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Glaukos’ iStent Has Strong Showing in 5-Year Data

Results from the prospective, randomized, controlled, multi-surgeon clinical trial were published in Ophthalmology Glaucoma.

Glaukos’ iStent still holds up after five years, according to results from an international glaucoma study published in Ophthalmology Glaucoma. Results 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.

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.

Mean diurnal IOP was 16.5 mmHg for the stent group vs. 16.3 mmHg 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.

Results also show that 17% of stent eyes vs. 44% of travoprost eyes required add-on medication.

In addition, 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.

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,” Robert D. Fechtner, MD, an ophthalmic surgeon based in Syracuse, NY and lead author of the Ophthalmology Glaucoma article, said in a release. “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.”

The San Clemente, CA-based company has been on full court press for a while now. Earlier this year, at the 37th annual J.P. Morgan Healthcare Conference, the company unveiled a series of products and initiatives that would see it transition into a hybrid surgical, pharmaceutical, and medical device company.

 

 

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