可能代表一些未知的储存或处理问题。然而，这一集群表明此类炎症事件可能比 Faricimab 试验报告中预期的更为常见，强调在监管部门批准后仍需保持警惕，以发现和报告此类病例。