Glaukos (NYSE:GKOS) today released results from a study of its iStent trabecular micro-bypass stent exploring its use during cataract surgery in patients with severe open-angle glaucoma, touting significant reductions in intraocular pressure and medication use.
The San Clemente, Calif.-based company’s iStent micro-bypass stents are made from non-ferromagnetic titanium and coated in heparin, is designed to be implanted into multiple trabecular meshwork through a single corneal entry point to reduce IOP.
Results were published in the January issue of the Journal of Glaucoma.
“Although the iStent is currently indicated for use in the United States during cataract surgery in mild to moderate glaucoma patients, this study offers important insights into the potential for ourtechnology platform to ultimately serve a full range of glaucoma disease states and progression,” prez & CEO Thomas Burns said in a prepared statement.
Data in the study came from 59 glaucomatous eyes with cataracts and severe visual field loss, recording a baseline medicated mean IOP of 19.3 mm Hg and mean topical glaucoma medication use per eye of 2.3.
A total of 49 eyes were followed out to two years after implantation, with mean postoperative IOP decreasing to 14.9 mm Hg and mean glaucoma medication use dropping to 1.6. IOP reduction was maintained in a consistent cohort of 32 eyes with data available through three years, with a postoperative IOP of 14.1, down from 18.1.
No intraoperative complications were noted among 59 eyes in the series, with four patients requiring additional surgery.
“While many prior studies have documented the clinical benefits of combining iStent implantation with cataract surgery in glaucoma patients who are in the mild to moderate stage of the disease, we believe this is the first published study to focus on its use in severe glaucoma patients undergoing cataract surgery. Our study showed that severe glaucoma patients experienced sustained reductions in IOP and medication use through three years postoperative,” study author Dr. John Berdahl said in a press release.
Last month, Glaukos released results from a Phase II trial of its travoprost intraocular implant in a 12-month cohort of glaucoma patients.