Bausch + Lomb, a unit of Bausch Health (NYSE:BHC), and Novaliq said a second phase 3 trial of NOV03 met main goals of the study, which was evaluating the eye drop to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).

Novaliq CEO Christian Roesky said the companies intend to file for FDA approval of NOV03 during Q2 2022.

“The findings show that NOV03 met both efficacy endpoints, which reinforces the results from the first pivotal Phase 3 clinical trial and builds upon the growing body of evidence in support of NOV03 as a potential first-in-class treatment for dry eye disease associated with Meibomian gland dysfunction,” said Bausch Health Chairman and CEO Joseph Papa.

MGD occurs when there is an issue with certain glands in the eyelids that helps make oil layer of tears.

The phase 3 trial, dubbed MOJAVE, included 620 people aged 18 years and above who received either NOV03 (n=311 people) four times daily or hyptonic saline solution (n=309 people).

The company said that on day 57, change from baseline in total Corneal Fluorescein Staining (tCFS) was statistically significant for those on NOV03 compared to the control saline group.

The companies added that, on day 57, the VAS eye dryness score was statistically significantly improved in the NOV03 group compared to the control group; and tCFS and eye dryness VAS score was also statistically significant at day 15.

The companies noted that NOV03 was well tolerated with few people experiencing ocular adverse events (AE) in the study eye (9.6% NOV03 group, 9.7% control group).

Blepharitis (inflammation of the eyelids), which was mild, was the only AE that occurred in a >1% higher proportion of people treated with NOV03 (1.6%) versus control (0.3%), the companies said in a May 3 release.