The U.S. Food and Drug Administration (FDA) has granted iSTAR Investigational Device Exemption (IDE) approval for to begin a trial with MINIject, a revolutionary MIGS device for patients with primary open-angle glaucoma. The study will test the safety and efficacy of MINIject’s ability to reduce pressure in the eye, including how many patients reduce at least 20% of their eye pressure, without simultaneous cataract surgery. The study will include over 350 patients with primary angle glaucoma, and monitor and evaluate the long-term benefits of MINIject. “We are very pleased that the FDA has granted us approval to bring this innovative technology to North American patients suffering from primary open angle glaucoma in the STAR-V trial,” stated CEO of iSTAR Medical, Michel Vanbrabant, “Results from clinical trials in over 130 patients in Europe, Asia and Latin America have consistently demonstrated that MINIjectTM maintains a positive safety profile, and delivers a significant reduction of pressure thanks to our proprietary STAR material and the power of the supraciliary space.”
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