Glaukos announced that a study published in Clinical Ophthalmology showed that two iStent Trabecular Micro-Bypass Stents and one topical ocular hypotensive medication achieved a 38% reduction in mean medicated IOP 3 years following surgery in 37 phakic eyes. Phakic refers to eyes that have not undergone prior cataract surgery and still have a natural lens.
This prospective study, conducted at a single international site, enrolled patients with open-angle glaucoma (OAG) not controlled on two topical medications and with unmedicated IOP of 22-38 mm Hg. All patients in the study received two iStents in a standalone procedure, and began daily use of topical travoprost 1 day after surgery. Through three years, 86% of eyes achieved IOP ≤ 18 mm Hg. Mean medicated IOP in these eyes decreased to 14.0 mm Hg on one medication, versus 22.4 mm Hg on two medications preoperatively. The safety profile was favorable with no intraoperative or device-related adverse events reported.
These 3-year results update 18-month data from the same study that was published in 2014 in the Journal of Cataract and Refractive Surgery. In that publication, follow-up through 18 months showed a decrease in medicated IOP to 14 mm Hg or less on one medication, versus 22.2 mm Hg on two medications preoperatively. Study researchers plan to continue to follow patients through five years postoperative.
“The 3-year data demonstrate the long-term performance and safety of trabecular bypass stents and topical travoprost in subjects with OAG not controlled on two medications,” David F. Chang, MD, who authored the Clinical Ophthalmology article, said in a company news release. “In addition, our results support the hypothetical synergy of using trabecular stents to increase outflow through the conventional aqueous fluid pathway while also using a prostaglandin analog such as topical travoprost to increase outflow through the uveoscleral, or unconventional, pathway.”