MONROVIA, Calif., July 31 /PRNewswire-FirstCall/ -- STAAR Surgical Company , a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced it has received approval from the State Food and Drug Administration of the People’s Republic of China (SFDA) to market the STAAR Visian(TM) ICL (Implantable Collamer Lens) to ophthalmologists and other eye care professionals in the country.
“This approval is an important achievement for STAAR,” said David Bailey, President and CEO of STAAR Surgical. “It will allow us to enter a market that we believe has the potential to become one of the largest markets for the Visian ICL. Currently, China is the second largest market in the world for the LASIK procedure and there is a higher rate of incidence for myopia and astigmatism in Asian countries compared with the rest of the world. With these two market dynamics, we believe that successful entry into this market could lead to meaningful growth in our overall refractive business.
“We have already established a training center, as well as a regional distribution operation in China,” Mr. Bailey added. “A proctor has been hired and we expect to begin procedures in August. We also continue to pursue approval from the SFDA for the Visian(TM) Toric ICL and are hopeful that we will receive approval by the end of the current year,” he concluded.
“The Visian ICL provides a very safe choice for correcting myopia,” said Prof. Shen Ye of the Zheyi Eye Center in Hangzhou, China. “The SFDA’s approval is an important milestone for the correction of myopia in our country. The ICL allows the patients the opportunity to acquire excellent natural vision. Our Clinic research indicates that the ICL has very high patient satisfaction levels,” he concluded.
Made of STAAR’s proprietary, highly biocompatible Collamer(R) material, the ICL is the only minimally invasive foldable lens of its kind approved for the Chinese commercial market. As a result of the unique foldable design, the ICL procedure allows an incision up to 50% smaller than competing technology, and its placement in the eye behind the iris provides a more aesthetically pleasing outcome.
Myopia, which is the inability to see distant objects as clearly as near objects, and astigmatism, which is an uneven curvature of the surface of the eye that causes visual blurriness, occur more frequently in Asian countries. In May 2005, STAAR announced it had received approval to market the Visian Toric ICL in South Korea and the ICL and Toric ICL in Singapore. South Korea is currently the Company’s largest Asian market for the Visian ICL and TICL and one of the Company’s top two markets internationally.
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 are used by ophthalmic surgeons and 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. STAAR’s ICL is approved by the FDA for use in treating myopia, has received CE Marking and is approved for sale in 43 countries. More than 50,000 ICLs have been sold worldwide. Collamer(R) is a registered trademark for STAAR’s proprietary collagen co-polymer lens material. More information is available at http://www.staar.com.
Safe Harbor
All statements in this press release that are not statements of historical fact are forward-looking statements, including any statements of the plans, strategies, and objectives of management for future operations, any statements regarding expectations for success of the ICL or other products in U.S. or international markets, 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, our ability to overcome negative publicity resulting from warning letters and other correspondence from the FDA Office of Compliance, the willingness of surgeons and patients to adopt a new product and procedure, and our ability to successfully launch and market the ICL in the U.S. while overcoming the foregoing challenges. Our ability to capitalize on the opportunity presented by the U.S. ICL approval depends on our overall financial condition, which can be adversely affected by general economic conditions and other factors beyond our control, including those detailed from time to time in our reports filed with the Securities and Exchange Commission. STAAR assumes no obligation to update these 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, 646-277-8706 Jenifer Kirtland, 415-896-6820
STAAR Surgical Company
CONTACT: Investors: Douglas Sherk, +1-415-896-6820, or Jenifer Kirtland,+1-415-896-6820; or Media: Steve DiMattia, +1-646-277-8706, all of EVCGroup
Web site: http://www.staar.com/
