International Study Shows Favorable 3-Year Results of 2 Glaukos iStent® Trabecular Micro-Bypass Stents as Initial Treatment for Na?ve Glaucoma
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 five 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 na?ve open-angle glaucoma patients versus topical travoprost, which is a commonly prescribed first-line medication therapy,” said
Steven D. Vold, MD. “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 http://link.springer.com/article/10.1007%2Fs40123-016-0065-3.
Approved by the
The company’s next-generation MIGS device, the iStent inject®
Trabecular Micro-Bypass Stent includes two stents preloaded in an
auto-injection mechanism that allows an ophthalmic surgeon to inject
stents into multiple trabecular meshwork locations through a single
corneal entry point. The iStent inject has been approved in the
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
About iStent Trabecular Micro-Bypass Stent (U.S.)
Indication for Use: 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.
Contraindications: The iStent is contraindicated in eyes with primary or secondary angle closure glaucoma, including neovascular glaucoma, as well as in patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
Warnings: Gonioscopy should be performed prior to surgery to exclude PAS, rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. The iStent is MR-Conditional meaning that the device is safe for use in a specified MR environment under specified conditions, please see label for details.
Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the iStent has not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, chronic inflammation, or an abnormal anterior segment, in pseudophakic patients with glaucoma, in patients with pseudoexfoliative glaucoma, pigmentary, and uveitic glaucoma, in patients with unmedicated IOP less than 22 mmHg or greater than 36 mmHg after “washout” of medications, or in patients with prior glaucoma surgery of any type including argon laser trabeculoplasty, for implantation of more than a single stent, after complications during cataract surgery, and when implantation has been without concomitant cataract surgery with IOL implantation for visually significant cataract.
Adverse Events: The most common post-operative adverse events reported in the randomized pivotal trial included early post-operative corneal edema (8%), BCVA loss of ? 1 line at or after the 3 month visit (7%), posterior capsular opacification (6%), stent obstruction (4%), early post-operative anterior chamber cells (3%), and early post-operative corneal abrasion (3%). Please refer to Directions for Use for additional adverse event information.
Caution: Federal law restricts this device to sale by, or on the order of, a physician. Please reference the Directions for Use labeling for a complete list of contraindications, warnings, precautions, and adverse events.
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this press release that address activities, events or developments that
we expect, believe or anticipate will or may occur in the future are
forward-looking statements. Although we believe that we have a
reasonable basis for forward-looking statements contained herein, we
caution you that they are based on current expectations about future
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relating to our operations and business environment, all of which are
difficult to predict and many of which are beyond our control, that may
cause our actual results to differ materially from those expressed or
implied by forward-looking statements in this press release. These
potential risks and uncertainties include, without limitation, our
ability to receive additional approvals of our products, including,
without limitation, the iStent inject® Trabecular Micro-Bypass Stent,