FDA Approves OTC Olopatadine Solutions for Eye Allergy Relief

The FDA has approved olopatadine hydrochloride ophthalmic solution 0.2% (Pataday Once Daily Relief, Alcon) and olopatadine hydrochloride ophthalmic solution 0.1% (Pataday Twice Daily Relief, Alcon) for sale as an OTC medication in the United States.

The Pataday brand features the number 1 doctor-prescribed eye allergy itch relief ingredient and includes the first once-daily allergy itch relief drop to be available without a prescription.

“At Alcon, we are focused on delivering new eye care products and solutions that meet the needs of patients and consumers, including those who suffer from allergies,” said Sergio Duplan, region president of North America at Alcon, in a press release. “We are proud to launch prescription-strength Pataday as a convenient, more easily accessible, [OTC] option to relieve the itchy eyes that almost 1-in-5 Americans experience due to ocular allergies.”

The rights to the Rx-to-OTC switch were secured by Alcon as part of its separation from Novartis in April 2019. Alcon will market both olopatadine 0.1% (Patanol Solution, Alcon) and olopatadine 0.2% (Pataday Solution, Alcon) under the Pataday brand name as Pataday Twice Daily Relief and Pataday Once Daily Relief, respectively.

Approximately 66 million Americans suffer from ocular allergies, but only 7 million use an OTC allergy eye drop to relieve their symptoms, according to Alcon. Because olopatadine 0.1% and 0.2% are OTC, more Americans will have access to prescription-strength relief from the itching associated with eye allergies.

Olopatadine 0.2% and olopatadine 0.1% are indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair, and dander for ages 2 years and older. Olopatadine 0.1% is also indicated for the temporary relief of red eyes.

US commercial availability of olopatadine 0.2% and olopatadine 0.1% will begin in early March and will be available in all major drug, food, and mass market retailers as well as through online retailers.

Reference

• Alcon to Launch Pataday, the Eye Allergy Drop with the #1 Doctor-Prescribed Active Ingredient, following FDA Approval of OTC Switch [news release]. Alcon website. Published February 17, 2020. https://www.alcon.com/media-release/alcon-launch-pataday-eye-allergy-drop-1-doctor-prescribed-active-ingredient-following. Accessed March 13, 2020.