Glaukos (NYSE:GKOS) today released 3-year results from a study of its iStent trabecular micro-bypass stents, touting a 43% reduction in mean intraocular pressure in glaucoma patients treated with the device.
Results were published in the journal Ophthalmology and Therapy this month, the Laguna Hills, Calif.-based company said.
Glaukos’ 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, the company said.
Data in the prospective study came from 101 patients with primary open-angle glaucoma at a single investigational site, who received either 2 iStents or topical travoprost. Results indicated a mean IOP reduction of 43% for patients treated with the iStent, reduced from 25.5 mm Hg to 14.6 mm Hg. Data from the travoprost arm indicated a 39% reduction in IOP, moving from 25.1 mm Hg to 15.3 mm Hg.
A total 23% of the patients treated with travoprost required additional topical medication therapy, compared with 11% of patients treated with iStent, according to the study. Mean intraocular pressure was reported at 18 mm Hg or below for 91% of the patients in the stent group without the need for additional topical meds, and 79% for patients in the travoprost group.
“We embarked on this study to assess the potential utility of iStent as an initial treatment in naïve open-angle glaucoma patients versus topical travoprost, which is a commonly prescribed first-line medication therapy. Three-year safety and efficacy data are promising and show that 2 iStents achieved sustained IOP reduction, with fewer subjects requiring additional topical medication therapy compared to topical travoprost. These results indicate that iStent implantation as initial therapy in newly diagnosed glaucoma patients may be a viable alternative to topical ocular hypotensive medications, which are often associated with high rates of non-compliance, side effects and/or ocular surface damage,” lead author Dr. Steven Vold said in prepared remarks.
In March, Glaukos said that the Japanese Ministry of Health, Labor & Welfare approved its iStent device for treating glaucoma.
The company said the approval covers use of the iStent in conjunction with cataract surgery, making it the 1st within-the-eye micro-invasive glaucoma surgery device to hit the market in Japan.
The device is designed to be inserted via a small corneal incision into the Schlemm’s canal to restore the eye’s ability to drain aqueous fluid and relieve intraocular pressure. Glaukos won pre-market approval from the FDA for the iStent in 2012.