STAAR Surgical reports progress on application to market products in Japan

September 2, 2009

STAAR Surgical Co. President and Chief Executive Officer Barry G. Caldwell said he is “encouraged and pleased” with feedback the company has received from the Japanese government regarding the possibility of marketing its implantable contact lens ([ICL] Visian Implantable Collamer Lens) products there.

Monrovia, CA —STAAR Surgical Co. President and Chief Executive Officer Barry G. Caldwell said he is “encouraged and pleased” with feedback the company has received from the Japanese government regarding the possibility of marketing its implantable contact lens ([ICL] Visian Implantable Collamer Lens) products there.

After a meeting of the country’s Ministry of Health, Labour, and Welfare in July, the company received written feedback that included formal requests for additional information regarding potential labeling and long-term clinical data, according to a statement issued by STAAR Surgical.

“Our team in Japan will be focused on working with [Japan’s] Pharmaceuticals and Medical Devices Agency in the coming weeks as we move to the final phase of approval to market the . . . ICL products,” Caldwell said.

The ability to market ICL products in Japan should create a significant opportunity, he said, because Japan is now the world’s “third-largest myopic market,” with more than 400,000 refractive procedures expected to be performed in 2009.

“Market Scope, the industry leading ophthalmic research firm, reports that the worldwide average rate of myopia is 23% of the population, while the rate in Japan is 45%. This compares to an estimated 27% prevalence rate of myopia in the United States,” Caldwell added.

Other research shows that “the prevalence rate of myopia climbs to 70% for those Japanese who are in the age group of 40 to 49. Additionally, 15% of that age group suffers from high myopia, which is also a much higher rate than other parts of the world,” he said.