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全氟己基辛烷滴眼液治疗干眼的研究进展。

Perfluorohexyloctane Ophthalmic Solution: A Review in Dry Eye Disease.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2024 Apr;84(4):441-448. doi: 10.1007/s40265-024-02016-5. Epub 2024 Mar 30.

Abstract

Perfluorohexyloctane ophthalmic solution (Miebo) is a single-entity, water-, steroid- and preservative-free, first-in-class semifluorinated alkane that is approved in the USA for the treatment of the signs and symptoms of dry eye disease (DED). DED is often linked with meibomian gland dysfunction (MGD), which causes an excessive evaporation of tears. Perfluorohexyloctane ophthalmic solution stabilizes the lipid layer of the tear film and inhibits tear evaporation by forming a monolayer at the air-liquid interface. In the phase III GOBI and MOJAVE trials in adults with DED associated with MGD, one drop of perfluorohexyloctane ophthalmic solution instilled in each eye four times daily over 8 weeks resulted in statistically significant and clinically meaningful improvements in the signs and symptoms of DED compared with hypotonic saline (0.6%). The agent was generally well tolerated, with most ocular adverse events being mild or moderate in severity. The efficacy and tolerability of perfluorohexyloctane ophthalmic solution was sustained for up to 52 weeks in an extension study (KALAHARI). As the first and currently the only prescription treatment approved in the USA directly addressing the pathophysiology of excessive tear evaporation, perfluorohexyloctane ophthalmic solution is a valuable emerging option for the management of DED.

摘要

全氟己基辛烷滴眼液(Miebo)是一种单一实体、水基、不含类固醇和防腐剂的首个半氟化烷烃类药物,已获美国批准用于治疗干眼症(DED)的体征和症状。DED 通常与睑板腺功能障碍(MGD)有关,后者会导致泪液过度蒸发。全氟己基辛烷滴眼液通过在气液界面形成单层来稳定泪膜的脂质层并抑制泪液蒸发。在 GOBI 和 MOJAVE 三期临床试验中,患有与 MGD 相关的 DED 的成年人,每日每眼滴入 4 次 1 滴全氟己基辛烷滴眼液,持续 8 周,与 0.6%低渗盐水相比,DED 的体征和症状有统计学意义和临床意义的改善。该药物总体耐受性良好,大多数眼部不良反应的严重程度为轻度或中度。在一项扩展研究(KALAHARI)中,全氟己基辛烷滴眼液的疗效和耐受性可持续长达 52 周。作为美国首个也是目前唯一一个直接针对过度泪液蒸发病理生理学的处方治疗药物,全氟己基辛烷滴眼液是治疗 DED 的一种有价值的新兴选择。

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