Allergan touts FDA acceptance of 510(k) application for Xen IOP reducing gel shunt

Allergan (NYSE: AGN) said today the FDA accepted the 510(k) premarket notification application for its Xen glaucoma treatment gel stent system, which consists of the Xen45 gel stent and Xen injector.

The system is a minimally invasive implantable, crosslinked gelatin shunt designed to reduce intraocular pressure associated with refractory glaucoma, according to the company. The device is designed to treat glaucoma by shunting intra-ocular fluid from the anterior chamber of the eye into the sub-conjunctival space.

“We are pleased that the FDA has accepted the 510(k) filing for the XEN Glaucoma Treatment System, an excellent complement to Allergan’s ongoing portfolio and development programs in this critical treatment area. We look forward to working together with the FDA to bring this treatment to market and, in doing so, offer a potential new option to millions of Americans who suffer from glaucoma,”chief R&D officer David Nicholson said in a press release.

The Xen45 system has won CE Mark approval in the European Union, where it is indicated for the reduction of intraocular pressure in patients with primary open angle glaucoma for whom previous medical treatments have failed.

The device is also approved for use in Canada, Switzerland and Turkey, the company said.

Allergan picked up the Xen system last October with its $300 million, all-cash acquisition of AqueSys, original developer of the Xen soft glaucoma stent, in a deal that also includes unspecified milestone payments.

The company raised a $43.6 million Series D funding round and closed enrollment in U.S. clinical trial of the Xen Gel stent in January 2014. Allergan announced the deal last September.

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