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

tes 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 employee
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SOURCE STAAR Surgical Company
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