Bausch + Lomb Presents Data from First Pivotal Phase 3 Trial of Investigational NOV03 at ASCRS

Bausch + Lomb and Novaliq announced that data from the first pivotal phase 3 trial (GOBI) of NOV03 (perfluorohexyloctane), which is being investigated as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD), was presented as part of a podium presentation on April 24, 2022, at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in Washington, D.C.

“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,” Joseph Tauber, MD, founder of Tauber Eye Center in Kansas City, Mo., and leading NOV03 trial investigator, said in a company news release. “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.”

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

The data from the phase 3, multicenter, randomized, hypotonic saline-controlled, double masked 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 hyptonic saline solution four times daily (n=303 NOV03; n=294 saline). The key points of the study include:

• On day 57, change from baseline in total Corneal Fluorescein Staining (tCFS) was statistically significant in the NOV03 arm compared to the control saline group (-2.0 [2.6] vs. -1.0 [2.7]) (P<0.001) (primary endpoint).
• Additionally on day 57, eye dryness VAS score was statistically significantly improved in the NOV03 arm compared to control group (-27.4 [27.9] vs. -19.7 [26.6]) (P<0.001) (primary endpoint).
• tCFS and eye dryness VAS score was also statistically significant at day 15 (secondary endpoint).

In the study, NOV03 was well tolerated with few subjects experiencing ocular adverse events (AE) (8.3% NOV03 group, 5.1% control group). Blurred vision, mostly mild and transient, was the only AE that occurred in a higher proportion of subjects treated with NOV03 versus control (3.0% vs 0.3%).

“With its novel mode of action, NOV03 is specifically designed to alleviate the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction, and if approved, has the potential to address an unmet medical need,” said Christian Roesky, Ph.D., CEO, Novaliq. “We look forward to our continued collaboration with Bausch Health and Bausch + Lomb as we work together to potentially bring this novel treatment option to patients in the United States.”

About NOV03 (perfluorohexyloctane) Ophthalmic Solution

NOV03 is an investigational, proprietary, water-free, single-component preservative-free eye drop. In 2019, Bausch Health and Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 in the United States and Canada. In addition to the GOBI trial, positive topline data was announced from the second Phase 3 study (MOJAVE) in September 2021. Additional data from MOJAVE will be shared later this year during a future medical congress and scientific publication.