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 regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its iStent inject® Trabecular Micro-Bypass Stent.
With TGA approval, the iStent inject is now indicated for use in Australia 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 relies on a similar fluidic method of action as the company’s flagship iStent® Trabecular Micro-Bypass Stent, which was approved by the TGA in 2014. Packaged in a two-stent, preloaded, auto-inject mechanism, the iStent inject allows an ophthalmic surgeon to inject stents into multiple trabecular meshwork locations through a single corneal entry point for greater IOP reduction. 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, or roughly one-third the size of the original iStent.
“The iStent inject is designed to make it more straightforward for a surgeon to implant two stents in a facile click-and-release motion, providing an important new tool for effectively managing patients’ IOP,” said Thomas Burns, president and CEO of Glaukos. “This approval strengthens our offering to Australian surgeons and patients, and underscores our commitment to expand our presence in the Asia Pacific region.”
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 IOP is the only proven treatment.
The iStent inject is already approved in the European Union and an initial commercial launch is underway in Germany. Glaukos is also pursuing regulatory approval in other countries, including the United States where the company is conducting IDE clinical trials to evaluate two versions of the iStent inject, one in combination with cataract surgery and another as a standalone procedure in phakic and pseudophakic glaucoma patients.
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, our iStent and iStent inject® products, efforts to secure regulatory approvals, and U.S. and international commercialization efforts. 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. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this presentation. 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. The known risks, uncertainties and factors are described in detail under the caption “Risk Factors” and elsewhere in our filings with the Securities and Exchange Commission (SEC) and available in the Investor section of our website at www.glaukos.com or at www.sec.gov.