MONROVIA, Calif., Feb. 2 STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, announced today regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the Company's Visian Implantable CollamerŪ Lens (ICL) in Japan.
Japan's MHLW approved marketing the Visian ICL for the treatment of myopia. The Japanese population is believed to suffer one of the highest rates of myopia in the world, with a much higher percentage of the population in the high myopic range than the worldwide norm. Market Scope, the industry leading ophthalmic research firm, reports that the worldwide average prevalence of myopia is 23% of the population, while the prevalence in Japan is 45%. This compares to an estimated 27% prevalence of myopia in the U.S. Over 150,000 Visian ICLs have been implanted worldwide since its introduction.
"Today's announcement represents the achievement of a major milestone for STAAR, and presents us with an opportunity to pursue a very attractive market for the Visian ICL," said Barry G. Caldwell, President and CEO of STAAR Surgical. "The Tajimi Study, which evaluated the prevalence of myopia in Japan, reported that the prevalence of myopia was much higher in Japan than in most other parts of the world. Japan is currently the third largest refractive market and offers an opportunity for additional growth. This also represents the first approval of the Collamer lens material in Japan and hopefully this can lead to future Collamer lens approvals."
"We are very excited to introduce the Visian ICL technology in Japan," added David Bailey, President of International Operations. "Our organization has been working with the regulatory agencies for several years, and this marks the first Phakic lens approval for the Japanese market. With the Visian ICL approval, our team at STAAR Japan is swiftly executing our controlled launch plan to maximize both surgeon adoption and patient satisfaction, and we currently expect to hold our first ICL Certification Course at the end of March and begin generating revenue from the product line during the first half of 2010."
"The Visian ICL is a posterior phakic IOL and has the value not only in safeness due to reversible character, but also in superior visual performance after surgery," said Dr. Kimiya Shimizu, Professor and Chairman of the Department of Ophthalmology at Kitasato University. "Because Visian ICL can be less affected by the healing reaction of the corneal wound which differs in patients, it shows better stability and prediction accuracy compared to LASIK. No expensive laser equipment is necessary and the surgical procedure is easy for experienced cataract surgeons. Among different methods of vision correction, the Visian ICL is the best method theoretically and this product expands its application not only to high myopia but also to medium myopia. This is a new encouraging choice for refractive surgery and I assume that this will be popular widely in the Japanese market."
Having achieved ICL approval, STAAR now intends to file a partial change application for approval of the Visian Toric ICL approval in Japan as soon as practicable following discussions with the Pharmaceuticals and Medical Device Agency(PMDA). MHLW generally requires up to one year to fully process a partial change application, although that timeline can change based on the nature of the product under review.
About STAAR Surgical
STAAR Surgical is a leader in the development, manufacture and marketing of minimally invasive ophthalmic products employing proprietary technologies. STAAR's products include the Visian ICL, a tiny, flexible lens implanted to correct refractive errors, as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. Manufactured in Switzerland by STAAR, the ICL is approved by the FDA for use in treating myopia, has received CE Marking and is sold in more than 50 countries. CollamerŪ is the brand name for STAAR's proprietary collagen copolymer lens material. More information is available at www.staar.com.
All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: estimates of future sales of any product, including the ICL in Japan, or any other financial items; the plans, prospects for approval of the Toric ICL in Japan or other actions by regulators, the strategies and objectives of management for future operations or prospects for achieving such plans; our future performance; statements of belief; and any statements of assumptions underlying any of the foregoing.
These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include our limited capital resources and limited access to financing, the fact that our public accounting firm has expressed doubt about our ability to continue as a going concern in their opinion on our financial statements, the cost of satisfying the recent adverse judgment, for which we have taken no reserve, the effect the global recession in reducing sales of products, especially products such as the ICL used in non-reimbursed elective procedures, the challenge of managing our foreign subsidiaries, the willingness of surgeons and patients to adopt a new product and procedure, and the potential effect of recent negative publicity about LASIK on the demand for refractive surgery in general. Our potential market in Japan may be limited by a number of factors, including the delay in approval of the Toric ICL to treat patients suffering from both astigmatism and myopia. STAAR assumes no obligation to update its forward-looking statements to reflect future events or actual outcomes and does not intend to do so.
CONTACT: Investors Media EVC Group EVC Group Barbara Domingo, 415-896-5862 Chris Gale, 646-201-5431 Douglas Sherk, 415-896-6820
SOURCE STAAR Surgical Company