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Allergan gets FDA approval for Xen glaucoma treatment system

Allergan has secured approval from the US Food and Drug Administration (FDA) for the XEN Gel Stent, a new surgical treatment for refractory glaucoma.

The system, which features Xen45 gel stent and Xen injector, has been developed for the management of refractory glaucomas.

It will reduce intraocular pressure (IOP) in patients through creating a new drainage channel. It will be implanted by using an ab interno approach.

The system will be used to treat refractory glaucomas in patients, where previous surgical treatment gets failed or with primary open angle glaucoma.

It will also be used to treat patients with pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy

The company intends to introduce the Xen glaucoma treatment system in the US in early next year.

In the European Union, the Xen system received CE mark approval to reduce IOP in patients with primary open angle glaucoma where previous medical treatments have failed.

In addition, the system was approved in Canada, Switzerland and Turkey.

Allergan chief R&D officer David Nicholson said: "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.”