MONROVIA, Calif., Oct. 19, 2011 /PRNewswire/ -- STAAR Surgical Company (Nasdaq: STAA), the leading developer, manufacturer and marketer of minimally invasive refractive lenses, today announced that it has received notice from the PMDA (Pharmaceuticals and Medical Device Agency) in Japan that the Company's Toric ICL application will not need to go before the Approval Committee. In addition the PMDA and Japan's MHLW (Ministry of Health, Labour and Welfare) have permitted STAAR to add the clinical data collection on the Toric ICL Post Market Studies (PMS) to the current PMS protocols underway for the Visian ICL.
"This is an extremely exciting development for STAAR because it brings us much closer to final approval of our Toric ICL in Japan," said Don Todd, President of the Asia Pacific Region. "Some additional steps remain in the approval process, but we are optimistic that these can be completed fairly quickly. The rates of myopia and astigmatism in Japan are quite high relative to other parts of the world, and we believe our Toric ICL offers a superior solution to many potential patients in Japan."
According to Market Scope, 2010 Comprehensive Report on The Global Refractive Surgery Market, Japan is the third largest market in the world with 375,000 procedures performed in 2010. In Japan, approximately 30% of the population had some degree of astigmatism according to their data. Only 445 of the 11,200 ophthalmologists in Japan perform laser refractive surgery. The Visian ICL allows the current cataract surgeon in Japan to participate in the refractive market with a procedure that does not require an investment in capital equipment.
The Tajimi Study, published in 2007, was a random sampling of over 3,000 residents of Tajimi, Japan. The study indicated an overall rate of myopia of 41.8%, significantly higher than all other published rates of myopia worldwide. This rate expands to 70% for those 40 to 49 years of age with 15% of the population suffering from a high degree of myopia. The study also found that 54% of its population had some degree of astigmatism, with 26% suffering from a very high degree of astigmatism.
Final regulatory approval in Japan will require that the DFU (Directions for Use) be finalized, the Post Market Study protocol for the Toric ICL be completed, and the GCP (Good Clinical Practices) audit of the U.S. clinical trial data be finalized. STAAR submitted the GCP audit responses to regulators on October 17, 2011 and a meeting was held earlier today in Japan. The Company would expect to have all these requirements completed within the next few months.
"With the high rate of myopia and astigmatism in Japan, the approval of the Toric ICL will offer a significant opportunity for STAAR," said Barry G. Caldwell, President and CEO. "We will continue to work closely with the PMDA to complete the steps necessary for approval. Over a quarter of a million ICLs have been implanted globally. Once the Toric ICL is approved in Japan, the U.S. will be the only major market in the world where the Toric ICL is not approved."
About STAAR SurgicalSTAAR, which has been dedicated solely to ophthalmic surgery for over 25 years, designs, develops, manufactures and markets implantable lenses for the eye. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. A lens used to replace the natural lens after cataract surgery is called an intraocular lens or "IOL." A lens used in refractive surgery as an alternative to LASIK is called an Implantable Collamer® Lens or "ICL." Over 250,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: www.visianinfo.com. STAAR has approximately 300 full-time employees and markets lenses in approximately 50 countries. Headquartered in Monrovia, CA, it manufactures in the following locations: Nidau, Switzerland; Ichikawa City, Japan; Aliso Viejo, CA; and Monrovia, CA. For more information, please visit the Company's website at www.staar.com or call 626-303-7902.
Collamer® is the registered trademark for STAAR's proprietary biocompatible collagen copolymer lens material.
Safe HarborAll statements in this press release that are not statements of historical fact are forward-looking statements, including any statements about the approval of pending regulatory applications, the potential effect of new product approvals on our business, any 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 following: the effect of poor global economic conditions on sales, especially sales of products like the ICL used in non-reimbursed elective procedures; our limited resources to promote new products; the discretion of regulatory agencies to approve or reject new products, or to require additional actions before approval, the risk that product launches may be affected by unplanned delays or be less successful than we expect; the willingness of surgeons and patients to adopt a new product and procedure; the entrenched market position of laser-based procedures for many conditions treated by the Visian ICL; and patterns of Visian ICL use that have typically limited our penetration of the refractive surgery market. 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:
EVC GroupJenifer Kirtland/Doug Sherk
Christopher Gale 415-568-9349
|SOURCE STAAR Surgical Company|
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