iSTAR Medical Receives FDA Approval to Begin Trial for MINIject for Patients With Glaucoma
iSTAR Medical announced that the FDA granted it investigational device exemption (IDE) to start a trial with MINIject. The STAR-V study will investigate MINIject in over 350 patients with primary open-angle glaucoma. Glaucoma surgeons in the United States, Canada, and Europe will join the trial.
The STAR-V trial evaluates MINIject’s efficacy by the mean reduction in eye pressure, as well as the proportion of patients achieving at least a 20% reduction in eye pressure. This study will report on safety and efficacy of MINIject alone, in a procedure not combined with simultaneous cataract surgery. Key study findings will become available when all patients have completed 2 years in the study. Patients will also be followed to evaluate long-term benefits and tolerability of MINIject in the treatment of mild to moderate glaucoma.
“On behalf of the investigators, I would like to share our excitement to start the STAR-V trial. The supraciliary space of the eye is a natural outflow pathway which has demonstrated great promise. There is the potential to deliver increased efficacy in lowering eye pressure for our patients in a less invasive fashion. Access to an effective pressure-lowering device that is used in a standalone procedure will enable us to offer treatment to many more glaucoma patients with a minimally-invasive treatment option,” Brian E. Flowers, MD, a glaucoma specialist at Ophthalmology Associates of Fort Worth, Texas, said in a company news release.
“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. Results from clinical trials in over 130 patients in Europe, Asia, and Latin America have consistently demonstrated that MINIject 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,” said Michel Vanbrabant, CEO of iSTAR Medical.