iSTAR Medical SA, a private medical device company developing novel ophthalmic implants for the treatment of glaucoma, today announced exceptional one-year results of the first-in-human, micro-invasive glaucoma surgery (MIGS) STAR-I trial, for the MINIject™ device in a standalone setting. Results demonstrate that MINIject is safe and highly effective in achieving significant intraocular pressure (IOP) reduction, as well as easing medication burden in glaucoma patients.
The trial demonstrated that the implantation of MINIject resulted in an average 32.6% IOP reduction to a mean of 15.6mmHg at one year. In addition, 75% of patients were able to discontinue topical medication usage and remained medication-free at one year. There were no serious ocular adverse events and no patient required subsequent glaucoma surgery.
The STAR-I trial is a prospective, open, international, multi-centre study in which MINIject was implanted in 25 patients with mild-to-moderate, primary open angle glaucoma uncontrolled by topical hypotensive medication. The aim is to assess the safety and performance of the MINIject device measured by IOP reduction under medication from baseline to six months, with follow-up to two years post-surgery.