Key Takeaways

  • The Phase 4 GLK-101-04 trial met its primary endpoint, demonstrating statistically significant superiority in IOP reduction with iDose TR plus cataract surgery compared with cataract surgery alone

  • Mean diurnal IOP decreased by 11.1 mmHg in the combination group versus 7.4 mmHg with cataract surgery alone at month 3 (P<.0001)

  • No treatment-related corneal endothelial cell loss or cystoid macular edema adverse events were reported through 3 months, supporting a favorable short-term safety profile

Glaukos announced positive topline results from its phase 4 GLK-101-04 clinical trial evaluating iDose TR administered in conjunction with cataract surgery in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

The study met its primary efficacy endpoint, demonstrating statistically significant superiority in mean diurnal IOP reduction at 3 months compared with cataract surgery alone.

Patients receiving iDose TR with cataract surgery achieved a mean diurnal IOP reduction of 11.1 mmHg from baseline, compared with 7.4 mmHg in patients undergoing cataract surgery alone. The incremental treatment effect was 3.6 mmHg (P<.0001).

Glaukos also reported statistically significant superiority across all prespecified secondary responder analyses.

The prospective, multicenter, randomized, double-masked, parallel-group trial included 149 study eyes, with 74 assigned to iDose TR plus cataract surgery and 75 assigned to cataract surgery alone. The primary endpoint assessed change from baseline in mean diurnal IOP at month 3.

According to Glaukos, iDose TR demonstrated a favorable safety profile through 3 months. No treatment-related adverse events involving corneal endothelial cell loss or cystoid macular edema were reported, and no serious corneal adverse events occurred.

“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,” Thomas Burns, chairman and CEO of Glaukos, said in a company statement.

iDose TR is a long-duration intracameral implant designed to continuously deliver a proprietary formulation of travoprost for up to 3 years. The therapy is intended to reduce reliance on daily topical glaucoma medications and address challenges associated with treatment adherence.