FDA Approves Bausch + Lomb Alaway Preservative Free Ophthalmic Solution

Bausch Health, Bausch + Lomb, and Eton Pharmaceuticals 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.