Efficacy of NOV03 (Perfluorohexyloctane) on Signs and Symptoms of Dry Eye Disease associated with Meibomian Gland Dysfunction: The Mojave study

Abstract

Purpose : To assess the efficacy and safety of NOV03 (100% perfluorohexyloctane; F6H8) an investigational, novel, water-free, preservative-free sterile eye drop dosed four times a day (QID) compared to hypotonic saline eye drops for the treatment of the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).

Methods : Mojave was a Phase 3, multicenter, randomized, comparator-controlled, double-masked study conducted in subjects ≥18 years with DED associated with MGD. Eligible subjects were randomized 1:1 to NOV03 or hypotonic saline and instilled 1 drop QID into both eyes for approximately 57 days. Efficacy was assessed at Day 15, Day 29, and Day 57. Primary efficacy endpoints were the change from baseline (CFB) in total corneal fluorescein staining (tCFS; primary sign) and in VAS dryness score (primary symptom) at Day 57. The study eye was the eye with the worse tCFS score at baseline. Safety endpoints included adverse events (AEs), visual acuity, biomicroscopy, fundoscopy and intraocular pressure.

Results : A total of 620 subjects were randomized and treated (n=311 NOV03; n=309 saline). Mean age was 53.6 years, and the majority of subjects were female (78.7%). On Day 57, mean (SD) CFB in tCFS (–2.3 [2.8] NOV03 group vs –1.1 [2.9] saline group) and eye dryness VAS score (–29.5 [28.6] NOV03 group vs –19.0 [27.2] saline group) were statistically significantly different in favor of NOV03 (P<0.001 for both). Few subjects experienced ocular AEs in the study eye (9.6% NOV03 group, 9.7% saline group). Blepharitis, mostly mild, was the only AE that occurred in a >1% higher proportion of subjects treated with NOV03 vs saline (1.6% vs 0.3%). Other safety assessments were unremarkable.

Conclusions : In this Phase 3 study of subjects with DED associated with MGD, NOV03 eye drops demonstrated statistically significant improvements over hypotonic saline eye drops in both the primary sign (tCFS) and the primary symptom (VAS dryness) endpoints. NOV03 appeared well tolerated in this population. Efficacy and safety findings were consistent with those reported in a previous Phase 3 study (Gobi).

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.