Alcon Announces FDA Approval of the OTC Switch of Pataday Once Daily Relief Extra Strength
July 14 2020 - 7:50AM
Business Wire
- Pataday® Once Daily Relief Extra Strength (olopatadine 0.7%)
is the first and only eye allergy itch drop offering a full 24
hours of relief without a prescription in the U.S.1
- This formulation joins Pataday® Once Daily Relief
(olopatadine 0.2%) and Pataday® Twice Daily Relief (olopatadine
0.1%), which were approved for sale over-the-counter in February
2020.
- Pataday Once Daily Relief Extra Strength (olopatadine 0.7%),
formerly prescribed as Pazeo®, will be available online beginning
in September, ahead of national retail availability in early 2021.
In the meantime, patients should speak with their doctor or
pharmacy regarding existing prescription refills.
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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“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
- PAZEO® [package insert]. Fort Worth, TX: Alcon Inc; 2016
- Allergies: Gateway to Health Communication (CDC)
- Alcon. Data on file. 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
- IQVIA. Data on file. 2019.
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Investor Relations Christina
Cheng + 41 589 112 110 (Geneva) + 1 817 615 2789 (Fort Worth)
investor.relations@alcon.com
Media Relations Wes Warnock
+ 41 589 112 111 (Geneva) + 1 817 615 2501 (Fort Worth)
globalmedia.relations@alcon.com
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