Article

Pivotal iStent Inject Data Led to Approval

■ Glaukos Corporation said the positive US Investigational Device Exemption (IDE) pivotal trial results for its next-generation iStent inject Trabecular Micro-Bypass System have been published in Ophthalmology. The results of the iStent inject prospective, randomized, controlled, multicenter clinical trial, which included 505 mild-to-moderate POAG subjects from 41 investigational sites, formed the basis for FDA approval of the device in June 2018. In the study, 387 subjects were randomized to iStent inject in combination with cataract surgery and 118 subjects were randomized to cataract surgery only. Subjects were followed through 24 months with annual medication washouts.

The iStent inject met the study’s primary and secondary effectiveness endpoints. At 24 months, 75.8% of the iStent inject cohort achieved a 20% or greater reduction in unmedicated diurnal IOP, compared to 61.9% for the cataract-only cohort. At 24 months, the mean reduction in unmedicated diurnal IOP was 7.0 mmHg for the iStent inject cohort and 5.4 mmHg for the cataract-only cohort. Through 24 months, the overall safety profile of iStent inject was highly favorable, with the rate of adverse events for iStent inject in combination with cataract surgery similar to cataract surgery alone.