Bausch Health Companies Inc.
Bausch Health Companies Inc. issued the following announcement on September 25.
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. Preservatives commonly used in eye drops can cause allergic reactions in some people that can lead to redness, irritation, itching or tearing.
"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.
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