Prospective, Randomized Trial Highlights 5-Year Performance of 2 Standalone Glaukos iStents vs. Topical Prostaglandin in Newly Diagnosed Glaucoma Patients

Glaukos Corporation (NYSE:GKOS), an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, announced today that results of an international glaucoma study published in Ophthalmology Glaucoma showed standalone implantation of two iStent Trabecular Micro-Bypass Stents in newly diagnosed primary open-angle glaucoma (POAG) eyes achieved a 35.3% reduction in mean intraocular pressure (IOP) to 16.5 mmHg after five years of follow-up.

The purpose of this prospective, randomized, controlled, multi-surgeon clinical trial was to evaluate the five-year safety and efficacy of two iStents vs. topical prostaglandin as an initial intervention in POAG subjects who had not had prior glaucoma treatment of any kind. A total of 101 subjects were randomized in a 1:1 ratio to receive either two iStents in a standalone procedure or once-daily topical travoprost, a commonly prescribed prostaglandin. At five years, results showed:

• Mean diurnal IOP was 16.5 mmHg (35.3% reduction; p < 0.0001) for the stent group vs. 16.3 mmHg (35.1% reduction) for the travoprost group, excluding eyes in both cohorts that underwent cataract surgery during follow-up.
• Treatment success – defined as mean diurnal IOP of 6 mmHg to 18 mmHg without add-on medication or secondary glaucoma surgery – was achieved in 77% of stent eyes vs. 53% of travoprost eyes (p = 0.04).
• Seventeen percent of stent eyes vs. 44% of travoprost eyes required add-on medication.
• The need for add-on medication arose at a slower rate in the stent group than in the travoprost group, especially after two years of follow-up. Study authors observed that from two to five years of follow-up, add-on medications were initiated in roughly double the number of travoprost eyes vs. stent eyes.
• The safety profile was excellent in both groups throughout follow-up.

“These results illustrate the enduring efficacy and safety of using multiple trabecular bypass stents in a standalone procedure as initial intervention to manage IOP in newly diagnosed, treatment-naïve glaucoma patients,” said Robert D. Fechtner, MD, an ophthalmic surgeon based in Syracuse, NY and lead author of the Ophthalmology Glaucoma article. “Topical ocular hypotensive medications are typical first-line glaucoma therapy but these drugs can be ineffective due to high rates of patient non-adherence, ocular surface damage, cost and other factors. This study shows that not only are Glaukos’ iStents as effective as once-daily topical travoprost in controlling IOP, but they also succeed at maintaining IOP reductions over the long-term with fewer additional medications.”