Glaukos Corp. (GKOS) has submitted a supplemental pre-market approval application to the FDA for the iStent infinite Trabecular Micro-Bypass System. The iStent infinite is an investigational device designed for use in a standalone procedure to reduce elevated intraocular pressure in patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy.
"This filing marks a significant achievement for Glaukos as we continue to advance our deep pipeline of glaucoma surgical devices and sustained pharmaceuticals," said Thomas Burns, CEO.
Glaukos launched the iStent, the company's first Micro-Invasive Glaucoma Surgery device, in the United States in July 2012, next-generation iStent inject device in September 2018, and most recently, the iStent inject W device in October 2020.
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