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Enrollment complete for Glaukos iStent inject pivotal trial
Enrollment in an investigational device exemption trial for the iStent inject is complete, according to a Glaukos press release.
The prospective multicenter trial includes 500 patients with glaucoma and cataracts randomized to receive both iStent inject and cataract surgery or to undergo cataract surgery alone. The trial is slated to last 2 years with a primary endpoint of 20% or greater IOP reduction from baseline.
The company anticipates using the pivotal trial results to form the basis of its premarket approval submission to the FDA.
The iStent inject is approved for commercial use in the European Union and Australia, where it received regulatory approval from the Australian Therapeutic Goods Administration for use in conjunction with cataract surgery to reduce IOP in patients with mild-to-moderate glaucoma who are being treated with medication, the company announced in a separate news release.