■ iStar Medical announced 1-year results of the first-in-human, microinvasive glaucoma surgery (MIGS) STAR-I trial, for the Miniject device in a standalone setting. Results announced by the company demonstrate that Miniject is safe and highly effective in achieving significant 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 1 year. In addition, 75% of patients were able to discontinue topical medication usage and remained medication-free at 1 year. There were no serious ocular adverse events and no patient required subsequent glaucoma surgery.
The STAR-I trial is a prospective, open, international, multicenter 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 6 months, with follow-up to 2 years after surgery.