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解决过度蒸发问题:干眼疾病的未满足需求。

Addressing excessive evaporation: an unmet need in dry eye disease.

机构信息

Kentucky Eye Institute, 601 Perimeter Drive, Suite 100, Lexington, KY 40517. Email:

出版信息

Am J Manag Care. 2023 Oct;29(13 Suppl):S239-S247. doi: 10.37765/ajmc.2023.89448.

DOI:10.37765/ajmc.2023.89448
PMID:37844320
Abstract

Dry eye disease (DED) is a common condition in which tear film abnormalities result in a damaging cycle of tear hyperosmolarity, desiccating stress, inflammation, and ocular surface injury. In a healthy tear film, meibum produced by the meibomian glands forms a lipid layer that stabilizes the tear film and protects against aqueous tear evaporation. Excessive tear evaporation due to a deficient lipid layer is believed to be the most common cause of DED, and most evaporative DED is associated with meibomian gland dysfunction (MGD); this highlights the pathophysiologic importance of the dysfunctional tear lipid layer. Current treatments for DED may be used to supplement hyperosmolar aqueous tears, lubricate the ocular surface, increase meibum flow, decrease inflammation, promote tear production, or otherwise decrease clinical signs of ocular surface damage and/or improve symptoms. Until now, no prescription eye drop has directly addressed the excessive evaporation that occurs in most patients with DED. Perfluorohexyloctane (PFHO) ophthalmic solution (MIEBO™; Bausch + Lomb) is a preservative-free eye drop that has demonstrated the ability to form a long-lasting barrier that inhibits evaporation in preclinical studies. FDA approval of PFHO was based on results from 2 pivotal clinical trials (GOBI [NCT04139798] and MOJAVE [NCT04567329]) in patients with DED and clinical signs of MGD which demonstrated consistent improvements in both signs and symptoms of disease, with a safety profile similar to that of saline eye drops. PFHO is the first and only FDA-approved eye drop that directly targets tear evaporation in patients with DED, thereby promoting ocular surface healing and providing symptomatic relief.

摘要

干眼症(DED)是一种常见疾病,其特征为泪膜异常导致泪液高渗、干燥应激、炎症和眼表面损伤的破坏性循环。在健康的泪膜中,由睑板腺分泌的睑脂形成一层脂质层,稳定泪膜并防止水性泪液蒸发。由于脂质层不足导致的泪液过度蒸发被认为是 DED 的最常见原因,大多数蒸发性 DED 与睑板腺功能障碍(MGD)有关;这突出了功能失调的泪液脂质层在病理生理学上的重要性。目前针对 DED 的治疗方法可能用于补充高渗水性泪液、润滑眼表面、增加睑脂分泌、减少炎症、促进泪液产生或其他方式减少眼表面损伤的临床迹象和/或改善症状。到目前为止,还没有处方眼药水直接针对大多数 DED 患者发生的过度蒸发问题。全氟己基辛烷(PFHO)滴眼液(MIEBO™;Bausch + Lomb)是一种不含防腐剂的眼药水,已在临床前研究中证明具有形成长效屏障以抑制蒸发的能力。PFHO 的 FDA 批准基于两项关键性临床试验(GOBI [NCT04139798]和 MOJAVE [NCT04567329])的结果,这些试验入组了 DED 且有 MGD 临床体征的患者,结果一致显示疾病的体征和症状均得到改善,安全性与生理盐水眼药水相似。PFHO 是 FDA 批准的首款且唯一一款直接针对 DED 患者泪液蒸发的眼药水,可促进眼表面愈合并提供症状缓解。

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Curr Ther Res Clin Exp. 2025 Mar 20;102:100786. doi: 10.1016/j.curtheres.2025.100786. eCollection 2025.
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Efficacy and safety of a lipid-containing artificial tear compared with a non-lipid containing tear: a randomized clinical trial.含油人工泪液与不含油人工泪液的疗效和安全性比较:一项随机临床试验。
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