FEB 2014

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: https://digital.eyeworld.org/i/274531

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Page 83 of 114

"This was an innovative devel- opment and has been a great benefit t o both the patients and the doc- tors," Dr. Shimizu said. "I believe the fact that the lens was officially ap- proved in Asia where the market share accounts for 60% means so much to the international com- pany." In fact, if there were a STAAR Achilles' heel nowadays, it might be t he U.S. market. Have a look at the company's "products" page and it notes several similar issues: "The Visian ICL with CentraFLOW is not available in the United States; The Visian ICL lens that treats hyperopia is not available in the United States; The Visian Toric ICL is not available in the United States." "We doctors living outside the U.S. have doubts about the FDA," Dr. Shimizu said. "I feel that U.S. cit- izens may be those who are missing beneficial [surgical] opportunities the most, in a way." STAAR began selling the Visian ICL outside the United States in 1996 and inside the country in 2006, a full decade later. STAAR received written communication from the FDA on November 22, 2013, indicating the agency's intent to review STAAR's PMA Supplement regarding its Toric ICL at the Ophthalmic Devices Agency Panel meeting scheduled for February 14, 2014. The international vs. U.S. differ- ence is also found in financial re- sults, with the following mentioned in the quarterly report from August 2013: "In the second quarter of 2013, Visian ICLs grew in Europe, Middle East and Africa (EMEA) by 47% in revenue while units in- creased 30% and price 13%; in Asia Pacific (APAC) an increase of 29% in revenue, while units increased 28% and price 1%; in North America (NA) an increase of 9% in revenue, while units increased 13% and price declined 3%. We experienced note- worthy growth in China with a 77% increase in revenue, in France with a 41% increase, in Latin America with a 39% increase, in the Middle East with a 37% increase and in Spain with a 127% increase." It was almost all good news, but the U.S. news paled in comparison to the international. However, this may change when the Visian Toric I CL is approved in the U.S. E W Editors' note: Dr. Shimizu and Ms. Ommerli Weber have financial interests w ith STAAR Surgical. Contact information Shimizu: kimiyas@med.kitasato-u.ac.jp Ommerli Weber: pweber@staarag.ch EW International 81 F ebruary 2014 78-81 International_EW February 2014-DL3_Layout 1 1/31/14 8:25 AM Page 81

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