La FDA ha aprobado como tratamiento para el glaucoma refractario el Gel Stent XEN de la compañía farmacéutica Allergan.
El XEN está indicado para tratar los glaucomas refractarios incluyendo casos en los que la cirugía para dicha patología haya fracasado, incluídos los casos de glaucoma de ángulo abierto, pseudoexfoliativo, etc
The FDA has cleared Allergan’s XEN Gel Stent as a treatment for refractory glaucoma, the Dublin-based company announced Nov. 22.
The XEN is indicated 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.
Pivotal trial results showed that, on average, patients implanted with XEN used less IOP-lowering medications than before the device was implanted.
Twelve-month results from its pivotal trial showed that the XEN reduced IOP by 15.9 (+5.2) mmHg from a mean medicated baseline of 25.1 (+3.7) mmHG, Allergan said.
Allergan plans to launch its XEN treatment system, which includes the gel stent and an injector, in early 2017. It has already distributed 10,500 XEN Gel Stents worldwide, the company said.
Allergan acquired the rights to the XEN when it bought AqueSys for $300 million in September 2015.
The device has received CE marking in Europe, with an indication for patients with primary open-angle glaucoma where previous medical treatments have failed; the stent is also licensed for use in Canada, Switzerland, and Turkey.
Dr. Helmut Höh, chief physician in the ophthalmology department of Dietrich-Bonhoeffer-Klinikum in Neubrandenburg, Germany, said at the ESCRS meeting in Copenhagen in September 2016 that doctors in his hospital use the XEN as a last resort before trabeculectomy in patients whose IOP has not been controlled by the iStent or CyPass.