UK's National Health System Rejects Drug Therapy for Diabetic Macular Edema
Ruling Advances Opportunity for IRIDEX' Tissue Sparing MicroPulse ™ Laser Therapy
MOUNTAIN VIEW, Calif., Dec. 13, 2011 /PRNewswire/ -- IRIDEX Corporation (Nasdaq: IRIX) announced today that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has issued a final guidance which determined that Novartis AG's drug Lucentis is not as cost effective as conventional laser photocoagulation treatment and rejected the leading drug therapy as a treatment for diabetic macular edema (DME), a swelling of retinal tissue and the most common cause of vision loss in diabetics. The rejection means that the UK National Health Service (NHS) currently will not pay for drug therapy with Lucentis for DME treatment in diabetic patients, thereby creating another important opportunity for advanced laser treatments such as IRIDEX' MicroPulse laser therapy, which has shown to be as effective as conventional laser photocoagulation with no associated retina tissue damage.
NICE, an independent appraisal committee which the UK NHS relies upon, determined that the benefits derived by Lucentis do not justify its cost; and that laser photocoagulation represented better value for NHS resources. "While Novartis is certain to appeal the ruling, this is an important indication that DME patients should consider other options besides drug therapy," noted Dominik Beck, PhD., IRIDEX President and CEO.
"This is a very clear and important statement by one of the most important medical care payers in the world: drugs are not a panacea for retinal diseases," Dr. Beck said. "Drugs like Lucentis certainly have a role in ophthalmology and can be an excellent and safe treatment for acute DME, but in addition to high costs, they come with side effects and questions about their long term benefits. That's among the reasons why we now offer MicroPulse technology on all of our new laser systems and why MicroPulse technology should be considered a first line treatment for most forms of DME. Numerous recent studies show that MicroPulse technology can provide significant durable benefits for diabetes patients without damaging the retina; thus providing powerful economic advantages for both the payors and patients."
DME is a rapidly expanding retinal disorder. Up to 10% of all diabetics will develop DME during their lifetime. Detecting and treating diabetic eye disease with laser therapy can reduce the development of severe vision loss by an estimated 50% to 60%.
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.
About IRIDEX Corporation
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 opportunities for advanced laser treatments, the Company's MicroPulse technology, the economic and therapeutic benefits of this technology and the Company's growth strategy. 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 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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