■ iSTAR Medical SA, a medical device company developing novel ophthalmic implants for the treatment of glaucoma, has announced encouraging 6-month results of their first-in-human micro-invasive glaucoma surgery (MIGS) trial for the MINIject device in a standalone setting. Results show MINIject to be safe and highly effective in achieving significant IOP reduction in glaucoma patients. The trial showed that the implantation of MINIject resulted in an average 39% IOP reduction to a mean of 14.2 mmHg at 6 months. In addition, 87.5% of patients were able to discontinue topical medication usage and remained medication-free at 6 months. There were no serious ocular adverse events.
The trial is a prospective, open, international, multicenter study in which a MINIject was implanted in 25 patients with mild-to-moderate, primary open angle glaucoma uncontrolled by topical hypotensive medication. The aim of the study is to assess the safety and performance of the MINIject device measured by IOP reduction under medication from baseline to 6 months. Subsequent safety and performance will be measured up to 2 years post surgery.
iSTAR says the MINIject device provides a safe, effective and sustainable solution to significantly reduce IOP by enhancing aqueous humor outflow from the anterior chamber to the supraciliary space. The company says the MINIject takes a new approach to drainage, which represents a paradigm shift. Unlike other technologies, MINIject uses STAR material, a soft and flexible medical-grade silicone with a microporous, multichannel geometry. The proprietary STAR material has antifibrotic properties, which minimize scarring and maintain implant performance over time, according to the company.