|Courtesy of Glaukos|
When Glaukos got the FDA's blessing for iStent in June, it notched two first-evers: The device is the first microbypass technology designed to reduce pressure during cataract surgery and, at 1 mm in length, it's the tiniest implant the agency has ever approved.
The stent is a titanium tube inserted into the eye, allowing for the drainage of fluids to reduce in-eye pressure for glaucoma patients after cataract surgery. In patients with open-angle glaucoma, intraocular fluids can build up and create pressure that can damage the optic nerve. With iStent, the fluid is drained from the eye, possibly saving patients' vision.
In a study of 239 patients, the iStent significantly reduced pressure levels during surgery without medication.
But Glaukos may not be alone on the market for long. California devicemaker Ivantis closed a $27 million funding round last week to support FDA-targeted studies of the Hydrus Microstent, an eyelash-sized device that works similarly to relieve fluid-caused pressure. However, at least for now, Glaukos owns the market for microinvasive glaucoma surgery devices.