Study Shows Long-Term Titrated IOP Control With Glaukos iStent Trabecular Micro-Bypass Stents

Glaukos Corporation, an ophthalmic medical technology company focused on the development and commercialization of glaucoma treatment products and procedures, said a study showed implantation of one, two or three iStent Trabecular Micro-Bypass Stents achieved mean unmedicated intraocular pressure (IOP) reductions of 30 percent, 37 percent, and 43 percent, respectively, at 36 months postoperative.
 
In this prospective, randomized study conducted by multiple surgeons at a single investigational site, 119 open-angle glaucoma (OAG) subjects with preoperative unmedicated IOP of 22 mmHg to 38 mmHg received one, two or three iStents in a standalone procedure. At approximately 36 months postoperative, the one-, two-, and three-stent groups achieved unmedicated (post-washout) mean IOP of 17.4 mmHg, 15.8 mmHg and 14.2 mmHg, respectively, compared to preoperative unmedicated mean IOP of 25.0 mmHg for the one- and two-stent groups and 25.1 mmHg for the three-stent group. At 42 months, 61 percent, 91 percent, and 91 percent of eyes in the one-, two-, and three-stent groups, respectively, achieved a ≥20 percent reduction in IOP without medication.
 
“The latest results of this ongoing study further underscore the durable and substantial IOP-lowering and medication-reducing effects of one or multiple iStents in mild-to-moderate glaucoma patients,” said L. Jay Katz, M.D., FACS, who co-authored the study. Katz is the director of Glaucoma Service at the Wills Eye Hospital and is Glaukos’ chief medical officer. “Moreover, the study’s findings corroborate the data of prior laboratory investigations and clinical studies, making clear that the most significant portion of the IOP reduction results from implantation of the first stent, with each additional stent providing additional incremental benefits.”
 
According to the study authors, no intraoperative or perioperative complications were reported. During 42 months of postoperative follow-up, the most commonly reported adverse event was progression of pre-existing cataract. However, no eyes required additional glaucoma surgery.
 
Study subjects will continue to be followed for a total of 60 months.
 
“At Glaukos, we have long believed in the potential to titrate MIGS technologies in order to effectively manage glaucoma patients’ IOP based on their specific clinical needs,” said Thomas Burns, Glaukos president and CEO. “While the indication for our current iStent device is for implantation of a single stent in mild-to-moderate glaucoma patients undergoing cataract surgery, these latest study results help to illustrate the value of ultimately providing surgeons a comprehensive array of single- and multi-stent MIGS devices designed to address a full range of glaucoma disease states and progression.”
 
Glaukos is the study sponsor and the pioneer of Micro-Invasive Glaucoma Surgery, or MIGS. The company’s iStent was approved by the U.S. Food and Drug Administration (FDA) in 2012. Inserted through a small corneal incision made during cataract surgery, the iStent is designed to reduce IOP in mild-to-moderate OAG patients by restoring the natural physiological outflow of aqueous humor through the trabecular meshwork and into Schlemm’s canal, the eye’s primary drainage channel. Glaukos is currently pursuing FDA approvals for five additional MIGS surgical and sustained pharmaceutical therapy pipeline products:
 

• iStent inject Trabecular Micro-Bypass System, which is designed for use during cataract surgery and allows a surgeon to inject stents into two trabecular meshwork locations through a single corneal entry point. The iStent inject is approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, and South America.
• iStent SA Trabecular Micro-Bypass System, which is a standalone, two-stent procedure that is similar to the iStent inject and designed to reduce IOP in pseudophakic, mild-to-moderate OAG eyes.
• iStent infinite Trabecular Micro-Bypass System, which is a standalone, three-stent procedure, designed to reduce IOP in refractory OAG patients.
• iStent Supra Suprachoroidal Micro-Bypass Stent, which is designed to reduce IOP by accessing the eye’s suprachoroidal space and is approved in the European Union.
• iDose Travoprost, which is an implant containing a special formulation of travoprost, a prostaglandin analog used to reduce IOP. Implanted during a micro-invasive procedure, the iDose Travoprost is designed to continuously elute therapeutic levels of the medication from within the eye for extended periods of time. When depleted, it can be removed and replaced in a similar, subsequent procedure.

 
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. Based on analysis of population-based surveys, medical claims data and other statistics, the company estimates that there are approximately 5.4 million people in the United States with primary OAG, the most common form of the disease.
 
The iStent Trabecular Micro-Bypass Stent is indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild-to-moderate OAG currently treated with ocular hypotensive medication.
 
Glaukos develops and commercializes glaucoma treatment products and procedures. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, 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 1.0 mm long and 0.33 mm wide, is the smallest medical device ever approved by the FDA.