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STAAR Surgical Reports Progress on Japan Application for Approval of Visian Toric Implantable Collamer® Lens (TICL)
Date:10/19/2011

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 ra
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SOURCE STAAR Surgical Company
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