FDA Approves Preservative-Free Ophthalmic Solution for Eye Allergy Itch

September 25, 2020

Ketotifen fumarate ophthalmic solution 0.035% is the first and only over-the-counter preservative-free eye drop solution for itchy eyes caused by allergies.

The US Food and Drug Administration (FDA) has approved ketotifen fumarate ophthalmic solution 0.035% (Alaway) antihistamine eye drops (EM-100) as the first over-the-counter preservative-free formulation eye drop for the treatment of itchy eyes caused by allergies.

The approval, granted to Bausch + Lomb and Eton Pharmaceuticals, is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair, and dander in adults and children ≥3 years.

About 80% of people with allergies experience itchy eyes as one of their symptoms. Preservatives that are commonly used in eye drops can lead to an allergic reaction, thus causing redness, irritation, itching, or tearing.

Alaway has been formulated to relieve eye itch within minutes. Furthermore, with only 1 dose, the eye drop is able to provide up to 12 hours of relief.

"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 of Eton Pharmaceuticals, in a statement.

According to Joe Gordon, the US president of Bausch + Lomb, the ophthalmic solution is anticipated to reach the market by Spring 2021, in time for the onset of allergy season.