Laguna Hills, Calif.-based Glaukos said the approval covers use of the iStent in conjunction with cataract surgery, making it the 1st within-the-eye micro-invasive glaucoma surgery device to hit the market in Japan.
The device is designed to be inserted via a small corneal incision into the Schlemm’s canal to restore the eye’s ability to drain aqueous fluid and relieve intraocular pressure. Glaukos won pre-market approval from the FDA for the iStent in 2012.
“The iStent represents an important new option for effectively managing elevated IOP in glaucoma, a disease that is a leading cause of blindness worldwide,” president & CEO Thomas Burns said in prepared remarks. “We appreciate the efforts of the MHLW to evaluate and approve the iStent and we are eager to introduce this breakthrough MIGS technology to Japanese surgeons and patients. This achievement also marks an important milestone for Glaukos as we expand our presence in the Asia Pacific region.”
Glaukos said it’s already established a direct sales force and a subsidiary in Japan and expects to launch the device there later this year, once the device wins reimbursement approval.