FDA approves CyPass Micro-Stent, an implant for Glaucoma

The US Food and Drug Administration (FDA) has approved the CyPass Micro-Stent, a device for treatment of mild to moderate primary open-angle glaucoma that is intended to be implanted along with cataract surgery. It will be marketed by Alcon, a division of Novartis. This stent creates a channel for liquids to flow out from the anterior chamber of the eye, thereby reducing the intraocular pressure.

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The device is implanted in the supraciliary space between the sclera and the ciliary body. It is cylinder shaped with an entry port on one end and a series of holes throughout its body that diffuse the liquid flowing through. The shape and the holes give pressure, to make the liquid move through the device.

The clinical achievements of CyPass Micro-Stent system were evaluated by reading a study of 505 patients with POAG. 374 patients were randomized to the CyPass Micro-stent in combination with cataract surgery, and 131 patients were randomized to cataract surgery alone.

The study reviewed the percentage of patients with at least a 20% reduction in mean diurnal IOP from baseline and adverse events (AEs) for 24 months after implantation. 72.5% achieved a significant lowering of their IOP, compared to 58.0% of patients who had cataract surgery alone.

See here the FDA aprovement.


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