MINIject approved in Europe for open-angle glaucoma
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The MINIject MIGS device has been approved in Europe for patients with open-angle glaucoma, according to a press release from iSTAR Medical.
In four trials in more than 150 patients, the device has demonstrated sustained IOP reduction and 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 in the release.
The device is being rolled out in select regions across Europe, and the first commercial implantations have been performed in Germany.
In the United States, MINIject is under evaluation in the pivotal STAR-V study, which will enroll more than 350 patients with primary open-angle glaucoma.