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
trial (KALAHARI).

About Novaliq

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.

Forward-looking Statements

This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch Health’s most recent annual report on Form 10-K and detailed from time to time in Bausch Health’s other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development
timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

References

  • 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.

FDA accepts NDA filing for NOV03

VAUGHAN, Ontario, and HEIDELBERG, Germany, Sept. 6, 2022 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for investigational treatment NOV03 (perfluorohexyloctane). A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). NOV03 has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

Dermaliq Therapeutics Announces First Patient Dosed in Phase 1b/2 Trial Evaluating DLQ02 for Treatment of Plaque Psoriasis

Wilmington, Delaware, August 18, 2022 – Dermaliq Therapeutics, Inc. (Dermaliq), a private, clinical stage pharmaceutical company with a focus on dermatology, today announced first patient dosed in a Phase 1b/2a trial with DLQ02, a topical calcineurin inhibitor. The trial is designed to evaluate the safety, systemic absorption, pharmacodynamics, and clinical efficacy of DLQ02 in patients with plaque psoriasis.

Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®

Heidelberg, Germany, and Cambridge, MA, USA, August 09, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for CyclASol® (cyclosporine ophthalmic solution), a proposed novel treatment for the signs and symptoms of dry eye disease (DED).

Bausch + Lomb and Novaliq Announce Submission of New Drug Application for Investigational Treatment NOV03 (Perfluorohexyloctane)

VAUGHAN, Ontario, and HEIDELBERG, Germany, July 7, 2022 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced the submission of a New Drug Application (NDA) at the end of June to the U.S. Food and Drug Administration (FDA) seeking approval for NOV03 (perfluorohexyloctane), an investigational treatment with a proposed indication of treating the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).

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