The approval covers the use of the system to decrease intraocular pressure (IOP) in adults with mild-to-moderate primary open-angle glaucoma (POAG) and undergoing concomitant cataract surgery.
iStent inject creates two bypasses in the trabecular meshwork to enable multi-directional flow through Schlemm’s canal for optimising the natural aqueous humor outflow.
The next-generation trabecular micro-bypass device features two heparin-coated titanium stents that are preloaded into an auto-injection system.
This capability is said to facilitate precise implantation of stents into two trabecular meshwork locations via only one corneal entry point with a click-and-release motion.
Glaukos president and CEO Thomas Burn said: “The approval of iStent inject represents another major Glaukos milestone in the pursuit of our mission to transform glaucoma therapy and further strengthens our position at the forefront of micro-scale innovation.
“Given its clinical performance and enhanced procedural elegance, we believe the iStent inject will be an attractive, two-stent solution for US ophthalmic surgeons to reliably manage glaucoma patients’ IOP in a straightforward and effective manner.”
The FDA decision comes after a review of results from a randomised, multi-centre clinical trial conducted in 505 patients with mild to moderate POAG at 41 clinical sites.
Findings indicated a statistically significant decrease in unmedicated diurnal IOP in subjects undergoing cataract surgery, with the iStent inject at 24 months.
Glaukos is planning to begin preparations for the initial commercial launch of the micro-bypass system in the third quarter of this year.
Currently, the device is commercially available in the European Union, Australia, Canada, Brazil, Armenia, Singapore, Hong Kong and South Africa.