-- XEN® Becomes the First Medical Product
Approved by Using Real World Evidence in China --
DUBLIN, April 2, 2020 /PRNewswire/ -- Allergan plc
(NYSE: AGN) today announced China's National Medical Products
Administration (NMPA) approved the registration of Allergan's
XEN® Gel Stent on March 26,
2020 for the surgical management of patients with refractory
glaucoma. XEN® is the first product to be approved
in China through the Real World
Evidence pathway.
To boost the reform of China's
medical device approval process and explore the value of the Real
World Evidence pathway, the NMPA and Hainan Provincial Government
jointly initiated a Real World Evidence pilot program in
Hainan in June 2019.
Allergan partnered with the Hainan Boao Lecheng International
Medical Tourism Pilot Zone and obtained permission to use
XEN® in clinical practice at the Lecheng Pilot Zone in
April 2019 in accordance with the
policy for urgently needed imported medical devices.
When combined with data from controlled clinical trials
conducted outside China, the real
world evidence data collection in Hainan
Province enabled the assessment of ethnic differences to
treatment with XEN® and supported approval by the NMPA.
Real world evidence is the clinical evidence regarding the usage
and potential benefits or risks of a medical product from analysis
of real world data. Real world evidence can be generated by
different study designs or analyses, including randomized
trials.
"We are honored that XEN® has become the first
medical product approved in China
using real world evidence," said David
Nicholson, EVP and Chief R&D Officer at Allergan.
"As a global biopharmaceutical and medical device leader,
Allergan has a broad product offering and a deep R&D pipeline.
We are committed to improving the accessibility of our innovative
products and working with local and national officials to speed
their introduction into China to
address unmet needs of Chinese physicians and patients."
Glaucoma is one of the leading causes of blindness. Research
shows that the number of glaucoma patients in China would exceed 2.2 million by 2020.
Glaucoma is one of the primary causes of irreversible vision
loss and blindness.i An estimated 70 million people
globally are living with glaucoma.ii
XEN® is approved in more than 30 countries and
provides a new therapy for refractory glaucoma patients in
China. The XEN® System
is used by ophthalmologists for the surgical management of
refractory glaucomas, including cases where previous surgical
treatment did not work, cases of primary open-angle glaucoma, and
cases of pigmentary glaucoma with open angles that are unresponsive
to maximum tolerated medical therapy.
"XEN® has filled a gap in minimal invasive glaucoma
surgery in China and provides a
convenient, safe and effective treatment for glaucoma patients and
doctors. We believe it will help advance the innovation and
development of ophthalmology in China," said Dr. Sun Xinghuai, Chief of the
Ophthalmology Department at the Eye and ENT Hospital of Fudan
University, and Dr. Wang Ningli, Director of the Ophthalmology
Center at Beijing Tongren Hospital.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical
leader focused on developing, manufacturing and commercializing
branded pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world. Allergan markets a
portfolio of leading brands and best-in-class products primarily
focused on four key therapeutic areas including medical aesthetics,
eye care, central nervous system and gastroenterology. As part of
its approach to delivering innovation for better patient care,
Allergan has built one of the broadest pharmaceutical and device
research and development pipelines in the industry.
With colleagues and commercial operations located 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 on existing trends and
information as of the date of this release. 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; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated
with divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
projected synergies, restructurings, increased costs, and adverse
tax consequences; 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, 2019.
Except as expressly required by law, Allergan disclaims any intent
or obligation to update these forward-looking statements.
i World Health Organization. (2011). Glaucoma is
second leading cause of blindness globally. Retrieved from
https://www.who.int/bulletin/volumes/82/11/feature1104/en/
ii Quigley, H. A. (1996). Number of people with
glaucoma worldwide. Retrieved from
https://www.glaucoma.org/glaucoma/facts-statistics/glaucoma-facts-and-stats.php
CONTACTS:
Allergan:
Investors:
Manisha Narasimhan, PhD
(862)
261-7488
Media Relations:
Lisa Brown
(862) 261-7320
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