Clinical Trials Show Positive Results for Novel Therapy for Dry Eye Disease

NOV03 (perfluorohexyloctane), a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease related to Meibomian gland dysfunction (MGD), has met both primary endpoints in two pivotal phase 3 trials.

NOV03 was developed by Novaliq and Bausch + Lomb. (Editor’s note: Bausch + Lomb in May 2022 finalized its separation from Bausch Health Companies and began trading as a separate company.) It prevents excessive tear evaporation and has the ability to restores tear film balance. It stabilizes the lipid layer for hours to protect the tear film and has the ability to penetrate the Meibomian glands.

In both trials, 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. Results for the GOBI trial were presented at the annual meeting of the 2022 American Society for Cataract and Refractive Surgery (ASCRS) held in Washington, D.C., in April 2022.

Results from the MOJAVE trial were presented virtually at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in May 2022.

The GOBI study was based on results from 597 participants ages 18 years and older who were randomized to either receive treatment with NOV03 four times daily or saline solution four times daily.

On day 57, change from baseline in total corneal fluorescein staining (tCFS) was statistically significant in the NOV03 arm compared with the control saline group. Fluorescein staining is a test that uses orange dye and blue light to detect anything foreign in the eye, as well as damage to the cornea.

Additionally on day 57, eye dryness visual analog scale (VAS) score—which tests pain—was statistically significantly improved in the NOV03 arm compared with the control group. tCFS and eye dryness VAS score was also statistically significant at day 15 (secondary endpoint).

In the study, NOV03 was well tolerated with few patients experiencing ocular side effects. Blurred vision, mostly mild and transient, was the only side effect that occurred in a higher proportion of subjects treated with NOV03.

Joseph Tauber, M.D.

“The fact that NOV03 met both primary endpoints in a single study, which is a rare event in clinical trials in dry eye disease, reinforces its potential as a treatment for addressing both the signs and symptoms of the disease. The unique mechanism of action makes NOV03 an exciting investigational treatment for the signs and symptoms of dry eye,” Joseph Tauber, M.D., founder of Tauber Eye Center in Kansas City, Mo., and leading NOV03 trial investigator, said in a press release.

In the MOJAVE trial, the data were based on results from 620 patients 18 years and older who were randomized to either receive treatment with NOV03 four times daily or hypotonic saline solution four times daily. At day 57, change from baseline in tCFS was statistically significant. Additionally on day 57, VAS eye dryness score was statistically significantly improved in the NOV03 arm compared to control group.

In MOJAVE, 9.6% of patients in the NOV03 group experienced ocular side effects.

John Sheppard, M.D.

“Treatment options for dry eye disease associated with Meibomian gland dysfunction in the United States are currently limited to mechanical methods, such as medical devices, warm compresses, lid scrubs and massage. If approved, NOV03 would offer eye care professionals a promising new therapeutic pharmaceutical approach for these patients,” John Sheppard, M.D., NOV03 trial investigator, said in a press release. He is also professor of Ophthalmology, Eastern Virginia Medical School, Norfolk, Va., EyeCare Partners Mid-Atlantic medical director.

The results of a second phase 3 study, MOJAVE, found that NOV03 met all of it primary endpoints, which also were change from baseline in total corneal fluorescein staining and on eye dryness on the visual analog scale at day 57.

“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,” Joseph C. Papa, chairman and CEO, Bausch Health said in a press release. "We intend to submit for approval during the second quarter of 2022.

Dry eye disease is one of the most common ocular surface disorders, causing discomfort for about 18 million Americans. Meibomian gland dysfunction is a major cause of the development and progression of evaporative dry eye disease, which is caused by a deficient tear film lipid layer that leads to increased tear evaporation.