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

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

“The data show that NOV03 met both primary endpoints of total Corneal Fluorescein Staining, a measure that assesses damage to the eye, and visual analogue scale dryness score at day 57,” said Joseph Tauber, founder of Tauber Eye Center in Kansas City, Missouri and leading NOV03 trial investigator.

The phase 3 trial, dubbed GOBI, included 597 people aged 18 years and above who either received NOV03 (n=303 people) four times daily or hyptonic saline solution (n=294 people).

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

On day 57, eye dryness VAS 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 company said in an April 25 press release.

The company said NOV03 was well tolerated with few subjects experiencing ocular adverse events (AE) (8.3% in NOV03 group and 5.1% in the control arm). Blurred vision, mostly mild and transient, was the only AE that occurred in a higher proportion of people treated with NOV03 (3.0%) compared to control (0.3%).

Bausch Health Chairman and CEO Joseph Papa said, “There is currently no pharmaceutical therapy in the United States approved for the treatment of dry eye disease associated with Meibomian gland dysfunction, and these data support NOV03 as a potential first-in-class option for the treatment of dry eye disease associated with Meibomian gland dysfunction.”

Papa added, “We intend to submit for approval during the second quarter of 2022.”