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Alcon announces FDA approval of the O-T-C switch of Pataday Once Daily Relief Extra Strength

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GENEVAAlcon announced Tuesday that Pataday Once Daily Relief Extra Strength (olopatadine hydrochloride ophthalmic solution 0.7%), formerly prescribed as Pazeo, has been approved by the Food and Drug Administration (FDA) for sale over-the-counter (O-T-C) in the United States. Pataday Once Daily Relief Extra Strength is the first and only once daily eye allergy itch drop offering a full 24 hours of relief without a prescription. Allergies are the sixth-leading cause of chronic illness in the U.S., generating approximately $2.7 billion in O-T-C retail sales.

“Alcon is thrilled to bring another needed innovation to the millions of people in the U.S. who suffer from itchy allergy eyes,” said Sergio Duplan, region president of North America at Alcon. “With Pataday Once Daily Relief Extra Strength, eye allergy sufferers will get over-the-counter eye allergy itch relief that lasts a full 24 hours. We’re excited to bring more customer options to the Pataday product portfolio, which is already the number one eye allergy brand in the U.S. O-T-C market.”

This formulation joins Pataday Once Daily Relief (olopatadine hydrochloride ophthalmic solution 0.2%) and Pataday Twice Daily Relief (olopatadine hydrochloride ophthalmic solution 0.1%), which were approved for sale over-the-counter in February 2020. The Pataday brand contains olopatadine, the No. 1 doctor prescribed active ingredient for eye allergy relief. Since 2008, over 40 million prescriptions have been written for olopatadine.

“The active ingredient in Pataday has been my ‘go-to’ for years. I’m thrilled that an extra strength option will be available over-the-counter to give even more patients access to a full 24 hours of relief for itchy allergy eyes. I look forward to sending my patients with ocular allergies to the shelf to find the full range of relief options now offered by the Pataday family of products,” said Dr. Michael Cooper, Solinsky EyeCare, West Hartford, Conn.

Alcon secured the rights to switch prescription products using the active ingredient olopatadine to OTC as part of its separation from Novartis in April 2019. Both Pataday Twice Daily Relief and Pataday Once Daily Relief are available now in all major food, drug and mass retailers nationally. Pataday Once Daily Relief Extra Strength will be available online beginning in September, ahead of national retail availability in February 2021. In the meantime, patients should speak with their doctor or pharmacy regarding existing prescription refills.


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