Ophthalmic Drop Improves Signs, Symptoms of Dry Eye Disease in Phase 3 Trial

A perfluorohexyloctane ophthalmic drop demonstrated clinically meaningful improvement in signs and symptoms of dry eye disease associated with meibomian gland dysfunction compared with hypotonic saline, according to results from a phase 3 trial published in Ophthalmology.

“NOV03, a novel, nonaqueous, single-entity, preservative-free, ophthalmic drop consisting of perfluorohexyloctane (an anhydrous, semifluorinated alkane), currently is under review at the US Food and Drug Administration (FDA) in the United States as a topical therapy for dry eye disease associated with meibomian gland dysfunction,” wrote corresponding author Jason L. Vittitow, PhD, of Bausch + Lomb of Bridgewater, New Jersey, and coauthors.

The study included 597 adult patients with a history of dry eye disease in both eyes, a tear film break-up time of 5 or fewer seconds, unanesthetized Schirmer I test score of at least 5 mm, total meibomian gland dysfunction score of 3 or higher, and total corneal fluorescein staining score between 4 and 11 per the National Eye Institute scale. The double-masked, multicenter trial randomized 303 patients to NOV03 and 294 patients to saline over 8 weeks. Patients administered their assigned drop into each eye 4 times daily.

According to results from the study, change from baseline at week 8 was significantly greater with NOV03 compared with hypotonic saline for both primary end points: total corneal fluorescein staining and patient-reported eye dryness. Improvement also significantly favored NOV03 for all key secondary end points, including rapid effect that reduced total corneal fluorescein staining and eye dryness by week 2, improvement in central corneal fluorescein staining at week 8, and improvement in eye burning or stinging at week 8.

Ocular adverse events were of mild severity for the most part, and no serious ocular adverse events occurred, the study showed. Due to eye irritation considered severe in intensity, one patient discontinued NOV03.

“There are currently no FDA-approved, prescription pharmacologic treatments for dry eye disease associated with meibomian gland dysfunction,” researchers wrote, “and the results of this study suggest that NOV03 may potentially fulfill this unmet need.”

Reference: 
Tauber J, Berdy GJ, Wirta DL, Krösser S, Vittitow JL; GOBI Study Group. NOV03 for dry eye disease associated with meibomian gland dysfunction: results of the randomized phase 3 GOBI study. Ophthalmology. 2023;130(5):516-524. doi:10.1016/j.ophtha.2022.12.021