Alcon Announces FDA Approval of the OTC Switch of Pataday Once Daily Relief Extra Strength

Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced 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 (OTC) 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.¹ Allergies are the sixth-leading cause of chronic illness in the U.S., generating approximately $2.7 billion in OTC retail sales.^2,3

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Pataday® Product Portfolio (Photo: Business Wire)

"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. OTC 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 #1 doctor prescribed active ingredient for eye allergy relief. Since 2008, over 40 million prescriptions have been written for olopatadine.⁶

"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 Michael S. Cooper, OD, Solinsky EyeCare, West Hartford, CT.

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. Visit Pataday24hour.com for more information.

About Ocular Allergies

Ocular allergies, or allergic conjunctivitis, is the most common allergy affecting the eyes.⁴ It occurs when the eye becomes exposed to seasonal airborne pollutants such as grass, tree pollen and mold spores.⁴ In addition, environmental effects such as pollution along with dust mites and animal dander in the home can also lead to allergic conjunctivitis.⁴ 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.⁵ Itchy eyes are the most common symptom of eye allergies.⁵

ABOUT ALCON

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.

Forward-looking Statements

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.

References

1. PAZEO^® [package insert]. Fort Worth, TX: Alcon Inc; 2016
2. Allergies: Gateway to Health Communication (CDC)
3. Alcon. Data on file. 2019.
4. AAAI Common Eye Symptoms Could be an Allergy
5. Ono SJ, Abelson MB. Allergic conjunctivitis: Update on pathophysiology and prospects for future treatment. J Allergy Clin Immunol. 2005;115(1):118-122
6. IQVIA. Data on file. 2019.

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