■ Glaukos Corporation announced that 12-month US Investigational Device Exemption (IDE) pivotal trial data showed that its iStent infinite Trabecular Micro-Bypass System achieved a substantial reduction in mean diurnal IOP in patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy. The prospective, unmasked, multicenter, single-arm clinical trial enrolled subjects who had undergone prior unsuccessful incisional or cilioablative glaucoma surgery and had IOP not adequately controlled with IOP-lowering medications, as well as subjects who had not undergone prior incisional or cilioablative glaucoma surgery but were on maximally tolerated IOP-lowering medications with uncontrolled IOP.

In the trial, 72 subjects were implanted with the iStent infinite at 15 separate clinical sites. All surgeons performing the procedures were board-certified glaucoma specialists. Patients entered the iStent infinite IDE pivotal study with a mean baseline IOP of 23.4 mmHg on an average of 3.1 medications and an average of 2 failed prior surgeries. At 12 months, 76% of subjects achieved 20% or greater reduction in mean diurnal IOP from baseline on the same or a lower ocular hypotensive medication burden. Further, more than 50% of subjects achieved month 12 IOP reduction ≥30%. Subjects also achieved a 13% mean reduction in medication burden at 12 months. The safety profile in the study was highly favorable, with no explants, infections, or device-related interventions or hypotony reported through 12 months.