FDA OKs Preservative-Free OTC Eye Drops for Allergy Symptoms

September 29, 2020

The FDA has approved OTC ketotifen fumarate (Alaway Preservative Free; Bausch + Lomb and Eton Pharmaceuticals) ophthalmic solution, 0.035% antihistamine eye drops.

The FDA has approved OTC ketotifen fumarate (Alaway Preservative Free; Bausch + Lomb and Eton Pharmaceuticals) ophthalmic solution, 0.035% antihistamine eye drops (EM-100), according to the press release.

Ketotifen fumarate ophthalmic solution, 0.035%, is the first OTC preservative-free formulation eye drop to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander. Preservatives commonly used in eye drops can cause allergic reactions that can lead to redness, irritation, itching, or tearing.

The eye drop is indicated for use in adults and children aged 3 years and older. It is formulated to relieve eye itch within minutes and can provide up to 12 hours of eye itch relief with 1 dose.

“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,” Joe Gordon, US president of Bausch + Lomb, said in a statement. “Alaway Preservative Free can provide up to 12 hours of relief for people suffering from itchy eyes due to certain eye allergies.”

The product is expected to be available for purchase in spring of 2021 at major retailers in time for the start of allergy season.

Reference

FDA Approves Bausch + Lomb Alaway® Preservative Free (Ketotifen Fumarate) Ophthalmic Solution, 0.035%. News release. Eton Pharmaceuticals; September 25, 2020. Accessed September 29, 2020. https://ir.etonpharma.com/news-releases/news-release-details/fda-approves-bausch-lomb-alawayr-preservative-free-ketotifen