MAY 21, 2018
By Kanaga Rajan
The MINIject glaucoma device from iSTAR Medical is showing promising results in treating patients with mild to moderate primary open-angle glaucoma after 6 months of clinical trials.
Crafted from proprietary porous silicone, the micro-invasive glaucoma surgery (MIGS) device’s unique composition enables better bio-integration and fluid drainage than other drainage tubes, according to the press release. The device comes preloaded in an injector, and is implanted into the suprachoroidal space during a single-step procedure.
“These early results show a combination of exceptional efficacy, safety for patients, and device ease-of-use, which is very promising,” according to Ike Ahmed, MD, of the University of Toronto. Dr. Ahmed was one of the first surgeons to perform the MINIject procedures in the multi-center study.
The prospective analysis represents the first in-human trial for the MINIject. iSTAR enrolled 25 patients with mild to moderate open angle glaucoma that was uncontrolled by topical hypotensive medication. Six months after the procedure, participants had a 39% decrease in IOP to a mean of 14.2 mm Hg. Approximately 87.5% of patients were medication-free at 6 months. The MINIject also had an encouraging safety profile with no instances of implant migration.
The trial is ongoing, and investigators will continue to monitor the safety and performance of the device at 12 and 24 months.