DUBLIN, Nov. 22, 2016 /PRNewswire/ -- Allergan plc
(NYSE: AGN) announced today the U.S. Food and Drug
Administration (FDA) has cleared the XEN®
Glaucoma Treatment System (consisting of the XEN45 Gel Stent and
the XEN Injector) for use in the U.S. The XEN Glaucoma Treatment
System reduces intraocular pressure (IOP) in patients and is
indicated for the management of refractory glaucomas, where
previous surgical treatment has failed or in patients with primary
open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma
with open angles that are unresponsive to maximum tolerated medical
therapy. XEN is implanted through an ab interno approach and
reduces IOP by creating a new drainage channel with a permanent
implant that becomes flexible. This provides a new treatment option
for the millions of Americans with refractory glaucoma.
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"Allergan has a deep, long-term commitment to developing
treatments for patients with glaucoma, a sight-threatening disease
that affects millions in the United
States and worldwide. We are thrilled to receive FDA
clearance for the XEN Glaucoma Treatment System, which will provide
a new treatment option for patients struggling to bring down their
intraocular pressure," said David
Nicholson, Chief R&D Officer at Allergan.
In the U.S. pivotal trial conducted in refractory glaucoma
patients, XEN reduced IOP from a mean medicated baseline of 25.1 (+
3.7) mmHg to 15.9 (+ 5.2) mmHg at the 12 month visit (n=52). The
mean baseline number of IOP-lowering medications was 3.5 (± 1.0)
versus an average use of 1.7 (± 1.5) medications at 12 months. XEN
also allows for keeping post-operative options open, allowing
physicians to utilize other IOP-reduction techniques in the event
that they are still needed after surgery.
"XEN is a new option that provides an opportunity for surgical
intervention in refractory glaucoma patients. XEN can effectively
lower IOP, in fact, studies have shown that at 12 months using XEN,
patients used, on average, less IOP lowering drops than they did
before XEN was implanted," said Robert N.
Weinreb, M.D., chairman and distinguished professor of
Ophthalmology at the University of California,
San Diego.
Allergan plans to launch the XEN Glaucoma Treatment System in
the U.S. in early 2017. More than 10,500 XEN Gel Stents have
already been distributed worldwide. XEN 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.
About XEN
INDICATIONS
The XEN® Glaucoma Treatment
System is indicated for the management of refractory glaucomas,
including cases where previous surgical treatment has failed, cases
of primary open-angle glaucoma, and pseudoexfoliative or pigmentary
glaucoma with open angles that are unresponsive to maximum
tolerated medical therapy.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
XEN® Gel Stent is
contraindicated in angle-closure glaucoma where angle has not been
surgically opened, previous glaucoma shunt/valve or conjunctival
scarring/pathologies in the target quadrant, active iris
neovascularization, anterior chamber IOL, intraocular silicone oil,
and vitreous in the anterior chamber.
WARNINGS
XEN® Gel Stent complications may
include choroidal effusion, hyphema, hypotony, implant migration,
implant exposure, wound leak, need for secondary surgical
intervention, and intraocular surgery complications. Safety and
effectiveness in neovascular, congenital, and infantile glaucoma
has not been established. Avoid digital pressure following
implantation of the XEN® Gel Stent to avoid implant
damage.
PRECAUTIONS
Examine the XEN® Gel Stent and
XEN® Injector in the operating room prior to use.
Monitor IOP postoperatively and if not adequately maintained,
manage appropriately. Stop the procedure immediately if increased
resistance is observed during implantation and use a new
XEN® system. Safety and effectiveness of more than a
single implanted XEN® Gel Stent has not been
studied.
ADVERSE EVENTS
The most common postoperative adverse
events included BCVA loss of > 2 lines (< 30 days 15.4%; >
30 days 10.8%; 12 months 6.2%), hypotony IOP < 6 mm Hg at any
time (24.6%; no clinically significant consequences were
associated, no cases of persistent hypotony, and no surgical
intervention was required), IOP increase > 10 mm Hg from
baseline (21.5%), and needling procedure (32.3%).
Caution: Federal law restricts this device to sale by or on the
order of a licensed physician.
For full product information call 1-800-678-1605 and to report
an adverse event 1-800-433-8871.
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
i National Eye Institute – Glaucoma Facts:
https://nei.nih.gov/health/glaucoma/glaucoma_facts
ii Bright Focus Foundation – Glaucoma Facts & Figures:
http://www.brightfocus.org/glaucoma/article/glaucoma-facts-figures
About Allergan plc
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland,
is a bold, global pharmaceutical company and a leader in a new
industry model – Growth Pharma. Allergan is focused on
developing, manufacturing and commercializing branded
pharmaceuticals, devices and biologic products for patients around
the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's
R&D model, which defines our approach to identifying and
developing game-changing ideas and innovation for better patient
care. This approach has led to Allergan building one of the
broadest development pipelines in the pharmaceutical industry with
70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global
colleagues' commitment to being Bold for Life. Together, we
build bridges, power ideas, act fast and drive results for our
customers and patients around the world by always doing what is
right.
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 every day.
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
September 30, 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.
CONTACTS:
Investors :
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(973) 906-1526
Suzanne Jacobson
(201) 273-4724
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SOURCE Allergan plc