GENEVA--(BUSINESS WIRE)--Regulatory News:
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced that Pataday Once Daily Relief® (olopatadine hydrochloride ophthalmic solution 0.2%) and Pataday Twice Daily Relief® (olopatadine hydrochloride ophthalmic solution 0.1%) have been approved by the Food and Drug Administration (FDA) for sale over the counter (OTC) in the U.S.1,2 The Pataday brand features the No. 1 doctor-prescribed eye allergy itch relief ingredient, and includes the first once daily allergy itch relief drop to be available without a prescription for the approximately 66 million Americans who suffer from eye allergies.1,2, 4-7
“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, North America at Alcon. “We are proud to launch prescription-strength Pataday as a convenient, more easily accessible, over-the-counter 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 Patanol Solution (olopatadine 0.1%) and Pataday Solution (olopatadine 0.2%) under the Pataday brand name as Pataday Twice Daily Relief and Pataday Once Daily Relief, respectively. Both strengths provide long-lasting, itchy eye relief that works in minutes.1,2
“While eye allergies impact millions of Americans, only a small percentage of those use over-the-counter allergy eye drops likely due to a lack of awareness of effective options that treat the problem at the source,” said Michael Cooper, OD, Solinsky Eye Care, Hartford, CT. “For years, olopatadine has been my ‘go-to’ eye drop for patients struggling with itchy allergy eyes and I’m thrilled they will now be able to get the same relief over the counter whenever they need it. My hope is that more allergy sufferers will discover the benefits of Pataday and add it to their medicine cabinet this spring allergy season and beyond.”
Pataday Once Daily Relief (olopatadine 0.2%) and Pataday Twice Daily Relief (olopatadine 0.1%) are indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander for ages 2 and older1,2. Pataday Twice Daily Relief (olopatadine 0.1%) is also indicated for the temporary relief of red eyes2. Since 2008, over 40 million prescriptions have been written for olopatadine, the active ingredient in Pataday.3
Approximately 66 million Americans (1 in 5) suffer from ocular allergies, but only 7 million use an over-the-counter allergy eye drop to relieve their symptoms.4-7 By making Pataday (0.1% and 0.2%) available over the counter, more Americans will have access to long-lasting, prescription-strength relief from the itching associated with eye allergies.1,2
U.S. commercial availability of Pataday Once Daily Relief and Pataday Twice Daily Relief will begin March 2 in time for the start of spring allergy season, and will be available in all major drug, food and mass market retailers – more than 40,000 stores – as well as through online retailers. The launch is supported by a multimillion-dollar media plan including a national TV advertising campaign and strong online presence to reach eye allergy sufferers.
Visit www.AboutPataday.com to learn more.
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “commitment,” “look forward,” “maintain,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict. Some of these factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements.
Forward-looking statements in this press release speak only as of the date they are made, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise.
About Ocular Allergies
Ocular allergies, or allergic conjunctivitis, is the most common allergy affecting the eyes.8 It occurs when the eye becomes exposed to seasonal airborne pollutants such as grass, tree pollen and mold spores.8 In addition, environmental effects such as pollution along with dust mites and animal dander in the home can also lead to allergic conjunctivitis. 8 In response to this irritation, the body’s immune system releases a chemical known as histamine that can cause eyes to itch or become irritated.9 Itchy eye is the most common symptom of eye allergies.9
Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning more than seven decades, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 20,000 associates are enhancing the quality of life through innovative products, partnerships with eye care professionals and programs that advance access to quality eye care. Learn more at www.alcon.com.
- PATADAY® [package insert]. Fort Worth, TX: Alcon Inc; 2010
- PATANOL® [package insert]. Fort Worth, TX: Alcon Inc; 2002
- IQVIA. Data on file. 2019.
- Gomes PJ. Trends in prevalence and treatment of ocular allergy. Curr Opin Allergy Clin Immunol. 2014; 14: 451-456.
- Singh, K, Axelrod S, Bielory L. The epidemiology of ocular and nasal allergy in the United States, 1988-1994.
- US Population Census 2019. 6. Nielsen Household Panel Data Feb. 2019.
- Nielsen Latest 52 weeks 2/6/2019
- AAAI Common Eye Symptoms Could be an Allergy
- Ono SJ, Abelson MB. Allergic conjunctivitis: Update on pathophysiology and prospects for future treatment. J Allergy Clin Immunol. 2005;115(1):118-122