iSTAR Medical, a med-tech company developing minimally-invasive implants for glaucoma surgery (MIGS), announced today that the U.S. Food and Drug Administration (FDA) granted it Investigational Device Exemption (IDE) to start a pivotal trial with MINIjectTM. 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 percent 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 MINIjectTM in the treatment of mild to moderate glaucoma.
Dr. Brian E. Flowers, a glaucoma specialist at Ophthalmology Associates of Fort Worth, TX, USA said.
MINIject is iSTAR Medical’s revolutionary MIGS device for patients with primary open-angle glaucoma. MINIject combines the unique porous structure of its proprietary STAR material with the power offered by the supraciliary space. As a result, it is designed to enhance natural fluid outflow, reducing intraocular pressure (IOP) and the need for medication, while bio-integrating with surrounding tissue, limiting inflammation, fibrosis and subsequent complications.