Glaukos announced that an international study published in Ophthalmology and Therapy showed that newly diagnosed primary open-angle glaucoma patients achieved a 43% reduction in mean IOP to 14.6 mm Hg through 36 months following implantation of two iStent Trabecular Micro-Bypass stents in a standalone procedure, according to a company news release.
In this prospective study conducted by multiple ophthalmic surgeons at a single investigational site, 101 phakic subjects with primary open-angle glaucoma that had not undergone prior glaucoma treatment of any kind were randomized in a 1:1 ratio to receive either two iStents in a standalone procedure or topical ocular hypotensive medication therapy (travoprost). Phakic refers to eyes that have not undergone prior cataract surgery and contain a natural lens. The study is designed for follow-up of all subjects through 5 years. Through 36 months, study results showed:
- Mean IOP in the stent group (n=39) declined 43% from 25.5 mm Hg to 14.6 mm Hg, while mean IOP in the travoprost group (n=34) declined 39% from 25.1 mm Hg to 15.3 mm Hg.
- 11% of eyes in the stent group required additional topical medication therapy, compared to 23% in the travoprost group.
- 91% of eyes in the stent group had IOP ≤18 mm Hg without additional topical medication therapy, compared to 79% of eyes in the travoprost group; 62% of eyes in the stent group had IOP ≤15 mm Hg without additional topical medication therapy, compared to 21% of eyes 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,” Steven D. Vold, MD, said in the news release. “Three-year safety and efficacy data are promising and show that two 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.”
The article may be accessed online at https://link.springer.com/article/10.1007%2Fs40123-016-0065-3.