Glaukos Announces Positive Clinical Updates for its iDose® Sustained-Release Procedural Pharmaceutical Platform

These include:

• In a new 36-month follow-up analysis of its two Phase 3 pivotal clinical trials, iDose TR (travoprost intracameral implant) 75 mcg, an FDA-approved prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma, demonstrated sustained substantial IOP reductions as approximately 70% of iDose TR subjects remained well-controlled on the same or fewer IOP-lowering topical medications at 36 months after a single administration of iDose TR, versus 58% of timolol control subjects. In addition, iDose TR continued to demonstrate excellent tolerability and a favorable safety profile through 36 months across both Phase 3 trials.
• Glaukos has commenced a Phase 2b/3 clinical program for iDose TREX, its next-generation iDose sustained-release procedural pharmaceutical platform therapy. 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.
• In a new 6-month follow-up analysis of a Phase 4 single-arm clinical study that evaluated 60 open-angle glaucoma patients, iDose TR implanted in combination with cataract surgery achieved a mean IOP reduction of 11.3 mmHg, or 44%, at 6 months compared to baseline.

We are pleased to share these positive clinical updates on our iDose procedural pharmaceutical platform, helping to further advance our goal to position iDose as a transformative novel platform technology able to fundamentally improve the treatment paradigm for patients with glaucoma or ocular hypertension,” said Thomas Burns, Glaukos chairman and chief executive officer. “We continue to believe 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. These clinical updates leave us ideally positioned to advance our mission to transform vision therapies for the benefit of patients around the globe suffering from chronic eye diseases.

Glaukos’ iDose sustained-release procedural pharmaceutical platform consists of a targeted, minimally-invasive, injectable implant designed to deliver therapeutic levels of medication from within the eye for extended periods of time. The iDose platform is designed to address ubiquitous patient non-adherence and chronic side effects associated with topical medications by providing 24/7, long-duration, robust efficacy with minimal side effects. Given Glaukos’ development success to date with iDose TR, the company continues to invest resources to expand its pharmaceutical development capabilities and develop future iDose solutions.