iSTAR Medical announced 6-month results of their first-in-human microinvasive 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 first-in-human 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. The investigators and performing surgeons include Dr. Ike Ahmed (Toronto, Canada), Dr. Ernesto Calvo (Panama City, Panama), Prof. Philippe Denis (Lyon, France), Prof. Christoph Hirneiss (Munich, Germany) and Dr. Anita Kamarthy (Hyderabad, India). Adverse events were assessed by an independent Safety Monitoring Committee (SMC).
iSTAR Medical’s MINIject device provides a safe, effective and sustainable solution to significantly reduce IOP by enhancing aqueous humour outflow from the anterior chamber to the supraciliary space. 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 micro-porous, multi-channel geometry. The proprietary STAR material has anti- fibrotic properties, which minimise scarring and maintain implant performance over time.
Prof. Philippe Denis, Croix-Rousse Hospital, Lyon, France, was involved in the development of MINIject. He said: “We are very pleased with the safety results for this supraciliary procedure. There were no implant migrations. MINIject has been well-designed and the low number of adverse events is encouraging.”
Dr. Ahmed, University of Toronto, Ontario, Canada, performed some of the first MINIject procedures in the trial. He commented: “These early results show a combination of exceptional efficacy, safety for patients, and device ease-of- use, which is very promising.”