Glaukos Corporation (NYSE:GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, today announced positive topline results from the Phase 4 prospective, randomized, controlled clinical trial (GLK-101-04) evaluating iDose® TR administered in conjunction with cataract surgery compared to cataract surgery alone in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

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. 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<0.0001). In addition, iDose TR demonstrated statistically significant superiority across all pre-specified secondary responder analyses, further supporting the consistency and robustness of the treatment effect observed in the study.

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

"We are pleased to announce these positive Phase 4 results, which add to the extensive body of clinical evidence supporting the efficacy, durability, and safety of iDose TR," said Thomas Burns, Glaukos chairman and chief executive officer. "Importantly, these data further reinforce the versatility of iDose TR across various administration settings, demonstrating its ability to deliver clinically meaningful robust IOP reduction whether administered as a standalone procedure or in conjunction with cataract surgery. iDose TR continues to deliver strong clinical outcomes that provide meaningful benefits for patients, helping to accelerate a broader treatment paradigm shift toward earlier, interventional glaucoma care."

GLK-101-04 is a Phase 4, prospective, multicenter, randomized, double-masked, parallel-group clinical trial evaluating the efficacy and safety of iDose TR in combination with cataract surgery compared to cataract surgery alone in adults with OAG or OHT. 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.

iDose TR is a first-of-its-kind, 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 three years. iDose TR is intended to improve the standard of care by addressing the ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications.