iStar Reports Positive Results for MINIject in First-in-Human Trial

Belgium-based iStar Medical reported Dec. 19 that its MINIject device produced positive one-year results in a first-in-human trial in glaucoma patients.

The STAR-I trial demonstrated that patients implanted with the MINIject in stand-alone surgery saw an average 32.6 percent IOP reduction to a mean of 15.6 mmHg at one year. In addition, 75 percent of patients were able to discontinue topical drops and remained medication-free at one year.

There were no serious ocular adverse events, and no patient required subsequent glaucoma surgery, iStar said.

The multicenter study enrolled 25 patients with mild to moderate primary open-angle glaucoma uncontrolled by topical medication.

The MINIject supraciliary device, a minimally invasive glaucoma surgery (MIGS) device, is made of a soft, flexible microporous material and is implanted with a very small part of the device remaining in the anterior chamber. Results showed minimal endothelial cell loss compared with baseline at one-year follow-up (mean change -2 percent), iStar said.

Endothelial cell loss has been of heightened concern since Alcon voluntarily withdrew its CyPass MIGS device in August 2018 due to concerns over endothelial cell loss at five years post-implantation. Study results suggested a relationship between the length of the CyPass device exposed in the anterior chamber and endothelial cell loss.