Allergan plc, a global pharmaceutical company, announced that the 510(k) premarket notification application for the XEN glaucoma treatment system (consisting of the XEN45 Gel Stent and the XEN injector) has been accepted for filing by the US Food and Drug Administration (FDA). XEN45 is a minimally invasive implantable crosslinked gelatin shunt used to reduce intraocular pressure (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.
"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," said David Nicholson, chief R&D officer, at Allergan.
Glaucoma is a group of diseases that damage the eye's optic nerve and can result in vision loss and blindness. Several large studies have shown that eye pressure is a major risk factor for optic nerve damage. In open-angle glaucoma, even though an ocular fluid drainage angle is "open", the fluid passes too slowly through a meshwork drain. When the fluid builds up, the pressure inside the eye rises to a level that may damage the optic nerve. When the optic nerve is damaged from increased pressure, open-angle glaucoma-and vision loss may result. In 2010, 60.5 million people globally were living with glaucoma. Given the aging of the world's population, the number of people living with glaucoma may increase to nearly 80 million by 2020.