LAVAL, Quebec, Nov. 24, 2020 /CNW/ -- Bausch Health
Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company")
and Bausch + Lomb, its leading global eye health
business, announced today that the Company has initiated the
second of two Phase 3 studies evaluating the investigational
treatment NOV03 (perfluorohexyloctane) as a first-in-class
investigational drug with a novel mechanism of action to treat the
signs and symptoms of Dry Eye Disease (DED) associated with
Meibomian gland dysfunction (MGD). Enrollment of the first Phase 3
study is currently underway and has reached 85% of its enrollment
goal.
NOV03 is an investigational, proprietary, water-free and
preservative-free solution, based on patented EyeSol® technology
from Novaliq GmbH1. DED is a chronic and serious disease
of the ocular surface2. In a Phase 2 study of 336
patients, NOV03 met its primary efficacy endpoint of statistically
significant improvement of total corneal fluorescein staining over
control at eight weeks. In addition, NOV03 showed statistically
significant improvement of certain symptoms, such as severity and
frequency of dryness and burning/stinging of the eyes, over the
entire duration of the Phase 2 study with no notable safety
events.
"Bausch + Lomb, our global eye health business, is focused on
researching and bringing forward new options for unmet medical
needs, including Dry Eye Disease associated with MGD. It's
estimated that more than 16 million Americans suffer from Dry Eye
Disease3, and if approved, NOV03 may be the first
pharmaceutical therapy available for U.S. patients who have Dry Eye
Disease associated with MGD," said Joseph
C. Papa, chairman and CEO of Bausch Health.
About Bausch + Lomb
Bausch + Lomb, a leading global
eye health business of Bausch Health Companies Inc., is solely
focused on helping people see. Its core businesses include
over-the-counter products, dietary supplements, eye care products,
ophthalmic pharmaceuticals, contact lenses, lens care products,
ophthalmic surgical devices and instruments. Bausch + Lomb
develops, manufactures and markets one of the most comprehensive
product portfolios in the industry, which is available in
approximately more than 100 countries. For more information, visit
www.bausch.com.
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. More information can be found at
www.bauschhealth.com.
Forward-looking Statements
This news release may
contain forward-looking statements, which may generally be
identified by the use of the words
"anticipates," "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 the 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, 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.
© 2020 Bausch & Lomb Incorporated or its
affiliates.
1 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.
2 Lemp et al. Distribution of Aqueous-Deficient
and Evaporative Dry Eye in a Clinic-Based Patient Cohort: A
Retrospective Study. Cornea. 2012;31:472–478.
3 Farrand et al. Prevalence of Diagnosed Dry Eye
Disease in the United States Among
Adults Aged 18 Years and Older. Am J Ophthalmol 2017;
182:90–98.
Investor
Contact:
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Media
Contact:
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Arthur
Shannon
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Lainie
Keller
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arthur.shannon@bauschhealth.com
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lainie.keller@bauschhealth.com
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(514)
856-3855
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(908)
927-1198
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(877) 281-6642 (toll
free)
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SOURCE Bausch Health Companies Inc.