iSTAR Medical, a medtech company developing novel minimally-invasive implants for glaucoma surgery (MIGS), has seen its MIGS device, MINIject approved in Europe for open-angle glaucoma patients.
Glaucoma is the leading cause of irreversible blindness affecting around 100 million people worldwide. MIGS represents the most promising and fastest-growing glaucoma therapy, due to its enhanced safety profile compared to traditional surgery. Data reported to date by iSTAR Medical across four trials in over 150 patients, consistently show that MINIject demonstrates a balance of powerful and sustained intra-ocular pressure (IOP) reduction with a positive safety profile.
iSTAR Medical is now rolling out MINIject commercially in select regions across Europe and is delighted that its first commercial implantations have already taken place in Germany.
Michel Vanbrabant, CEO of iSTAR Medical, said: “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. 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.”
Professor Dr. Burkhard Dick, head of the Department of Ophthalmology at University Eye Hospital Bochum, Germany, and one of the MINIject STAR-II trial investigators, treated the first patient with MINIject after European approval.
He said: “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.”
Furthermore, MINIject is currently being investigated in iSTAR Medical’s pivotal STAR-V study, which was approved by the United States Food and Drug Administration (FDA) in July 2021, the results of which will be instrumental to gain commercial access for MINIject in the US market. The study will enrol over 350 patients with primary open-angle glaucoma.
