The pivotal trial of MINIject, STAR-V, now initiated in 13 sites across the US, has received positive feedback from glaucoma surgeons involved in the trial.
iSTAR Medical announced initial positive progress of MINIject in its US STAR-V trial.
According to the company, MINIject is a minimally-invasive glaucoma surgery (MIGS) implant and the only commercially available supraciliary MIGS device. The trial is now initiated in 13 sites across the U.S.. with positive feedback on initial implantations from world-leading glaucoma surgeons.
The company also noted that MINIject has demonstrated meaningful and enduring IOP reduction, combined with a favorable safety profile, in completed and ongoing trials conducted in Europe, the Americas and Asia in more than 150 patients so far.
The STAR-V trial is a US FDA-approved pivotal study assessing the safety and efficacy of MINIject in over 350 patients with primary open-angle glaucoma across the US, Canada and Europe. Following the trial’s FDA IDE approval in 2021, patient enrollment has been progressing as planned.
On the heels of the approval in MINIject in Europe, Michel Vanbrabant, CEO of iSTAR Medical noted that the company is pleased with the progress of its U.S. trial.
“We remain very encouraged by the strong feedback from clinicians so far, and we are confident that our STAR-V trial will build on the safety and efficacy outcomes demonstrated by MINIject in the STAR-I to STAR-IV trials,” he said.
According to Steven D. Vold, MD, a glaucoma specialist from Vold Vision in Fayetteville, Arkansas, and a STAR-V trial investigator, there is significant untapped potential in targeting the supraciliary space when leveraging MIGS to treat glaucoma, and MINIject enables this to be captured.
“iSTAR Medical’s approach uses its unique silicone micropore tissue friendly STAR material that enables biointegration,” he said in a statement. “The supraciliary space has previously been demonstrated to be one of the most efficacious targets, and I am excited at the prospect of having a new MIGS approach with such strong potential to offer my patients.”
Brian E. Flowers, MD, a glaucoma specialist at Ophthalmology Associates in Forth Worth, Texas, and an investigator in STAR-V, pointed out that MINIject’s highly biocompatible anti-fibrotic technology enables safe and meaningful IOP reduction for patients, without compromising corneal health.
“Additionally, it doesn’t require a bleb, reducing post-implantation patient management and potential complications,” Flowers said in a statement. “Overall, based on my implantations to date, I am encouraged by MINIject’s potential to be a game-changing MIGS device in the stand alone setting to improve disease management and quality of life in glaucoma patients.”
According to William J. Flynn, MD, from Eye Associates Research in San Antonio, Texas, the potential efficacy and safety means that MINIject may open the door to treating a much larger patient population who previously could not be treated by other MIGS devices.
“ I am excited to be part of this trial and based on my positive experience thus far, I am optimistic for MINIject to be a valuable addition to our glaucoma treatment armamentarium,” he concluded.