MedTech

iSTAR gains European approval for implant for glaucoma surgery

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While glaucoma is the leading cause of irreversible blindness affecting around 100 million people worldwide, iSTAR Medical, a Belgium-based medtech company pioneering novel minimally-invasive implants for glaucoma surgery (MIGS), announced Wednesday, that its breakthrough MIGS device, MINIject™, has been approved in Europe for open-angle glaucoma patients.

As such, MINIject enables more patients to be effectively treated with MIGS because of its powerful and sustained performance combined with an excellent safety profile.

In addition, it represents the most promising and fastest-growing glaucoma therapy, due to its enhanced safety profile compared to traditional surgery. Studies by iSTAR Medical across four trials in over 150 patients, show that MINIject demonstrates a balance of powerful and sustained intra-ocular pressure (IOP) reduction with a positive safety profile.

“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.

“This is a major milestone for iSTAR Medical and our mission to bring truly next-generation MIGS devices to the glaucoma community,” he noted. “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,” the CEO added.

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.

 Moreover, MINIject is 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 U.S. market.

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