Glaukos wins FDA nod for IDE trial of iStent SA

Glaukos (NYSE:GKOS) said today it won FDA investigational device exemption to launch a pivotal study of its iStent SA trabecular micro-bypass system designed to treat glaucoma. The San Clemente, Calif.-based company’s iStent SA is designed to reduce intraocular pressure in psuedophakic, mild-to-moderate open-angle, pigmentary or psuedoexfoliative glaucoma patients, the company said. The system includes 2 micro-scale titanium stents in an auto-injection system which can be injected into trabecular meshwork locations through a single corneal entry point to restore physiological outflow of aqueous humor into the Sclemm’s canal. “We are delighted that our successful collaboration with the FDA allows Glaukos to begin the pivotal phase of this first-ever standalone Micro-Invasive Glaucoma Surgery, or MIGS, trial. We pioneered MIGS to overcome the challenges of conventional glaucoma therapies. Our commencement of the iStent SA trial brings us a step closer to making an approved MIGS option available to address an unmet clinical need and to treat a wider cohort of glaucoma patients,” prez & CEO Thomas Burns said in a press release. Glaukos’ multi-center, pivotal randomized trail aims to enroll 400 patients to evaluate the iStent SA compared to selective laser trabeculoplasty procedures. A total of 80 patients from the initial trial phase will be included in the pivotal trial, the company said. The primary efficacy endpoint of the trial is set to b...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance Glaukos Source Type: news