DUBLIN, June 15, 2016 /PRNewswire/ -- Allergan plc
(NYSE: AGN) announced today that the 510(k) Premarket Notification
Application for the XEN Glaucoma Treatment System (consisting of
the XEN45 Gel Stent and the XEN Injector) has been accepted for
filing by the U.S. Food and Drug Administration (FDA). XEN45 is a
minimally invasive implantable crosslinked gelatin shunt used to
reduce intraocular pressure (IOP) associated with refractory
glaucoma.
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XEN45 is CE marked in the European Union, where it is indicated
for the reduction of intraocular pressure in patients with primary
open angle glaucoma where previous medical treatments have failed.
It is also licensed for use in Canada, Switzerland, and Turkey.
"We are pleased that the FDA has accepted the 510(k) filing for
the XEN Glaucoma Treatment System, an excellent complement to
Allergan's ongoing portfolio and development programs in this
critical treatment area. We look forward to working together with
the FDA to bring this treatment to market and, in doing so, offer a
potential new option to millions of Americans who suffer from
glaucoma," said David Nicholson,
Chief R&D Officer, at Allergan.
About Glaucoma
Glaucoma is a group of diseases that damage the eye's optic
nerve and can result in vision loss and blindness.i
Several large studies have shown that eye pressure is a major risk
factor for optic nerve damage.i In open-angle
glaucoma, even though an ocular fluid drainage angle is "open", the
fluid passes too slowly through a meshwork drain.i When
the fluid builds up, the pressure inside the eye rises to a level
that may damage the optic nerve.i When the optic
nerve is damaged from increased pressure, open-angle glaucoma-and
vision loss may result.i In 2010, 60.5 million
people globally were living with glaucoma.ii Given
the aging of the world's population, the number of people living
with glaucoma may increase to nearly 80 million by
2020.ii
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 (certain of 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.
For more information, visit Allergan's website at
www.allergan.com.
i National Eye Institute – Glaucoma
Facts: ttps://nei.nih.gov/health/gla...
ii Bright Focus Foundation – Glaucoma Facts &
Figures: ttp://www.brightfocus.org/gla...
CONTACTS:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(973) 906-1526
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SOURCE Allergan plc