Glaukos Submits US IDE for Clinical Study of iStent Infinite in Refractory Glaucoma

January 5, 2018: By Jon Swedien

Glaukos submitted an investigational device exemption (IDE) application to the US FDA to study its iStent Infinite Trabecular Micro-Bypass System for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in refractory glaucoma patients, the San Clemente, California, company announced Jan. 3.

The iStent Infinite is made up of three heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents around Schlemm’s canal across a span of five to six hours. Once in place, the stents are designed to lower IOP by restoring the natural outflow of aqueous humor, Glaukos said.

In the IDE application, Glaukos proposes to conduct a prospective, multi-center, single-arm clinical trial to evaluate safety and performance of the iStent Infinite in about 65 refractory subjects or subjects on maximally tolerated ocular hypotensive medications. The proposed primary endpoint is a 20 percent or greater reduction in IOP from baseline at 12 months on the same or fewer medications, Glaukos said. The company said it plans to use the trial results as the basis for seeking FDA clearance via a 510(k) submission.

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