The iStent made by Glaukos Corp., a California medical device firm, is a titanium tube that can help drain excess fluid that builds up pressure inside the eye. Intraocular pressure has the potential to damage the optic nerve.
Patients with mild or moderate open-angle glaucoma, and who have a cataract in one or both eyes, typically use medications to control the amount of pressure building up. Open-angle glaucoma is the loss of peripheral vision and is the most common form of glaucoma.
In clinical trials, the iStent proved to be more effective in reducing pressure without any use of pressure-lowering drugs compared to those who underwent cataract surgery alone.
In the announcement, the FDA noted that the iStent offers an early intervention for patients compared with other surgical procedures.
“The iStent is a new option that may be considered in the treatment of open-angle glaucoma in patients needing cataract extraction,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health, in a news release. “This option may be considered earlier in the disease process than some other types of surgical glaucoma treatments.”
A call to Jeff Wells, Glaukos Corp.’s senior vice president of regulatory and quality affairs, was not returned.
The company has raised more than $90 million since 2002, according to regulatory filings.