Pivotal trial data for iStent inject Trabecular Micro-Bypass System meets primary endpoint in glaucoma patients undergoing cataract surgery.- Glaukos Corp.

Glaukos Corp announced that two-year U.S. Investigational Device Exemption (IDE) pivotal trial data showed that its iStent inject Trabecular Micro-Bypass System achieved a statistically significant reduction in unmedicated diurnal intraocular pressure (IOP) in patients undergoing cataract surgery. The iStent inject met the study�s primary and secondary effectiveness endpoints. At 24 months, 75.3% of the iStent inject cohort achieved a 20% or greater reduction in unmedicated IOP, compared to 61.9% for the cataract-only cohort. At 24 months, the mean unmedicated IOP reduction was 6.9 mmHg for the iStent inject cohort, compared to 5.4 mmHg for the cataract-only cohort. Through 24 months, the overall rate of adverse events for the iStent inject in combination with cataract surgery was similar to cataract surgery only.

Additional key findings include the fact that at 24 months, observed data show that the iStent inject cohort achieved a 31% mean reduction in unmedicated (post-washout) IOP to 17.1 mmHg from an unmedicated (post-washout) mean baseline IOP of 24.8 mmHg. Also at 24 months, observed data show that 62.6% of the iStent inject cohort achieved unmedicated mean IOP at or below 18 mmHg, compared to 49.2% for the cataract-only cohort. Finally at 23 months, observed data show that the iStent inject cohort achieved a 75% reduction in the mean number of medications, compared to 47% for the cataract-only cohort. Results of the iStent inject prospective, randomized, multicenter clinical trial, which included 41 investigational sites and 505 open-angle glaucoma subjects, were presented at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.