10-Year Study Demonstrates IRIDEX MicroPulse™ Laser Therapy Safe, Effective for Patients with Diabetic Macular Edema
Results show innovative tissue-sparing laser therapy creates durable therapeutic effect without the damage caused by traditional laser techniques
MOUNTAIN VIEW, Calif., Dec. 12, 2011 /PRNewswire/ -- IRIDEX Corporation (Nasdaq: IRIX) today announced that data from a clinical study(1) compiled over 10 years demonstrates the safety and efficacy of MicroPulse laser therapy for treating diabetic macular edema (DME) without the retina tissue damage associated with conventional laser therapy. According to the United States Centers for Disease Control and Prevention, DME, a swelling of retinal tissue, is the leading cause of new cases of blindness amongst adults aged 20-74 in the US.(2)
The study, which was released via early publication, was led by Jeffrey K. Luttrull , MD, an ophthalmologist and retinal surgeon with the Ventura County Retina Vitreous Medical Group in California. A total of 252 eyes with macular edema (212 eyes due to diabetic retinopathy, 40 eyes due to branch retinal vein occlusion) were followed. Of these, 181 patients met study inclusion criteria, received subvisible MicroPulse laser treatment, and were followed for up to 10 years.
Dr. Luttrull stated, "MicroPulse laser therapy is an ideal first-line treatment for retinal vascular macular edema because of its unique safety profile. Using specific laser parameters discussed in our recent study, MicroPulse laser treatment can be performed which I believe is both absolutely harmless and at least as effective as conventional thermal retinal photocoagulation. Because of its unique ability to produce the desired therapeutic effect without any measurable inflammation or damage to functional retinal tissue, treatment can be initiated earlier, possibly improving long-term outcomes."
Diabetes affects 25.8 million people, or 8.3% of the US population. In 2005-2008, 4.2 million people, or 28.5% of the US population, with diabetes aged 40 years or older had diabetic retinopathy, and of these, 655,000 had advanced diabetic retinopathy.(2)
"The 10-year study is an excellent validation of our work toward creating a new durable therapy for eye conditions associated with diabetes," said Dominik Beck , PhD., IRIDEX President and CEO. "Our goal is to create a paradigm shift in the way physicians treat retinal diseases. Considering the durable clinical benefits, the safety of the procedure and the economic benefits to the healthcare system, leading physicians are beginning to conclude that MicroPulse can be used earlier in the disease progression and can be, at least, incorporated into any treatment regimen – either alone or in conjunction with drug therapy."
(1) Luttrull JK, Sramek C, Palanker D, Spink CJ, Musch DC. Long-term safety, high-resolution imaging, and tissue temperature modeling of subvisible diode micropulse photocoagulation for retinovascular macular edema. Retina 2011; Publish Ahead of Print:10.1097/IAE.0b013e3182206f6c
(2) Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011
About MicroPulse Technology
MicroPulse is a tissue-sparing laser 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.
IRIDEX Corporation was founded in 1989 and is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems and delivery devices. We provide solutions for multiple specialties, including ophthalmology, dermatology and otolaryngology. 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 100 independent distributors into 107 countries. For further information, visit the Company's website at http://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, relating to the Company's strategic plans with respect to MicroPulse technology and new treatments relating thereto. 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 1, 2011 and our Quarterly Reports on Form 10-Q for the fiscal quarters ended April 2, 2011, July 2, 2011 and October 1, 2011, each of 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.
SOURCE IRIDEX Corporation
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