FDA News

Glaukos completes enrollment in iStent infinite trial

Glaukos has completed patient enrollment in an FDA investigational device exemption trial for the iStent infinite trabecular micro-bypass system.

The iStent infinite, designed to reduce elevated IOP in refractory glaucoma patients, consists of three heparin-coated titanium stents that are injected around Schlemm’s canal to restore the physiological outflow of the aqueous humor, according to a press release. It is inserted during a stand-alone procedure.

The prospective, unmasked, multicenter, single-arm clinical trial includes patients with previous unsuccessful incisional glaucoma surgery and IOP not controlled with currently tolerated topical ocular hypotensive medication and patients who did not receive surgery and are on maximally tolerated topical ocular hypotensive medication with uncontrolled IOP.

The primary effectiveness endpoint is a 20% or greater reduction in mean diurnal IOP from baseline at 12 months after surgery on the same or fewer medications, the release said.

Glaukos has completed patient enrollment in an FDA investigational device exemption trial for the iStent infinite trabecular micro-bypass system.

The iStent infinite, designed to reduce elevated IOP in refractory glaucoma patients, consists of three heparin-coated titanium stents that are injected around Schlemm’s canal to restore the physiological outflow of the aqueous humor, according to a press release. It is inserted during a stand-alone procedure.

The prospective, unmasked, multicenter, single-arm clinical trial includes patients with previous unsuccessful incisional glaucoma surgery and IOP not controlled with currently tolerated topical ocular hypotensive medication and patients who did not receive surgery and are on maximally tolerated topical ocular hypotensive medication with uncontrolled IOP.

The primary effectiveness endpoint is a 20% or greater reduction in mean diurnal IOP from baseline at 12 months after surgery on the same or fewer medications, the release said.