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目前已获批及即将上市的干眼症治疗方法的精髓。

Quintessence of currently approved and upcoming treatments for dry eye disease.

作者信息

Patil Sunanda, Sawale Gayatri, Ghuge Santosh, Sathaye Sadhana

机构信息

Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Nathalal Parekh Marg, near Khalsa College, Matunga East, Mumbai, 400019, India.

Department of Pharmacology, MET Institute of Pharmacy, Mumbai, India.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2025 Feb;263(2):269-278. doi: 10.1007/s00417-024-06587-7. Epub 2024 Aug 31.

Abstract

Dry eye disease (DED), also known as dry eye syndrome, is a multifactorial ocular surface disease. The aim of this review is to present the details of currently approved and upcoming treatment options for DED in a nutshell. We conducted a thorough literature search using PubMed and searched US FDA website, clinicaltrials.gov, and data available in public domain for currently approved and upcoming treatment options for DED. Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS [cyclosporine 0.05% ophthalmic emulsion], VEVYE [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED. The medical devices approved for treating DED due to meibomian glands dysfunction (MGD) include Lumenis OptiLight™ (intense pulsed light [IPL] device), TearCare system, and TearScience™ LipiFlow™ thermal pulsation system. Punctal plugs are another treatment option approved for management of DED. There are hundreds of clinical studies evaluating newer treatments for managing the signs and symptoms. Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS and other approved treatments. The potential treatments being assessed include IC 265, OK-101, PL9643, SYL1001 (tivanisiran), SHJ002, OXERVATE (cenegermin-bkbj ophthalmic solution 0.002%), HBM9036 (tanfanercept ophthalmic solution), OCS-02 (licaminlimab), MIM-D3 (tavilermide ophthalmic solution 5%), AR-15,512, BRM421, reproxalap, and AZR-MD-001 (selenium sulphide ointment 0.5%). The pathophysiology of DED is complex and multifactorial; there is a need to understand it even deeper. The new treatments and different delivery systems seem promising and provide a hope of effective treatment for DED.

摘要

干眼疾病(DED),也称为干眼综合征,是一种多因素的眼表疾病。本综述的目的是简要介绍目前已获批和即将出现的DED治疗方案的详细情况。我们使用PubMed进行了全面的文献检索,并搜索了美国食品药品监督管理局(FDA)网站、ClinicalTrials.gov以及公共领域的可用数据,以获取目前已获批和即将出现的DED治疗方案。目前,美国食品药品监督管理局(FDA)批准用于治疗DED的药物包括环孢素制剂(瑞珠滴眼液[0.05%环孢素眼用乳剂]、维眸[0.1%环孢素眼用溶液]和适利加™[0.09%环孢素眼用溶液])、Xiidra(lifitegrast),一种白细胞功能相关抗原-1(LFA-1)/细胞间黏附分子-1(ICAM-1)抑制剂、EYSUVIS™(0.25%洛替泼诺眼用混悬液),一种皮质类固醇,以及迈博瑞™(全氟己基辛烷眼用溶液),一种半氟化烷烃。思然™(酒石酸伐尼克兰溶液鼻喷雾剂),一种胆碱能激动剂,是另一种获批用于治疗DED体征和症状的制剂。因睑板腺功能障碍(MGD)而获批用于治疗DED的医疗器械包括科医人OptiLight™(强脉冲光[IPL]设备)、泪液护理系统和泪然科学™ LipiFlow™热脉动系统。泪小点栓子是另一种获批用于管理DED的治疗选择。有数百项临床研究在评估用于管理体征和症状的新治疗方法。正在将环孢素制剂TJO-087(0.08%环孢素A纳米乳剂)、SCAI-001滴眼液(0.01%、0.02%环孢素)与瑞珠滴眼液及其他获批治疗方法进行对比评估。正在评估的潜在治疗方法包括IC 265、OK-101、PL9643、SYL1001(替瓦尼西然)、SHJ002、欧思美(0.002%西奈吉明-bkbj眼用溶液)、HBM9036(坦法赛特眼用溶液)、OCS-02(利卡明利单抗)、MIM-D3(5%他维勒米德眼用溶液)、AR-15,512、BRM421、瑞普乐沙,以及AZR-MD-001(0.5%硫化硒软膏)。DED的病理生理学复杂且多因素;有必要更深入地了解它。新的治疗方法和不同的给药系统似乎很有前景,并为有效治疗DED带来了希望。

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