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FDA approves Glaukos iStent to reduce IOP in conjunction with cataract surgery
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The U.S. Food and Drug Administration has approved the iStent Trabecular Micro-Bypass stent system from Glaukos for use with cataract surgery to reduce IOP in adults with mild to moderate open-angle glaucoma currently being treated with ocular hypotensive medication.
The 1-mm device is designed to be placed ab interno into Schlemm’s canal using an inserter and intraoperative gonioscopy, according to a press release from Glaukos.
Use of the iStent could significantly alter glaucoma treatment, Thomas W. Samuelson, MD, OSN Glaucoma Section Editor, told Ocular Surgery News.
“This approval has the potential to dramatically change the way we treat glaucoma,” he said. “Glaukos has broken new ground in completing the first ever PMA/IDE randomized trial for an implantable glaucoma device. The ab interno canal-stenting era has begun.”
The pivotal investigational device exemption trial involved 239 participants with mild to moderate open-angle glaucoma and clinically significant cataract at 27 sites, the release said. Half of the study participants received cataract surgery and iStent implantation, while the other half received cataract surgery alone.
At 12 months postop, 68% of patients in the iStent group met the primary endpoint of IOP that was 21 mm Hg or less with no medications, compared with 50% in the group receiving cataract surgery alone, according to the release.
Disclosure:
- Dr. Samuelson is a consultant and investigator for Glaukos.