Allergan Gets FDA Acceptance of Premarket Notification Filing for the XEN Glaucoma Treatment System

Allergan plc

revealed Wednesday that the 510(k) Premarket Notification Application for its XEN Glaucoma Treatment System, which consisted of the XEN45 Gel Stent and the XEN Injector, was accepted for filing by the Food and Drug Administration (FDA). According to the company, XEN45 is a minimally invasive implantable crosslinked gelatin shunt used to reduce intraocular pressure (IOP) associated with refractory glaucoma. Allergan said that XEN45 is CE marked in the European Union, where it was indicated for the reduction of intraocular pressure in patients with primary open angle glaucoma where earlier medical treatments have not succeeded. It was also licensed for use in Canada, Switzerland, and Turkey. The company's Chief R&D Officer, David Nicholson, commented, "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." The stock advanced 0.23 percent on Tuesday.