Bausch + Lomb Presents Data from Second Pivotal Phase 3 Trial of Investigational Treatment NOV03 (Perfluorohexyloctane) at the Association for Research in Vision and Ophthalmology Annual Meeting
NOV03 Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction in Both Phase 3 Trials
VAUGHAN, Ontario, LAVAL, Quebec, and HEIDELBERG, Germany, May 3, 2022 – Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that data from the second pivotal Phase 3 trial (MOJAVE) of investigational treatment NOV03 (perfluorohexyloctane) were presented virtually yesterday 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,” said Joseph C. Papa, chairman and CEO, Bausch Health. “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.”
DED is one of the most common ocular surface disorders, causing discomfort for an estimated 16 million Americans. MGD is a major cause of the development and progression of evaporative DED, which is caused by a deficient tear film lipid layer that leads to increased tear evaporation.1,2 In one student, it was found that approximately 86% of patients with DED have MGD involvement.3
The data presented from the Phase 3, multicenter, randomized, hypotonic saline-controlled, double masked study 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 efficacy endpoints, NOV03 continues to appear well tolerated in this population,” said John Sheppard, M.D., president, Virginia Eye Consultants, professor of Ophthalmology, Eastern Virginia Medical School, Norfolk, Va., and NOV03 trial investigator. “Treatment options for dry eye disease associated with Meibomain gland dysfunction in the United States are currently limited to methods, such as medical devices, warm compresses, lid scrubs and massage. If approved, NOV03 would offer eye care professionals a promising new therapeutic approach for these patients.”4
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 hyptonic saline solution four times daily (n=311 NOV03; n=309 saline). Key points from 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 (-2.3 [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 study, 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%).
“With these results reaffirming the safety and efficacy of NOV03 as a potential treatment option for dry eye disease associated with Meibomian gland dysfunction, we are one step closer to to making this potential novel treatment option available for patients in the United States,” said Christian Roesky, Ph.D., 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.”
About NOV03 (perfluorohexyloctane) Ophthalmic Solution
NOV03 is an investigational, proprietary, water-free, single-component preservative-free eye drop. 5 In 2019, Bausch Health and Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 in the United States and Canada. The clinical development program for NOV03 is expected to conclude with an ongoing multi-center, open-label, single-arm, 12-month safety extension
Novaliq is a biopharmaceutical company focusing on the development and commercialization of firstand best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology. Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of patients with eye diseases. Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on www.novaliq.com.
About Bausch + Lomb
Bausch + Lomb, a leading global eye health business of Bausch Health Companies, Inc., is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with more than 12,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on Twitter, LinkedIn, Facebook and Instagram.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of
pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
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- 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.
- 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.
- Lemp, M. A., Crews, L. A., Bron, A. J., Foulks, G. N., & Sullivan, B. D. (2012). Distribution of aqueousdeficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea, 31(5), 472–478. https://doi.org/10.1097/ICO.0b013e318225415a.
- 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.
- 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.