FDA grants Investigational Device Exemption for MINIject in glaucoma patients

The MINIject implant is made of proprietary STAR material. (Image courtesy of iSTAR Medical)

The FDA this week granted an Investigational Device Exemption to iSTAR Medical to kick off a pivotal trial of the company’s MINIject.

The STAR-V study will investigate MINIject in over 350 patients with primary open angle glaucoma. Glaucoma surgeons in the United States, Canada and Europe will join the trial, according to the company, which develops minimally-invasive implants for glaucoma surgery (MIGS).

According to the company, the STAR-V trial will evaluate MINIject's efficacy by the mean reduction in eye pressure, as well as the proportion of patients achieving at least a 20 percent reduction in eye pressure.

This study will report on safety and efficacy of MINIject alone, in a procedure not combined with simultaneous cataract surgery. Key study findings will become available when all patients have completed 2 years in the study. Patients will also be followed to evaluate long-term benefits and tolerability of MINIject in the treatment of mild to moderate glaucoma.

Brian E. Flowers, MD, a glaucoma specialist at Ophthalmology Associates of Fort Worth, Texas, said the team of investigators is looking forward to the trial

“The supraciliary space of the eye is a natural outflow pathway which has demonstrated great promise,” he said in a statement. “There is the potential to deliver increased efficacy in lowering eye pressure for our patients in a less invasive fashion. Access to an effective pressure lowering device that is used in a standalone procedure will enable us to offer treatment to many more glaucoma patients with a minimally-invasive treatment option."

Michel Vanbrabant, CEO of iSTAR Medical, said the company is looking forward to the start of the STAR-V trial.

“We are very pleased that the FDA has granted us approval to bring this innovative technology to North American patients suffering from primary open angle glaucoma in the STAR-V trial,” he said in a statement. “Results from clinical trials in over 130 patients in Europe, Asia and Latin America have consistently demonstrated that MINIject maintains a positive safety profile, and delivers a significant reduction of pressure thanks to our proprietary STAR material and the power of the supraciliary space.”