WAVRE, Belgium — 16 May 2018: iSTAR Medical SA, a private medical device company developing novel ophthalmic implants for the treatment of glaucoma, today announced exceptional six-month results of their first-in-human (FIH) micro-invasive glaucoma surgery (MIGS) trial for the MINIjectTM device in a standalone setting. Results show MINIject to be safe and highly effective in achieving significant intraocular pressure (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 six months. In addition, 87.5% of patients were able to discontinue topical medication usage and remained medication-free at six months. There were no serious ocular adverse events.
The FIH trial is a prospective, open, international, multi-centre 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 six months. Subsequent safety and performance will be measured up to two 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.
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.
, said Prof. Philippe Denis, Croix-Rousse Hospital, Lyon, France, who was involved in the development of MINIject.
These early results show a combination of exceptional efficacy, safety for patients, and device ease-of-use, which is very promising.
, commented Dr Ike Ahmed, University of Toronto, Ontario, Canada, who performed some of the first MINIject procedures in the trial.
Glaucoma is the second leading cause of blindness globally according to the World Health Organisation, affecting over 80 million people. About 2.5 million people worldwide are blind due to glaucoma. MIGS is the most promising and fastest-growing therapeutic option in the treatment of glaucoma.
ClinicalTrials.gov identifier: NCT03193736
