Glaukos Corporation (GKOS) has announced positive clinical updates for its iDose sustained-release procedural pharmaceutical platform, including promising data from a 36-month follow-up analysis of its Phase 3 pivotal clinical trials evaluating iDose TR. The data underscore iDose TR's potential to redefine glaucoma treatment by providing sustained intraocular pressure (IOP) reduction.
iDose TR Clinical Trial Results
The 36-month follow-up analysis of two Phase 3 pivotal trials showed that approximately 70% of patients treated with iDose TR remained well-controlled on the same or fewer IOP-lowering topical medications compared to 58% of those in the timolol control group. This demonstrates the long-term efficacy of a single administration of iDose TR in sustaining IOP reduction.
iDose TR also demonstrated excellent tolerability and a favorable safety profile throughout the 36-month study period. These results suggest that iDose TR could address the limitations of traditional glaucoma treatments, which often suffer from patient non-adherence and side effects.
iDose TR in Combination with Cataract Surgery
In a separate Phase 4 single-arm clinical study involving 60 open-angle glaucoma patients, iDose TR was implanted during cataract surgery. The combination achieved a mean IOP reduction of 11.3 mmHg (44%) at six months post-operation compared to baseline levels. This highlights the potential synergy between glaucoma management and cataract surgery, expanding the implant’s applications in ophthalmic care.
iDose TREX Development
Building on the success of iDose TR, Glaukos has initiated Phase 2b/3 clinical trials for iDose TREX, the next-generation sustained-release platform. iDose TREX is designed to be very similar in size and form factor to the original iDose TR but has nearly twice the drug capacity. Early-stage clinical updates suggest that iDose TREX could further reduce treatment frequency and enhance patient outcomes.
According to Thomas Burns, Glaukos chairman and chief executive officer, there is an important unmet clinical need and strong appetite within the ophthalmic community for safe, effective, and sustained procedural pharmaceutical alternatives to traditional topical medications. Glaukos aims to position iDose as a transformative novel platform technology able to fundamentally improve the treatment paradigm for patients with glaucoma or ocular hypertension.
