Glaukos Corporation announced positive top-line results from the phase 4, prospective, randomized, controlled clinical trial (GLK-101-04) evaluating iDose TR administered in conjunction with cataract surgery compared with cataract surgery alone in patients with open-angle glaucoma or ocular hypertension. iDose TR is a long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for up to 3 years. The study achieved its primary efficacy endpoint, with iDose TR demonstrating statistically significant superiority in the reduction of mean diurnal intraocular pressure (IOP) when administered in conjunction with cataract surgery compared to cataract surgery alone, the company said in a press release. 

The study randomized 149 study eyes, with 74 eyes assigned to the iDose TR in combination with cataract surgery arm and 75 eyes assigned to the cataract surgery alone arm. The primary endpoint evaluated the change from baseline in mean diurnal IOP at month 3. At month 3, subjects undergoing cataract surgery and administration of iDose TR achieved a mean diurnal IOP reduction of 11.1 mmHg from baseline, compared to 7.4 mmHg for subjects undergoing cataract surgery alone, demonstrating statistically significant superiority with a clinically meaningful incremental treatment effect of 3.6 mmHg (P<.0001). In addition, iDose TR demonstrated statistically significant superiority across all prespecified secondary responder analyses, further supporting the consistency and robustness of the treatment effect observed in the study, according to the company.

iDose TR also demonstrated a favorable safety profile through 3 months, with no treatment-related adverse events of corneal endothelial cell loss or cystoid macular edema, and no serious corneal adverse events. Overall safety findings were consistent with the well-established safety profile of iDose TR and previous clinical experience, the company reported. GP