LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, today announced that it has created a direct sales organization and initiated the commercial launch of the iStent inject® Trabecular Micro-Bypass Stent in Canada.
The iStent inject system is preloaded with two micro-scale stents that the surgeon places through a single corneal entry point directly into the eye’s drainage canal to restore the natural, physiological outflow of fluid and reduce intraocular pressure (IOP). The iStent inject has been designed to allow placement of stents into multiple trabecular meshwork locations with a straightforward click-and-release motion. Made from surgical-grade non-ferromagnetic titanium that is coated with heparin, each iStent inject stent is approximately 0.3 mm in diameter and 0.4 mm long.
The iStent inject is approved by Health Canada for IOP reduction in patients diagnosed with primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma, and may be used in combination with cataract surgery or in a standalone procedure.
In numerous clinical studies, implantation of multiple stents reduced patients’ IOP while potentially reducing or eliminating the need for topical medications, which are often ineffective due to high rates of patient non-compliance. In a prospective trial conducted in six European countries and published in Clinical Ophthalmology, 192 subjects were randomized to receive two iStent inject stents or topical medication therapy. At 12 months, 94.7% of eyes in the stent group (n = 89 of 94) achieved a ≥20% reduction in unmedicated IOP versus baseline unmedicated IOP. This compared to 91.8% of eyes in the medication therapy group (n = 88 of 98) that achieved a ≥20% IOP reduction versus baseline unmedicated IOP. The study authors concluded that use of iStent inject was at least as effective as two medications, with the added clinical benefits of reducing medication burden, facilitating treatment with compliance and providing a highly favorable safety profile.
“The advent of Micro-Invasive Glaucoma Surgery, or MIGS, is revolutionizing the way we treat glaucoma patients and the commercial launch of iStent inject in Canada underscores the continuing advance of this exciting new treatment class,” said Ike K. Ahmed, MD, FRCSC, Trillium Health Partners and University of Toronto. Dr. Ahmed was the first surgeon in Canada to implant the iStent inject in patients.
Glaukos introduced MIGS to the Canadian market in 2009 with the release of its flagship iStent® Trabecular Micro-Bypass Stent. With the launch of iStent inject, the company is strengthening its presence in Canada with a direct sales organization that is headquartered in Toronto and provides full national coverage through account managers located in Vancouver, Calgary, Toronto and Montreal. The Glaukos Canada team is primarily responsible for training ophthalmic surgeons on the iStent inject procedure and helping these physicians integrate the technology into their practices.
“We are enthusiastic about the opportunity to bring the latest MIGS technologies to Canadian ophthalmic surgeons and their patients,” said Thomas Burns, Glaukos president and chief executive officer. “Our investment in Canada demonstrates our continuing commitment to expand our direct sales operations in targeted markets and extend the global reach of our innovative glaucoma solutions.”
The Glaucoma Research Society of Canada estimates that glaucoma affects more than 400,000 Canadians. Glaucoma is characterized by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. Open-angle glaucoma is the most common form of the disease. There is no cure for glaucoma and reducing IOP is the only proven treatment.
Glaukos (www.glaukos.com) is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures to transform the treatment of glaucoma, one of the world’s leading causes of blindness. 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.
All statements other than statements of historical facts included in 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. These include statements about our plans, objectives, strategies and prospects regarding, among other things, the safety and efficacy of our current products, the extent to which our products will be adopted in Canada, and our ability to increase our presence through direct sales operations. 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 events affecting us and are subject to risks, uncertainties and factors 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 are described in detail under the caption “Risk Factors” and elsewhere in our filings with the Securities and Exchange Commission (SEC), including our most recent Quarterly Report on Form 10-Q. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.