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眼后段曲安奈德注射悬浮液治疗非感染性葡萄膜炎相关黄斑水肿:疗效和安全性的深入观察。

Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety.

机构信息

Truhlsen Eye Institute, 3902 Leavenworth Street. Omaha, NE 68105.

出版信息

Am J Manag Care. 2023 Feb;29(2 Suppl):S19-S28. doi: 10.37765/ajmc.2023.89324.

Abstract

Patients with macular edema (ME) associated with uveitis (UME) are at risk for vision loss and decreased quality of life, and they often experience high health care costs and rates of workforce absenteeism. Systemically or locally delivered corticosteroids are the mainstay of treatment for UME. Although traditional corticosteroid treatments may demonstrate high levels of efficacy, systemic delivery carries the risk of potentially serious systemic adverse effects (AEs), and standard local modes of delivery may be associated with low bioavailability in posterior ocular tissues and steroid-associated AEs due to anterior ocular tissue exposure. Drug injection into the suprachoroidal space (SCS) allows for targeted delivery to chorioretinal tissues with high bioavailability in the posterior segment, as well as for inherent drug sequestration away from the anterior segment, which may lower the risk of AEs associated with anterior tissue exposure to steroids. A novel triamcinolone acetonide (TA) injectable suspension formulated for administration to the SCS, SCS-TA (Xipere®; Bausch + Lomb), received FDA approval in 2021 for the treatment of UME. It is administered via the SCS Microinjector® (Clearside Biomedical, Inc), a device specifically designed for SCS delivery of ocular therapeutics. This approval was based on results from the phase 3 PEACHTREE clinical trial (NCT02595398) that demonstrated the clinical efficacy-including significantly increased visual acuity and decreased central subfield thickness-and safety of SCS-TA in patients with UME. Results from this trial, as well as from its long-term observational extension (MAGNOLIA; NCT02952001) and an open-label safety study (AZALEA; NCT03097315), support the possibility that treatment with SCS-TA may address the burden of disease in patients with UME.

摘要

与葡萄膜炎(Uveitis,UME)相关的黄斑水肿(Macular Edema,ME)患者有视力丧失和生活质量下降的风险,并且经常面临高昂的医疗保健费用和劳动力缺勤率。全身性或局部给予皮质类固醇是 UME 的主要治疗方法。虽然传统皮质类固醇治疗可能显示出较高的疗效,但全身性给药存在潜在严重全身性不良反应(Adverse Events,AEs)的风险,而标准局部给药方式可能由于前部眼组织暴露而导致后部眼组织中的生物利用度较低和与类固醇相关的 AEs。将药物注射到脉络膜上腔(Suprachoroidal Space,SCS)允许将药物靶向递送到脉络膜视网膜组织,从而在后节中具有较高的生物利用度,并且由于药物被隔离在前段之外,从而降低了与前部组织暴露于类固醇相关的 AEs 的风险。一种新型曲安奈德(Triamcinolone Acetonide,TA)注射悬浮液被配制用于 SCS 给药,SCS-TA(Xipere®;Bausch + Lomb)于 2021 年获得 FDA 批准用于治疗 UME。它通过 SCS Microinjector®(Clearside Biomedical,Inc)给药,这是一种专门为 SCS 递药而设计的装置。该批准基于 3 期 PEACHTREE 临床试验(NCT02595398)的结果,该试验表明 SCS-TA 在 UME 患者中的临床疗效-包括显著提高视力和减少中心凹下厚度-以及安全性。该试验的结果,以及其长期观察性扩展(MAGNOLIA;NCT02952001)和开放标签安全性研究(AZALEA;NCT03097315),支持 SCS-TA 治疗可能减轻 UME 患者疾病负担的可能性。

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