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FDA clears Xen for refractory glaucoma
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The FDA has cleared Allergan’s Xen glaucoma treatment system for refractory glaucoma, according to a company press release.
The Xen system consists of the Xen45 gel stent and the Xen injector. The stent is implanted through an ab interno approach and creates a new drainage channel to reduce IOP.
“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,” Robert N. Weinreb, MD, chairman and distinguished professor of ophthalmology at the University of California, San Diego, said in the release.
Allergan plans to launch the system in the U.S. in early 2017. It is already CE marked in the European Union, and more than 10,500 stents have been distributed around the world.