IRIDEX Announces Cyclo G6™ with MicroPulse® P3 Clinical Data Presented at ARVO and ASCRS Annual Meetings
Data underscore safety and efficacy of non-invasive tissue-sparing technology in patients with glaucoma
MOUNTAIN VIEW, Calif., May 10, 2016 /PRNewswire/ -- IRIDEX Corporation (Nasdaq: IRIX), a leading global provider of innovative laser systems, delivery devices and consumables in ophthalmology, today announced that data on its MicroPulse® P3 device powered by the Cyclo G6™ Glaucoma Laser System was presented at both the Association for Research in Vision and Ophthalmology (ARVO) 2016 Annual Meeting from May 1-5 in Seattle and the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting 2016 from May 6-10 in New Orleans.
The presentation by Robert J. Noecker, M.D., M.B.A., at ARVO titled, "MicroPulse trans-scleral cyclophotocoagulation for the treatment of glaucoma" evaluated the safety and efficacy of IRIDEX's Cyclo G6 system using the MicroPulse P3 probe in a cohort of glaucoma patients. The data showed significant mean intraocular pressure (IOP) reduction in the patient population as well as the ability to safely retreat patients, if necessary to achieve the target pressure.
"The outcomes of this study highlight the power of MicroPulse technology to effectively and non-invasively reduce intraocular pressure, the modifiable risk factor in treating glaucoma," said Dr. Noecker. "These data also demonstrate the unique ability of the technology to be safely used in patients who may require re-treatments to successfully lower IOP. I am encouraged by the results and believe they underscore the potential of this technology to be an important part of our arsenal in addressing the growing glaucoma problem."
A study population of 45 glaucoma patients (45 eyes) with a mean pre-operative intraocular pressure (IOP) of 28.1 mmHg were subject to micropulse trans-scleral cyclophotocoagulation with the MicroPulse P3 probe at 2.0 watts, with a total duration of 140-180 seconds at a 31.3% duty cycle. Results showed that there was a mean IOP reduction among the study population of 42% (an average of 16.4 mmHg). Ten of the 45 patients needed re-treatment with the Cyclo G6 to achieve the target IOP, and all of these patients responded to repeat treatment with MicroPulse.
These data were also presented by Dr. Noecker in a session titled, "The lighter side of cyclodestruction: MP3CPC and ECP" at the ASCRS Annual Meeting 2016 during the Glaucoma Day sessions on May 6th.
"Dr. Noecker is among the thought leaders in ophthalmology coming to the conclusion, based on a growing body of data and sound economics, that MicroPulse technology will play an important role in the battle against the global glaucoma epidemic," said Will Moore, President and CEO of IRIDEX. "The ability to treat patients at different stages of the disease and to repeat treatments over time as necessary to control IOP, without invasive implants or surgery, is an important option that delivers benefits to the patient, provider and payor communities."
About MicroPulse Technology
MicroPulse is a tissue-sparing laser delivery therapy that works by electronically "chopping" the laser emission into trains of microsecond pulses. This enhances the physician's ability to more precisely control the laser effects on target tissues, offering the potential for ocular treatment with less collateral effects than conventional laser treatments.
About IRIDEX
IRIDEX Corporation was founded in 1989 and is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology market. We maintain a deep commitment to the success of our customers, with comprehensive technical, clinical, and service support programs. IRIDEX is dedicated to a standard of excellence, offering superior technology for superior results. IRIDEX products are sold in the United States through a direct sales force and internationally through a combination of a direct sales force and a network of approximately 70 independent distributors into over 100 countries. For further information, visit the IRIDEX website at www.iridex.com.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, including those statements concerning the Company's products, including the Cyclo G6™ Glaucoma Laser System and MicroPulse® technology, future demand and order levels for the Company's products, the adoption and effect of Company products on its results, the markets in which the Company operates, the safety, usage and efficacy of the Company's products, and the Company's strategic plans and objectives. These statements are not guarantees of future performance and actual results may differ materially from those described in these forward-looking statements as a result of a number of factors. Please see a detailed description of these and other risks contained in our Annual Report on Form 10-K for the fiscal year ended January 2, 2016, which was filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and will not be updated.
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SOURCE IRIDEX Corporation
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