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
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