DUBLIN, July 18, 2016 /PRNewswire/ -- Allergan plc (NYSE:
AGN) announced today that it has filed with the U.S. Food and Drug
Administration (FDA) the de novo application for the Oculeve
Intranasal Tear Neurostimulator device. According to the FDA, this
process provides a pathway for medical devices for which general
and/or special controls provide a reasonable assurance of safety
and effectiveness, but for which there is no legally marketed
predicate device.
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This handheld stimulator was investigated for temporarily
increasing tear production upon activation in patients with dry eye
disease due to decreased tear production. Recently Allergan
announced that two pivotal trials of the Oculeve Intranasal Tear
Neurostimulator each met their effectiveness endpoints.
"The Oculeve Intranasal Tear Neurostimulator is an exciting
potential option for patients suffering from dry eye disease, and
we are pleased to have filed the de novo application with FDA that
will allow patients to gain access to this novel medical device,"
said David Nicholson, Chief R&D
Officer, at Allergan.
The Oculeve Intranasal Tear Neurostimulator will complement
Allergan's robust existing dry eye portfolio and provide physicians
with a significant opportunity to treat more patients through this
novel, device-based approach.
About Dry Eye Disease
Dry eye disease affects over 31 million people. It can be caused
by advanced age, contact lens wear, certain medications, eye
diseases, other medical conditions or environmental factors.
Without enough tears, the film protecting the eye can break down,
creating dry spots on the cornea.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives.
For more information, visit Allergan's website at
www.allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing
trends and information as of the date of this release. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements. Actual
results may differ materially from Allergan's current
expectations depending upon a number of factors
affecting Allergan's business. These factors include,
among others, the difficulty of predicting the timing or outcome
of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; difficulties or
delays in manufacturing; and other risks and uncertainties detailed
in Allergan's periodic public filings with
the Securities and Exchange Commission, including but not
limited to Allergan's Annual Report on Form 10-K for the
year ended December 31, 2015 and Quarterly Report on Form
10-Q for the quarter ended March 31, 2016 (such periodic
public filings having been filed under the "Actavis plc" name).
Except as expressly required by law, Allergan disclaims
any intent or obligation to update these forward-looking
statements.
CONTACTS:
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Investors:
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Lisa
DeFrancesco
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(862)
261-7152
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Media:
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Mark
Marmur
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(973)
906-1526
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Frances
DeSena
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(201)
427-8762
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SOURCE Allergan plc