Allergan: FDA Accepts For Filing 510(k) Premarket Notification For XEN Glaucoma

(RTTNews) - Irish pharmaceutical company Allergan plc (AGN) announced Wednesday that the U.S. Food and Drug Administration has accepted for filing the 510(k) Premarket Notification Application for the XEN Glaucoma Treatment System -consisting of the XEN45 Gel Stent and the XEN Injector.

XEN45 is a minimally invasive implantable crosslinked gelatin shunt used to reduce intraocular pressure or IOP associated with refractory glaucoma.

XEN45 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.

David Nicholson, Chief R&D Officer, at Allergan, said, "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."

Glaucoma is a group of diseases that damage the eye's optic nerve and can result in vision loss and blindness.