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 one day after surgery. Through three years, 86 percent of eyes achieved IOP ≤ 18 mm Hg. Mean medicated IOP in these eyes decreased to 14 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 three-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 three-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,” said David F. Chang, M.D., who authored an article about the study in Clinical Ophthalmology. “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.”
Glaukos is the study sponsor and the developer of micro-invasive glaucoma surgery, or MIGS. The iStent was approved by the U.S. Food and Drug Administration (FDA) in 2012 and is the industry’s flagship MIGS device. Inserted through the trabecular meshwork and into Schlemm’s canal via a small corneal incision made during cataract surgery, the iStent is designed to restore the natural, physiological outflow of aqueous fluid through the conventional pathway and reduce IOP. The company also is pursuing FDA approval of two versions of its next-generation iStent inject Trabecular Micro-Bypass device: one for use in combination with cataract surgery and another for use in a standalone procedure. The iStent inject is designed to deploy two stents into separate trabecular meshwork locations and is being evaluated in FDA clinical trials for IOP reduction. The company also is pursuing FDA approval of a third MIGS device, the iStent SUPRA, which accesses the uveoscleral pathway for aqueous humor outflow.
“Our fundamental goal is to transform glaucoma therapy by providing ophthalmic surgeons and their patients a full complement of micro-scale glaucoma technologies that deliver sustained reductions in IOP and topical medication use,” said Thomas Burns, Glaukos president and CEO. “Study results like these help to strengthen our view that future glaucoma therapy may ultimately involve use of multiple stents and multiple pathways for aqueous fluid outflow to manage patients’ IOP and disease progression.”
Glaucoma is characterized by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. There is no cure for the disease and reducing IOP is the only proven treatment. According to Market Scope, more than 80 million people worldwide have glaucoma, including 4.5 million people in the United States. Open-angle glaucoma is the most common form, affecting approximately 3.6 million people in the United States.
The iStent Trabecular Micro-Bypass Stent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild-to-moderate open-angle glaucoma currently treated with ocular hypotensive medication.
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world’s leading causes of blindness. The company pioneered micro-invasive glaucoma surgery to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in July 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company believes the iStent, measuring 1 mm long and 0.33 mm wide, is the smallest medical device ever approved by the FDA.