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FDA allows Glaukos to begin IDE trial for iStent SA

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The FDA will allow Glaukos to move forward with a U.S. investigational device exemption clinical trial for the iStent SA, the company announced in a press release.

The iStent SA trabecular micro-bypass system is indicated as a standalone procedure to reduce IOP in pseudophakic patients who have previously undergone cataract surgery and who have mild to moderate primary open-angle, pigmentary or pseudoexfoliative glaucoma, according to the release.

The primary endpoint of the multicenter pivotal trial will be noninferiority to selective laser trabeculoplasty at 1 year. The randomized trial will enroll approximately 400 subjects plus about 80 additional subjects from the trial phase.

The iStent SA system uses the same method of action as the iStent and is about one-third the size of the iStent, according to the release.

“Our commencement of the iStent SA trial brings us a step closer to making an approved MIGS option available to address an unmet clinical need and to treat a wider cohort of glaucoma patients,” company president and CEO Thomas Burns said in the release.