LAVAL, QC and DEER PARK,
Ill., Sept. 25, 2020
/PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC)
("Bausch Health"), Bausch + Lomb, a leading global eye health
business, and Eton Pharmaceuticals, Inc. (NASDAQ: ETON) today
announced that the U.S. Food and Drug Administration (FDA) has
approved Alaway® Preservative Free (ketotifen fumarate) ophthalmic
solution, 0.035%, antihistamine eye drops (EM-100), as the first
over-the-counter (OTC) preservative-free formulation eye drop
approved to temporarily relieve itchy eyes due to pollen, ragweed,
grass, animal hair and dander, which is one of the eye symptoms
that affects approximately 80 percent of people with
allergies.[1] Preservatives commonly used in eye
drops can cause allergic reactions in some people that can lead to
redness, irritation, itching or tearing.[2],[3]
"We're excited to add Alaway Preservative Free – the first and
only OTC preservative-free formulation eye drop of its kind – to
our existing Bausch + Lomb Consumer Health Care portfolio. Alaway
Preservative Free can provide up to 12 hours of relief for people
suffering from itchy eyes due to certain eye allergies," said
Joe Gordon, U.S. president, Bausch +
Lomb. "We expect Alaway Preservative Free will be available for
purchase in the Spring of 2021 at major retailers in time for the
start of allergy season."
Alaway® Preservative Free is indicated for
the temporary relief of itchy eyes due to pollen, ragweed,
grass, animal hair and dander in adults and children 3 years of age
and older. It is formulated to relieve eye itch within minutes and
can provide up to 12 hours of eye itch relief with one dose.
"We are pleased the FDA has approved Alaway Preservative Free,
and we look forward to collaborating with Bausch + Lomb to bring
this unique eye drop to patients suffering from itchy eyes
associated with eye allergies," said Sean
Brynjelsen, CEO, Eton
Pharmaceuticals.
An affiliate of Bausch Health acquired the U.S. rights to Alaway
Preservative Free from Eton in 2019.
About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc.
is a specialty pharmaceutical company focused on developing,
acquiring, and commercializing innovative products. Eton is
primarily focused on hospital injectable and pediatric rare disease
products. The company's first commercial product, Biorphen, is the
only FDA approved ready-to-use formulation of phenylephrine
injection and was launched in December
2019. The company's lead pediatric product is the orphan
drug Alkindi® Sprinkle, which is currently under review with the
FDA. For more information, visit www.etonpharma.com.
About Bausch + Lomb
Bausch + Lomb, a leading global
eye health business of Bausch Health Companies Inc., is solely
focused on helping people see better. 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 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 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.
Alaway is a trademark of Bausch & Lomb Incorporated or
its affiliates.
© 2020 Bausch & Lomb
Incorporated or its affiliates.
APF.0015.USA.20
[1] The 2018 U.S. Study of Allergies, Multi-sponsor
Surveys, Inc. February 2018.
[2] Baudouin C. The Ocular Surface in Glaucoma, Cornea, Volume
28, Number 9, Suppl. 1, October
2009.
[3] Baudouin C. Allergic reaction to topical eye drops. Curr
Opin Allergy Clin Immunol. 2005;5:459–63.
Eton Investor and Media Contact:
David Krempa
dkrempa@etonpharma.com
612-387-3740
Bausch Health Investor Contact:
Arthur
Shannon
arthur.shannon@bauschhealth.com
(514) 856-855
(877) 281-6642 (toll free)
Bausch Health Media Contact:
Lainie Keller
lainie.keller@bauschhealth.com
(908) 927-1198
View original content to download
multimedia:http://www.prnewswire.com/news-releases/fda-approves-bausch--lomb-alaway-preservative-free-ketotifen-fumarate-ophthalmic-solution-0-035-301138158.html
SOURCE Bausch Health Companies Inc.