Glaukos iStent Trabecular Micro-Bypass Stent Approved in Japan

Glaukos Corporation said the Japanese Ministry of Health, Labor and Welfare (MHLW) approved its iStent Trabecular Micro-Bypass Stent for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients diagnosed with mild to moderate open-angle glaucoma who are currently treated with ocular hypotensive medication. The iStent is the first ab interno Micro-Invasive Glaucoma Surgery (MIGS) device approved for use in Japan.

Glaukos pioneered MIGS to address the shortcomings of conventional glaucoma treatment options, which include chronic use of daily prescription eye drops or invasive surgeries.

Packaged in a pre-loaded configuration, the iStent is inserted through a small corneal incision made during cataract surgery and placed into Schlemm’s canal, a circular channel in the eye that collects aqueous humor and eventually delivers it into the bloodstream. If aqueous humor cannot drain appropriately through the trabecular meshwork and Schlemm’s canal, pressure within the eye (IOP) can become elevated. The iStent is designed to restore the natural outflow pathways for aqueous humor and provide sustained IOP reduction. Clinical studies have demonstrated that inserting the iStent in combination with cataract surgery yields an overall safety profile and recovery rate similar to cataract surgery alone. Cataract surgery has minimal complications and is the most commonly performed ophthalmic procedure today.

The iStent was approved by the U.S. Food and Drug Administration (FDA) in June 2012 and is currently approved for sale in 27 countries worldwide. Made of surgical-grade non-ferromagnetic titanium that is coated with heparin, the iStent is approximately 1.0 mm long and 0.33 mm wide. Glaukos executives believe it is the smallest device ever approved by either the FDA or MHLW.

“The iStent represents an important new option for effectively managing elevated IOP in glaucoma, a disease that is a leading cause of blindness worldwide,” said Thomas Burns, Glaukos president and CEO. “We appreciate the efforts of the MHLW to evaluate and approve the iStent and we are eager to introduce this breakthrough MIGS technology to Japanese surgeons and patients. This achievement also marks an important milestone for Glaukos as we expand our presence in the Asia Pacific region.”

In anticipation of the iStent approval, Glaukos recently established a direct commercial team and formed a wholly owned subsidiary in Japan. The company expects to officially launch the iStent in Japan later this year once the iStent procedure is approved for reimbursement by MHLW.

According to market data, glaucoma affects approximately 3 million people in Japan. Glaucoma is characterized by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. Primary 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 is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures to improve 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 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.