FDA Approves Bausch + Lomb’s Alaway, the First OTC Preservative-Free Eye Drop Approved for Treating Itchy Eyes Associated With Allergies

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LAVAL, Quebec and DEER PARK, Ill.—Bausch Health Companies Inc. (NYSE/TSX: BHC), Bausch + Lomb and Eton Pharmaceuticals (NASDAQ: ETON) jointly announced that the FDA has approved Alaway Preservative Free (ketotifen fumarate) ophthalmic solution, 0.035%, antihistamine eye drops (EM-100). The new drops will be “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,” according to the announcement. These are the the eye symptoms that affect approximately 80 percent of people with allergies, the statement noted.

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,” B+L’s U.S. president Joe Gordon said in the announcement. “Alaway Preservative Free can provide up to 12 hours of relief for people suffering from itchy eyes due to certain eye allergies. 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.

Eton Pharmaceuticals, which developed the eye drop, is collaborating with Bausch + Lomb to bring the eye drop to patients suffering from itchy eyes. An affiliate of Bausch Health acquired the U.S. rights to Alaway Preservative Free from Eton in 2019.