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Cumulative results of Xen gel stent implantation in Europe promising for US
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FORT LAUDERDALE, Fla. — If approved by the FDA, Allergan’s Xen45 implant will be an additional tool to surgically manage glaucoma in the U.S., Davinder S. Grover, MD, MPH, said at the American Glaucoma Society meeting, where he reported on the international experience of the first 975 glaucomatous eyes treated with any one of three iterations of the gel stent.
At 12 months, “for all comers,” there is nearly a 33% reduction in IOP and a reduction of 1.7 glaucoma medications, Grover said. Efficacy was similar to that of traditional glaucoma surgery with fewer complications.
Davinder S. Grover
All comers included eyes implanted with devices with varying lumen sizes — 140 µm, 63 µm and 45 µm — with at least 12 months of follow-up. The prospective, nonrandomized, multicenter case series represents “a mixed bag of data,” Grover said, with the data including the entire compilation of multiple studies and commercial training cases that AqueSys (now Allergan) collected over a 3-year period. Data include results of eyes that were implanted with any one of four iterations of injector, with or without phacoemulsification, and without a washout period.
Results are consistent with an ongoing prospective phase 4 European study of 240 eyes, Grover said. The Xen45 has a CE mark as a standalone procedure or for use in conjunction with cataract surgery to reduce IOP.
“Possibly, [the Xen45] is the simplest and safest way to create a new drain in glaucoma patients,” Grover said. – by Patricia Nale, ELS
Disclosure: Grover reports he is a speaker for Allergan and Reichert Technologies and is a clinical investigator for AqueSys (now Allergan). The study was sponsored by Allergan, but no honoraria or payment was made for authorship.