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# Allergan Files 510(k) for Glaucoma Treatment System
- URL: https://www.fdaweb.com/allergan-files-510-k-for-glaucoma-treatment-system/
- Published: 2016-06-15T12:00:00.000Z
- Updated: 2026-09-14T21:09:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135949

FDA has accepted an Allergan 510(k) for the XEN Glaucoma Treatment System (comprising the XEN45 Gel Stent and the XEN Injector). The implantable crosslinked gelatin shunt is intended for use to reduce intraocular pressure associated with refractory glaucoma, according to the company. The device is CE marked in the European Union, where it is indicated for reducing 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.

Glaucoma is a group of diseases that damage the eye’s optic nerve and can result in vision loss and blindness. In open-angle glaucoma, even though an ocular fluid drainage angle is “open,” the fluid passes too slowly through a meshwork drain, according to the company. When the fluid builds up, the pressure inside the eye rises to a level that may damage the optic nerve, it says.