MINIject consistently displays a balance of robust and prolonged IOP reduction with a favorable safety profile, according to data presented to date by iSTAR Medical across four trials involving over 150 patients.
MINIject's high efficacy and safety make it ideal for treating a wider range of glaucoma patients, allowing it to be used in a greater range of operations.
MINIject is now available commercially in select regions across Europe, and iSTAR Medical is pleased to announce that the first commercial implantations have already taken place in Germany.
"With today’s European approval, MINIject becomes the only commercially available MIGS device targeting the supraciliary space as a natural outflow pathway for IOP reduction," Michel Vanbrabant, CEO of iSTAR Medical, said in a company news release.
"This is a major milestone for iSTAR Medical and our mission to bring truly next-generation MIGS devices to the glaucoma community. I want to thank our team, our investors, and our medical partners for their continued belief in a safer and better way to manage glaucoma by targeting the supraciliary space, with an implant powered by our proprietary STAR material."
Positive two-year results from iSTAR Medical’s STAR-II European trial were recently presented at the 125th American Academy of Ophthalmology (AAO) meeting in New Orleans, demonstrating a sustained powerful efficacy and safety outcome in patients with open-angle glaucoma, consistent with all MINIject trial outcomes to date.
After receiving the European approval, Professor Dr. Burkhard Dick, Head of the Department of Ophthalmology at University Eye Hospital Bochum in Germany, and one of the MINIject STAR-II trial investigators, treated the first patient using MINIject.
He commented: "I’m very pleased that I’m now able to offer the MINIject supraciliary device as a treatment option to my mild-to-moderate glaucoma patients, the first of which was treated successfully today. Based on results so far, MINIject may open up new treatment paradigms for patients with glaucoma across Europe."
MINIject is now being studied in iSTAR Medical's key STAR-V research, which was approved by the FDA in July 2021 and the results of findings will be critical in gaining commercial access for MINIject in the United States. The study will enroll over 350 patients with primary open-angle glaucoma.