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 established a direct sales organization and launched the iStent inject® Trabecular Micro-Bypass Stent in Australia.
The iStent inject is approved by the Australian Therapeutics Goods Administration for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild-to-moderate glaucoma currently treated with ocular hypotensive medication. The iStent inject system is preloaded with two micro-scale stents that the surgeon places though a single corneal entry point into multiple trabecular meshwork locations using a 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.
Numerous clinical studies have shown that implantation of stents with concomitant cataract surgery can help glaucoma patients achieve target IOP levels while significantly reducing their dependence on topical medications, which are often ineffective due to high rates of patient non-compliance. According to results of a comparative case series published in the November 2012 issue of the Journal of Cataract & Refractive Surgery, 28 patients who received two trabecular micro-bypass stents in combination with cataract surgery achieved mean postoperative IOP of 13.8 mm Hg at one year, compared to a mean preoperative medicated IOP of 17.3 mm Hg. Over the same period, patients’ mean glaucoma medication use declined from 2.8 to 1.0 medications.
“The iStent inject stents are placed directly into the eye’s drainage canal, restoring natural physiological fluid outflow in a straightforward procedure with an excellent safety profile,” said Frank Howes, MD, a Brisbane-based ophthalmic surgeon who was the first Australian physician to implant the iStent inject. “The iStent inject represents an important new advancement for effectively managing glaucoma patients’ IOP and potentially reducing or eliminating their need for daily, multi-dose topical glaucoma medications or complex surgeries.”
Glaukos introduced Micro-Invasive Glaucoma Surgery (MIGS) to the Australian market when it launched its flagship iStent® Trabecular Micro-Bypass Stent in Australia in 2014. With the 2016 launch of its next-generation iStent inject, the company is now increasing its presence in the region with a direct sales organization that is headquartered in Melbourne and provides full market coverage through account managers in Sydney, Brisbane and Melbourne. The seven-person Glaukos Australian 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 excited about the opportunity to bring innovative MIGS solutions to Australian ophthalmic surgeons and their glaucoma patients,” said Thomas Burns, Glaukos president and chief executive officer. “Our investment in Australia demonstrates our continued commitment to expand our direct sales operations in targeted markets and increase the global reach of our breakthrough iStent technology platform.”
According to Glaucoma Australia, a not-for-profit glaucoma awareness, education and support association, more than 300,000 people in Australia suffer from glaucoma, which is characterized by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. There is no cure for the disease and reducing intraocular pressure is the only proven treatment.
About Glaukos
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.
Forward-Looking Statements
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 Australia 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.
