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
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