Allergan (NYSE:AGN) said today that it won FDA approval for its Xen gel stent and injector for glaucoma. The federal watchdog indicated the drug device for the management of refractory glaucoma, in cases where surgical treatment has failed or in patients with open angle glaucoma that is unresponsive to maximum tolerated medical therapy.
The Dublin-based company’s device is implanted ab interno, reducing intraocular pressure by forming a new drainage channel with a flexible, permanent implant.
In a pivotal trial conducted in the U.S., the device reduced intraocular pressure from a mean medicated baseline of 25.1 mmHg to 15.9mmHg at the 1 year visit in patients with refractory glaucoma. Patients who used the device also used less intraocular pressure-lowering medications after 1 year.
“Xen is a new option that provides an opportunity for surgical intervention in refractory glaucoma patients. Xen can effectively lower IOP, in fact, studies have shown that at 12 months using Xen, patients used, on average, less IOP lowering drops than they did before Xen was implanted,” Dr. Robert Weinreb, of the University of California-San Diego, said in prepared remarks.
The company reported that it expects a U.S. launch in early 2017. The device is CE Marked in the E.U. and is licensed for use in Canada, Switzerland and Turkey.
“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,” chief R&D officer David Nicholson added. “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.”