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November 23, 2016

FDA clears Allergan’s XEN Glaucoma Treatment System

Allergan has obtained the US Food and Drug Administration (FDA) approval for its XEN Glaucoma Treatment System.

Allergan has obtained the US Food and Drug Administration (FDA) approval for its XEN Glaucoma Treatment System.

The system 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 not responsive to maximum tolerated medical therapy.

Implanted through an ab interno approach, the Xen reduces IOP by creating a new drainage channel with a permanent implant that becomes flexible.

"Studies have shown that at 12 months using XEN, patients used, on average, less IOP lowering drops than they did before XEN was implanted."

The XEN Glaucoma Treatment System consists of XEN45 Gel Stent and the XEN Injector, are designed to reduce intraocular pressure (IOP) in patients.

The XEN Gel Stent is made of a gelatin derived from porcine dermis which is then formed into a tube, and then cross-linked with glutaraldehyde.

When hydrated, the gelatin expands and becomes flexible which supports the retention of the Gel Stent in its intended location after surgical implantation.

The XEN Injector is a single use mechanical delivery system for the preloaded XEN Gel Stent enabling the surgeon to advance and deliver the Gel Stent to the desired location.

University of California professor of Ophthalmology Robert Weinreb said: "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."

The treatment system has demonstrated efficacy in reducing IOP in refractory glaucoma patients during the US pivotal trial.

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