Allergan Wins FDA Nod for the XEN Gel Stent, a New Surgical Treatment for Refractory Glaucoma
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:
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(862) 261-7152
Media:
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(201) 273-4724
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