Perfluorohexyloctane Ophthalmic Solution: A Review in Dry Eye Disease

Area of Science:

• Ophthalmology
• Dry Eye Disease Research
• Ocular Surface Disease

Background:

• Dry eye disease (DED) is frequently associated with meibomian gland dysfunction (MGD), leading to excessive tear evaporation.
• The lipid layer of the tear film plays a crucial role in preventing evaporation.

Purpose of the Study:

• To evaluate the efficacy and tolerability of perfluorohexyloctane ophthalmic solution for DED associated with MGD.
• To assess the long-term effects of perfluorohexyloctane ophthalmic solution in DED patients.

Main Methods:

• Phase III clinical trials (GOBI and MOJAVE) involving adults with DED and MGD.
• Administration of one drop of perfluorohexyloctane ophthalmic solution four times daily per eye for 8 weeks, compared to hypotonic saline.
• An extension study (KALAHARI) assessed long-term outcomes up to 52 weeks.

Main Results:

• Perfluorohexyloctane ophthalmic solution demonstrated statistically significant and clinically meaningful improvements in DED signs and symptoms compared to placebo.
• The treatment was generally well-tolerated, with most adverse events being mild to moderate.
• Efficacy and tolerability were sustained up to 52 weeks in the extension study.

Conclusions:

• Perfluorohexyloctane ophthalmic solution is a first-in-class, preservative-free treatment for DED associated with MGD.
• It addresses excessive tear evaporation by stabilizing the tear film's lipid layer.
• It represents a valuable new therapeutic option for managing DED in the USA.