NOV03 for Dry Eye Disease Associated with Meibomian Gland Dysfunction

Ophthalmology Volume 130, Number 5, May 2023

中文摘要

本研究旨在評估NOV03（perfluorohexyloctane,全氟己氧基辛烷）眼用滴劑在患者中的療效和安全性。NOV03是一種新型的、不含防腐劑、由全氟己氧基辛烷（一種無水的半氟烷）組成的眼用滴劑，目前正在美國食品藥品監督管理局進行審查，作為治療與Dry eye disease associated with meibomian gland dysfunction的局部藥物。本研究為一個階段3、多中心、隨機、雙盲、0.6% hypotonic saline對照試驗，共納入359名符合條件的患者，經過8週治療後，在total corneal fluoreicin staining (tCFS)和VAS dryness評分（0-100視覺類比標度）方面，NOV03組的改善優於鹽水對照組，且在安全性方面未發現明顯差異。NOV03可能通過形成長效抗蒸發屏障來預防水分蒸發，從而改善DED相關症狀。

English Abstract

The article discusses the efficacy and safety of a novel treatment for dry eye disease associated with meibomian gland dysfunction. The treatment, called NOV03, is a nonaqueous, preservative-free, ophthalmic drop consisting of perfluorohexyloctane. The study found that NOV03 significantly improved both signs and symptoms of dry eye disease compared to a hypotonic saline control group. The results suggest that NOV03 may be a highly effective treatment for dry eye disease associated with meibomian gland dysfunction. The article also provides information on the causes of dry eye disease and the traditional therapies used to treat it.