Preservative-free antihistamine drops gain FDA clearance

The FDA has approved the first preservative-free, over-the-counter antihistamine drops for allergic conjunctivitis. Ketotifen fumarate 0.035% (Alaway Preservative Free) is indicated for adults and children aged 3 years or older.

According to a press release from Bausch Health, a single dose of the drug can provide up to 12 hours of relief to itchy eyes caused by pollen, ragweed, grass, animal hair and dander.

The decision comes after the FDA initially rejected the drops in July 2019—just a few months after Bausch Health acquired the drops from Eton Pharmaceuticals—without citing concerns about clinical data.

According to the latest press release, the drug should hit markets by spring 2021, just in time for the next allergy season.