|The FDA has approved Glaukos' 1mm-long in-eye stent--courtesy of Glaukos|
California's Glaukos snagged FDA approval for its iStent device, a micro-bypass tech designed to relieve in-eye pressure after cataract surgery, the first of its kind.
The stent is a tiny titanium tube--about 1mm long--inserted into the eye, allowing for the drainage of fluids to reduce in-eye pressure for glaucoma patients after cataract surgery, the company said. Intraocular fluid can build up in the eyes of patients with open-angle glaucoma, according to the FDA, and the resultant pressure can lead to optic nerve damage and vision loss. By draining that fluid, Glaukos' device could help save the vision of glaucoma sufferers with cataracts, regulators said.
The agency examined effectiveness data on 239 participants, finding that, a year after surgery, 68% of the patients using iStent had target or better pressure levels without the use of medication, compared to 50% of those without the device. The FDA also examined safety data for a total of 289 patients, with positive results.
The company is planning to develop a full portfolio of micro-bypass stents, all targeting glaucoma. Glaukos has been at work on the device for years, and it was named one of The Wall Street Journal's Top 50 Venture Backed Companies in 2011.
- read the FDA's release