Approvals in Australia, South Korea and Taiwan Expand Reach in Asia Pacific Region
Glaukos Corporation, an ophthalmic medical technology company that develops and markets breakthrough glaucoma products, has secured regulatory approval of its iStent® Trabecular Micro-Bypass Stent for use in Australia, South Korea and Taiwan. With these latest additions, the iStent® is now available in 17 countries, including the United States where it received FDA approval in 2012.
Regulatory agencies in Australia, South Korea and Taiwan approved the iStent® for use in conjunction with cataract surgery for the reduction of intraocular pressure in adult patients with open-angle glaucoma. The iStent® is inserted through the small corneal incision made during cataract surgery and placed into Schlemm's canal, a circular channel in the eye that collects aqueous humor and delivers it back into the bloodstream. Once inserted, the iStent® improves aqueous humor outflow while fitting naturally with Schlemm's canal. The iStent® has been clinically proven to decrease intraocular pressure when inserted in combination with cataract surgery.
The iStent® is designed to establish continuous outflow of aqueous fluid and allow uninterrupted therapy that overcomes patient non-compliance with prescription eye drop regimens. Moreover, clinical studies have shown that inserting the iStent® in combination with cataract surgery yields an overall safety profile and recovery rate similar to cataract surgery alone.
The iStent® is the first commercially available Micro-Invasive Glaucoma Surgery (MIGS) device. Glaukos developed MIGS to address the shortcomings of traditional glaucoma treatment options. 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-tomoderate 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.