MONROVIA, Calif., Aug. 20 STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today reported on the status of its application to obtain approval to market the Company's Visian ICL products in Japan.
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As anticipated, the Ministry of Health, Labour and Welfare's Expert Meeting II was held at the end of July in Japan, at which time the STAAR Visian ICL products were considered for approval in the Japanese market. The Company has received formal written feedback within the anticipated timeline. This feedback includes formal requests for additional information regarding potential labeling and long-term clinical data. STAAR will respond to those requests very quickly and anticipates significant dialogue with PMDA officials during the month of August.
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"We are very encouraged and pleased with the feedback and guidance we have received from the PMDA on the outcome of the Expert Meeting regarding the Visian ICL products," said Barry G. Caldwell, President and CEO of STAAR Surgical. "Our team in Japan will be focused on working with PMDA in the coming weeks as we move to the final phase of approval to market the Visian ICL products. Obtaining the ability to market the Visian ICL products in Japan should create a significant opportunity for the Company in what we believe has emerged as the world's third largest myopic market."
"Estimates are that over 400,000 refractive procedures will be performed in Japan during 2009," continued Mr. Caldwell. "The Japanese population is believed to have one of the highest prevalence rates of myopia in the world as well as a much higher percentage of the population in the high myopic range. Market Scope, the industry leading ophthalmic research firm, reports that the worldwide average rate of myopia is 23% of the population, while the rate in Japan is 45%. This compares to an estimated 27% prevalence rate of myopia in the U.S. The Tajimi Study which evaluated the prevalence of myopia in Japan reported that the percentage of moderate and high myopes in the pool of myopes is very high in Japan. In fact, the prevalence rate of myopia climbs to 70% for those Japanese who are in the age group of 40 to 49. Additionally, 15% of that age group suffers from high myopia which is also a much higher rate than other parts of the world. Currently over 70% of the refractive procedures in Japan are performed in a laser centers and the Visian ICL should allow more ophthalmologists to participate in this growing refractive market. Thus, a very favorable market environment should await the Visian ICL, and with our own sales and distribution organization in place in Japan, we are well positioned to meet the market's needs," added Mr. Caldwell.
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. Collamer(R) is the brand name for STAAR's proprietary collagen copolymer lens material. More information is available at www.staar.com.
Safe Harbor
All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: prospects for approval to market the Visian ICL and Visian Toric ICL in Japan, or any other future approval by regulatory agencies; the possibility of favorable or adverse agency actions in the future; estimates of future sales of any product or any other financial items; the plans, 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 the broad discretion of the PMDA in approving any medical device and the inherent uncertainty that new devices will be approved, the possibility that PMDA approval of ICL or TICL, if granted, may be subject to significant limitations or conditions, 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 defending pending litigation and satisfying judgment in the event of an adverse ruling, 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 risk that sales of our newly introduced products may not restore profitability to our U.S. IOL product line, our ability to overcome negative publicity resulting from warning letters and other correspondence from the FDA Office of Compliance and to demonstrate to the agency that its past concerns have been resolved, 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 in the U.S. 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 Douglas Sherk, 415-896-6820 Steve DiMattia, 646-201-5445 Mike Pollock, 415-896-5862
SOURCE STAAR Surgical Company
