Glaukos Corp. reported 12-month results from the pivotal IDE trial of its Istent Infinite trabecular micro-bypass system, showing substantial reduction in mean diurnal intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medication. The company is targeting U.S. FDA approval of the device for standalone moderate-to-severe glaucoma in late 2021.
San Clemente, Calif.-based Glaukos Corp. has finished enrolling patients in its U.S. investigational device exemption (IDE) trial for the Istent Infinite trabecular micro-bypass system, which is intended for standalone use in lowering intraocular pressure (IOP) in refractory glaucoma patients. If all goes as planned, the company is looking to commercially launch the treatment in the U.S. in 2021.