FDA Approves XEN Glaucoma Treatment System
Allergan announced that the Food and Drug Administration (FDA) has approved the Xen Glaucoma Treatment System for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open-angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.
The Xen Glaucoma Treatment System consists of the Xen45 Gel Stent and the Xen Injector. It is implanted via an ab-interno route and decreases intraocular pressure (IOP) by creating a new drainage channel with a flexible yet permanent implant. The System allows opportunities for post-operative intervention if the patient still requires IOP reduction after surgery.
A study (n=52) conducted in 2015 by Rohit Varma, MD, MPH, of the University of Southern California Roski Eye Institute, found that eye pressure decreased by 44% in patients 1 year after the implant. IOP was reduced from a mean medicated baseline of 25.1mmHg to 15.9mmHg. Also, the use of IOP medications was decreased by 65%. The mean baseline number of IOP-lowering medications was 3.5 compared to an average of 1.7 medications at 1 year after the implant.
The Xen Glaucoma Treatment System will be available in early 2017.