Glaukos Reports Positive Topline Outcomes For Both Phase 3 Pivotal Trials Of IDose TR

(RTTNews) - Ophthalmic medical technology and pharmaceutical company Glaukos Corp. (GKOS), on Wednesday, announced positive topline data for both Phase 3 pivotal trials of iDose TR that achieved its pre-specified primary efficacy endpoints through 3 months in both Phase 3 trials and "demonstrated excellent tolerability and a favorable safety profile through 12 months."

Thomas Burns, Glaukos chairman and chief executive officer, said, "We are very pleased to announce these robust and replicative positive Phase 3 pivotal data results for iDose TR, which mark a major milestone for our company and powerfully reaffirms our view that iDose TR can be a transformative novel technology able to fundamentally improve the glaucoma treatment paradigm for patients."

Based on the combined efficacy and safety results from both Phase 3 pivotal trials, Glaukos plans to move forward with its plans for an NDA submission to the U.S. FDA for the slow-release iDose TR model, with an expected FDA review and decision completed by the end of 2023.

The first of the two Phase 3 pivotal trials, referred to as GC-010, randomized a total of 590 subjects, comprised of 200 subjects in the slow-release iDose TR arm, 197 subjects in the fast-release iDose TR arm and 193 subjects in the timolol active comparator arm.

The second of the two Phase 3 pivotal trials, referred to as GC-012, randomized a total of 560 subjects, comprised of 183 subjects in the slow-release iDose TR arm, 185 subjects in the fast-release iDose TR arm and 193 subjects in the timolol active comparator arm. In total, the Phase 3 trials randomized a total of 1,150 subjects across 89 clinical sites.