-- An Ab Interno Approach to Reduce Intraocular Pressure in Patients with Refractory Glaucoma -

-- Allergan Plans to Launch XEN in the U.S. in Early 2017 --

2016年11月30日讯 /生物谷BIOON/ --艾尔健（Allergan）近日宣布美国食品和药物管理局（FDA）已批准该公司开发的XEN青光眼治疗系统，该系统适用于手术治疗失败或最大耐受剂量药物治疗无效的难治性青光眼患者，用于降低患者眼内压（IOP）。

XEN青光眼治疗系统由XEN45凝胶支架和XEN注射器组成，其中，XEN45凝胶支架是一种从明胶中提取的胶原制备而成的柔性分流器，长6毫米，宽仅一根头发丝。XEN45由眼科医生采用XEN注射器通过微创手术植入眼结膜下腔。一旦植入，XEN45能够有效促进液体由前房流出进入结膜下非解剖组织，降低眼内压（IOP），同时可防止与当前结膜下手术相关的张力减退（IOP过低）。

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.

"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.