Allergan's (AGN) XEN GTS Cleared by U.S. FDA

November 22, 2016 7:35 AM EST

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Allergan plc (NYSE: AGN) announced 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.

"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.



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