Bausch + Lomb Presents Data from Second Pivotal Phase 3 Trial of Investigational Treatment NOV03

Bausch + Lomb and Novaliq announced that data from the second pivotal phase 3 trial (MOJAVE) of investigational treatment NOV03 (perfluorohexyloctane) were presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting. NOV03 is being investigated as a first-in-class treatment with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).

“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,” Joseph C. Papa, chairman and CEO, Bausch Health, said in a company news release. “If approved, NOV03 would be the first pharmaceutical therapy available in the United States with a novel mechanism of action designed to alleviate both signs and symptoms for those suffering with dry eye disease associated with Meibomian gland dysfunction.”

The data presented from the second phase 3, multicenter, randomized, hypotonic saline-controlled, double masked trial show NOV03 met both primary efficacy endpoints: total Corneal Fluorescein Staining (tCFS), a measure of assessing damage to the eye, and VAS eye dryness endpoints at day 57.

“We are excited to see consistent data on multiple fronts across both phase 3 studies of NOV03. In addition to meeting each of the primary sign and symptom efficacy endpoints, NOV03 continues to appear to be well tolerated in this population,” John Sheppard, MD, professor of Ophthalmology, Eastern Virginia Medical School, Norfolk, Va., EyeCare Partners Mid-Atlantic Medical Director and NOV03 trial investigator, said in a company news release. “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.”⁵

The data was based on results from 620 participants ages 18 years and older who were randomized to either receive treatment with NOV03 four times daily or hypotonic saline solution four times daily (n=311 NOV03; n=309 saline). Key points from the trial 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 (-2.3 [2.8] vs. -1.1 [2.9]) (P<0.001) (primary endpoint).
• Additionally on day 57, VAS eye dryness score was statistically significantly improved in the NOV03 arm compared to control group (-29.5 [28.6] vs. -19.0 [27.2]) (P<0.001) (primary endpoint).
• tCFS and VAS eye dryness score were also statistically significant at day 15 (secondary endpoints).

In the trial, NOV03 was well tolerated with few subjects experiencing ocular adverse events (AE) in the study eye (9.6% NOV03 group, 9.7% control group). Blepharitis, mostly mild, was the only AE that occurred in a >1% higher proportion of subjects treated with NOV03 versus control (1.6% vs 0.3%).

“These results reaffirm the safety and efficacy data of NOV03 as a potential treatment option for patients with dry eye disease associated with Meibomian gland dysfunction,” said Christian Roesky, PhD, CEO, Novaliq. “In collaboration with Bausch Health and Bausch + Lomb, we look forward to submitting NOV03 for FDA approval during the second quarter of 2022 with the potential to bring a novel drug option for this condition to the United States.”

References

1. Leonardi, A., Modugno, R. L., & Salami, E. (2021). Allergy and Dry Eye Disease. Ocular immunology and inflammation, 29(6), 1168–1176. https://doi.org/10.1080/09273948.2020.1841804.
2. 2020 Dry Eye Products Market Report: A global Analysis for 2019 to 2025. Market Scope. Retrieved from https://www.market-scope.com/pages/reports/250/2020-ophthalmic-landscape-report-global-analysis-for-2019-to-2025-april-2021#reports.
3. Findlay, Q., & Reid, K. (2018). Dry eye disease: when to treat and when to refer. Australian prescriber, 41(5), 160–163. https://doi.org/10.18773/austprescr.2018.048.
4. Lemp, M. A., Crews, L. A., Bron, A. J., Foulks, G. N., & Sullivan, B. D. (2012). Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea, 31(5), 472–478. doi: 10.1097/ICO.0b013e318225415a.
5. Meibomian Gland Dysfunction and Treatment. American Association for Pediatric Opthalmology and Strabismus. Retrieved from https://aapos.org/glossary/meibomian-gland-dysfunction-and-treatment. Accessed 4/21/22.
6. In December 2019, Bausch Health acquired the rights from Novaliq GmbH to pursue development and commercialization of NOV03 for DED and combination products based on NOV03 in additional ophthalmic indications in the United States and Canada.
7. Tauber J, Wirta DL, Sall K, Majmudar PA, Willen D, Krösser S; SEECASE study group. A Randomized Clinical Study (SEECASE) to Assess Efficacy, Safety, and Tolerability of NOV03 for Treatment of Dry Eye Disease. Cornea. 2021; 40(9):1132-1140.