Bags US FDA approval
iSTAR Medical, a med-tech company developing minimally-invasive implants for glaucoma surgery (MIGS), announced that the US Food and Drug Administration (FDA) granted it Investigational Device Exemption (IDE) to start a pivotal trial with MINIject. The STAR-V study will investigate MINIjectTM in over 350 patients with primary open-angle glaucoma. World-leading glaucoma surgeons in the US, 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 per cent reduction in eye pressure. This study will report on the 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 the long-term benefits and tolerability of MINIject in the treatment of mild to moderate glaucoma.
Dr Brian E Flowers, a glaucoma specialist at Ophthalmology Associates of Fort Worth, TX, US said, “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 that 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.”
Michel Vanbrabant, CEO, iSTAR Medical, commented “We are 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 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.”
