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Glaukos submits IDE application for iStent infinite three-stent system

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Glaukos Corporation has submitted an investigational device exemption application to the FDA to study the iStent infinite trabecular micro-bypass system, a three-stent device designed to reduce IOP in cases of refractory glaucoma in a standalone procedure, according to a company press release.

The company proposed to conduct a “prospective, multicenter, single-arm clinical trial to evaluate safety and performance of the iStent infinite in approximately 65 refractory subjects and/or subjects on maximally tolerated topical ocular hypotensive medications. The primary endpoint is proposed to be a 20% or greater reduction in IOP from baseline at 12 months on the same or fewer medications,” the release said.

According to the release, the heparin-coated titanium stents are preloaded into an autoinjector that allows the stents to be injected across a span of five to six clock hours around Schlemm’s canal.