FDA Clears Glaucoma Laser from Iridex

Mountain View, Calif.-based Iridex Corporation has received 510(k) clearance from the U.S. Food and Drug Administration for its laser system designed solely for use in treating glaucoma and its symptoms. The Iridex Cyclo G6 laser system (with delivery devices). The Cyclo G6 laser system is dedicated specifically to treat patients diagnosed with a range of glaucoma disease states and features the company’s proprietary Micropulse tissue-sparing technology and a family of single use probes that connect to an intuitive, user-friendly laser console.

Glaucoma is the leading cause of irreversible blindness in adults. It is estimated that more than 4 million people in the United States and approximately 60 million worldwide are afflicted with glaucoma today. That number is increasing with the worldwide epidemic of obesity and diabetes. Of the millions that have the disease, it is estimated by the Glaucoma Research Foundation that less than half know they have it and are undergoing treatment. It is estimated that in terms of Social Security benefits, lost income tax revenues, and health care expenditures, the cost to the U.S. government is estimated to be more than $2 billion annually.

“MicroPulse allows for a clinically effective and repeatable option that can slow the progression of the disease and delay both surgical intervention and ultimate blindness,” said glaucoma and cataract specialist Robert Noecker, M.D. of the Ophthalmic Consultants of Connecticut.

The Cyclo G6 laser system will initially be sold with two disposable delivery probes, the Micropulse P3 probe and the G-Probe. The company plans a series of additional new probe introductions in the coming year that allow for a broader range of application in glaucoma treatment.

“The Cyclo G6 system extends the reach of Iridex’ proprietary Micropulse technology to a broader group of ophthalmologists who are seeking better alternatives for treating glaucoma than drug regimens or invasive surgical procedures,” said William Moore, Iridex president & CEO. ‘That added reach, combined with the recurring use of specialty probes associated with the Cyclo G6, is expected to help drive growth in an important recurring revenue component of our business.”

Iridex makes laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology market.