Through the FDA prescription (Rx)-to-OTC switch process, olopatadine HCl ophthalmic solution 0.1% and 0.2% (Pataday Twice Daily Relief and Once Daily Relief, respectively; Alcon) will soon be available over-the-counter (OTC) for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair, or dander.1

According to Alcon, the products will be available OTC in time for spring allergy season. The once-daily solution will be the first once-daily eye-itch allergy-relief drop to be available without a prescription in the United States.1

The Rx-to-OTC switch is typically initiated by the manufacturer, based on data demonstrating that the drug is safe and effective for self-medication as directed in proposed labeling. The manufacturer must demonstrate that consumers can understand how to safely use the drug without the supervision of a health care professional.1

“As a result of the Rx-to-OTC switch process, many products sold over-the-counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” said Karen Mahoney, MD, acting deputy director of the FDA’s Office of Nonprescription Drugs, in a prepared statement. “Approval of a wider range of nonprescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription.”1

Olopatadine HCl ophthalmic solution 0.1% was first approved in 1996 as a prescription drug indicated for the treatment of signs and symptoms of allergic conjunctivitis. The once-daily ophthalmic solution was first approved in 2004, and was indicated for the treatment of ocular itching associated with allergic conjunctivitis.1 According to a press release from Alcon, over 40 million prescriptions have been written for olopatadine since 2008.2

As mast cell stabilizer eyedrops, the drugs function by preventing the release of histamine, thereby preventing or controlling allergic disorders.1

Approximately 66 million people suffer from ocular allergies in the US, but only 7 million use an OTC eye drop for their symptoms. A statement from Alcon said the company hopes to make OTC options more accessible for those Americans not using OTC treatment options.2

According to the American College of Allergy, Asthma, and Immunology, common eye allergy triggers include outdoor allergens such as pollens, indoor allergens such as pet dander, and irritants such as cigarette smoke. Mast cell stabilizer eyedrops must be used before exposure to an allergen in order to work.3

The FDA noted that consumers should read and follow the Drug Facts labels for the nonprescription products, and patients who currently take prescription versions of the products should consult their health care provider before switching.1


REFERENCES
  1. FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process [news release]. White Oak, MD; February 14, 2020. FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-three-drugs-nonprescription-use-through-rx-otc-switch-process. Accessed February 17, 2020.
  2. Alcon to Launch Pataday, the Eye Allergy Drop with the #1 Doctor-Prescribed Active Ingredient, following FDA Approval of OTC Switch [news release]. Geneva; February 17, 2020. Alcon website. https://www.alcon.com/media-release/alcon-launch-pataday-eye-allergy-drop-1-doctor-prescribed-active-ingredient-following. Accessed February 17, 2020.
  3. Eye Allergy; American College of Allergy, Asthma, & Immunology. ACAAI website. https://acaai.org/allergies/types/eye-allergy. Accessed February 17, 2020.