Glaukos Corporation (GKOS) Announces Publication of Positive iStent Data in Reducing IOP
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Glaukos Corporation (NYSE: GKOS) announced that a study published in Clinical Ophthalmology showed that a consistent cohort of 107 open-angle glaucoma (OAG) eyes receiving the iStent Trabecular Micro-Bypass Stent in combination with cataract surgery achieved a 22% reduction in mean intraocular pressure (IOP) to 15.17 mm Hg and a 56% reduction in mean ocular hypotension medications to 0.61 two years following surgery.
The retrospective, consecutive case series includes 350 eyes that underwent iStent implantation with concomitant cataract surgery between October 2012 and December 2015. Study researchers reported a favorable safety profile and postoperative follow-up of all eyes is ongoing. All procedures were performed by John P. Berdahl, MD, at a single site in Sioux Falls, South Dakota. The series represents Dr. Berdahl’s typical clinical use of the iStent. In this study, OAG subjects were defined as patients with primary OAG, normal tension glaucoma and ocular hypertension, with no cases excluded.
“Our data show that mild-to-moderate OAG patients receiving a single iStent with cataract surgery can achieve sustained IOP levels approaching 15 mm Hg and also reduce their dependence on glaucoma medications,” said Dr. Berdahl. “These outcomes are important because controlling IOP is the only proven treatment for glaucoma and its management is often hindered by the poor compliance, cost and side effects associated with topical ocular hypotensive medications that patients must administer one or more times a day for the rest of their lives.”
Study researchers indicated that, to their knowledge, this study represents the largest sample size published to date regarding the iStent in combination with cataract surgery. The full Clinical Ophthalmology article is available online at https://www.dovepress.com/clinical-evaluation-of-a-trabecular-microbypass-stent-with-phacoemulsi-peer-reviewed-article-OPTH.
Typically associated with elevated IOP, glaucoma is characterized by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. It is a leading cause of blindness. 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 was approved by the U.S. Food & Drug Administration (FDA) in June 2012 and is indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild-to-moderate open-angle glaucoma currently treated with ocular hypotensive medication. The iStent is inserted through the trabecular meshwork and into Schlemm’s canal, the eye’s drainage system, where it restores the natural, physiological outflow of aqueous humor. Made of surgical-grade non-ferromagnetic titanium that is coated with heparin, the iStent is approximately 1.0 mm long and 0.33 mm wide. Glaukos believes it is the smallest medical device ever approved by the FDA.
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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