Iridex (NSDQ:IRIX) said today it won CE Mark approval in the European union for its Cyclo G6 laser system designed to treat patients with Glaucoma.
The Cyclo G6 system is designed specifically for treating patients diagnosed with “a range of glaucoma disease states” and features Mountain View, Calif.-based Iridex’ MicroPulse tissue-sparing technology as we ll as single use probes.
“This regulatory approval marks a milestone for the glaucoma community and strengthens our portfolio to treat patients with difficult glaucoma conditions who need fast relief from uncontrolled eye pressure. Some studies of the Cyclo G6 have shown a 30-40% reduction in intraocular pressure (IOP) so this is a very promising therapy for our patients. In addition, the ability to reduce IOP without incisions nor using implants in a quick procedure is very attractive, as is the repeatability, potentially extending the time before more invasive measures are required,” Dr. Keith Barton of London’s Moorfields Eye Hospital said in prepared remarks.
The unit will be commercialized with 2 disposable probes, including the company’s MicroPulse P3 probe and the G-Probe, and Iridex said it plans to introduce a series of additional new probes over the coming year.
“We are thrilled to receive CE Mark approval for the Cyclo G6 System in Europe and welcome this significant step forward in making this system available to patients on a global scale. The Cyclo G6 is a new and effective option for those patients who have been unsuccessful with the burden of frequent administration of eye drops and do not wish to have surgical intervention or implants. Underscoring that point, a recently published study of surgical implant patients found that the decision to implant the device was based on the wish of the patient to reduce or possibly eliminate the burden of topical glaucoma medications – we feel that the MicroPulse solution provides that ability, while precluding or delaying the need for surgical implants,” CEO Will Moore said in a press release.