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. Logo - http://photos.prnewswire.com/prnh/20150612/222796LOGO "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 XENINDICATIONS 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.