iSTAR Medical receives US FDA approval to start pivotal trial for MINIject in glaucoma patients
World-leading surgeons to join iSTAR Medical’s STAR-V study
Wavre, Belgium: 15 July 2021 – 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.
More info on iSTAR Medical‘s website.