China Gives Greenlight to Allergan's XEN® Registration for the Surgical Management of Refractory Glaucoma
-- 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
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