Glaukos Corporation, an ophthalmic medical technology company that develops and markets breakthrough glaucoma products, has initiated a controlled launch in Germany of its iStent inject® Trabecular Micro-Bypass Stent, which is designed to lower intraocular pressure in patients with mild-to-moderate glaucoma.
The iStent inject® is similar to the Glaukos iStent® Trabecular Micro-Bypass Stent, which has been commercially available since its approval by the U.S. Food & Drug Administration (FDA) in 2012 and has been shown to reduce intraocular pressure by restoring the natural outflow pathway for aqueous humor. The iStent inject® is packaged in a two-stent, preloaded, autoinject mechanism. This allows the surgeon to inject the stents into multiple trabecular meshwork locations through a single corneal entry with the goal of achieving even greater levels of intraocular pressure reduction.
The iStent inject® is made of surgical-grade non-ferromagnetic titanium that is coated with heparin. Measuring 360 μm long and 230 μm wide, it is approximately one-third the size of the iStent®, which is the smallest device ever approved by the FDA. The iStent inject® received CE Mark clearance in 2010. A pivotal U.S. IDE clinical trial for approval by the FDA is underway.
Like the iStent®, the iStent inject® is used in Micro-Invasive Glaucoma Surgery (MIGS), which involves the insertion of a micro-scale device from within the eye's anterior chamber through a small corneal incision. Glaukos pioneered MIGS to address the shortcomings of traditional glaucoma treatment options. These include prescription eye drops, which can lower intraocular pressure but are often ineffective due to high rates of patient non-compliance with daily dosing regimens, and invasive surgery, which carries significant failure and complication risks.
"Glaukos is dedicated to providing ophthalmic surgeons and their patients with MIGS-based technologies that effectively manage intraocular pressure, reduce or eliminate patients' reliance on prescription eye drops and help to slow glaucoma's progression," said Tom Burns, Glaukos chairman and chief executive officer. "The controlled launch of iStent inject is another important step towards our objective to advance the MIGS platform and further transform glaucoma care."
Industry experts estimate that 78 million people worldwide have glaucoma and project the incidence to rise to more than 88 million by 2019. The majority of patients have mild-to- moderate glaucoma. Despite therapeutic options that attempt to manage disease progression, researchers estimate that 8.4 million people were bilaterally blind from glaucoma in 2010.
About Glaukos
Glaukos is a privately held 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. Glaukos pioneered Micro-Invasive Glaucoma Surgery (MIGS) to revolutionize the traditional glaucoma treatment and management paradigm and launched iStent®, its first MIGS device, in the United States in 2012. Measuring 1.0 mm long and 0.33 mm wide, the iStent® is the smallest medical device ever approved by the FDA. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of injectable micro-scale devices designed to address the complete range of glaucoma disease states and progression. The company is based in Laguna Hills, CA. For more information, visit www.glaukos.com.