XEN Gel Stent Receives Approval from Health Canada to Treat Glaucoma

AqueSys Inc. has received a Class 3 medical device license for the XEN Gel stent from Health Canada.

AqueSys has chosen Salient Medical Solutions as the Canadian distributor and commercialization is expected to begin immediately. The XEN Gel stent is intended to reduce intraocular pressure (IOP) in patients with primary open angle glaucoma where previous medical treatments have failed.

Glaucoma affects more than 400,000 Canadians and 67 million people worldwide according to the Glaucoma Research Society of Canada. The Canadian National Institute for the Blind identifies glaucoma as the second leading cause of vision loss in the country; more than 250,000 Canadians have primary open-angle glaucoma, the most common form of the disease.

Primary open angle glaucoma gradually reduces peripheral vision without other symptoms. If the IOP remains high, the optic nerve destruction can progress until all vision is lost. AqueSys claims its XEN Gel stent is the first glaucoma device to achieve similar IOP reduction as traditional sub-conjunctival trabeculectomy and tube shunt procedures through a minimally invasive technique with less associated surgical and post-operative risk.

“AqueSys has reinvented the approach to sub-conjunctival outflow. It’s the same space surgeons have trusted for close to 100 years, but we’ve never had a minimally invasive procedure to get access to it. This offers the advantage of a simpler and safer way of doing a well-recognized procedure, said Iqbal “Ike” Ahmed, M.D., assistant professor and research director at the Kensington Eye Institute at the University of Toronto. “The mechanism of action of the XEN allows for a target pressure in the low teens, which makes it suitable for a broad range of glaucoma stages. I’ve used it with and without cataract surgery with similar efficacy.”

More than 1,800 XEN Gel stents have been implanted to date, mostly in Europe, where the product has earned the CE Mark. In the United States, the stent is an investigational device and thus is limited by federal law to investigational use.

“AqueSys is pleased to introduce the XEN Gel Stent technology to Canadian ophthalmologists which will enable them to deliver gold standard efficacy to their patients through a minimally invasive, standardized procedure,” said Ron Bache, CEO of AqueSys.

Based in Aliso Viejo, Calif., AqueSys is a privately-held, venture capital-funded ophthalmic company that develops and commercializes implantable glaucoma treatment devices.