Allergan Announces FDA Acceptance of the 510(k) Premarket Notification Filing for the XEN Glaucoma Treatment System

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: https://nei.nih.gov/health/gla... 
ⁱⁱ Bright Focus Foundation – Glaucoma Facts & Figures: http://www.brightfocus.org/gla...

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SOURCE Allergan plc

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