Japan grants STAAR Surgical approval to market phakic lens

Monrovia, CA

-The Japanese Ministry of Health, Labor and Welfare (MHLW) has given regulatory approval for STAAR Surgical Co. to market its implantable contact lens (Visian Implantable Collamer Lens) in that country for the treatment of myopia.

Barry G. Caldwell, president and chief executive officer of STAAR Surgical, called the approval “a major milestone” for the company.

“Japan is currently the third largest refractive market and offers an opportunity for additional growth,” he said, noting the higher incidence of myopia in the Japanese population compared with other populations.

STAAR Japan is executing the launch plan, anticipates offering certification courses for the lens beginning this month, and expects to begin generating revenue from the product line in the first half of this year, according to David Bailey, president of international operations at STAAR. He added that the company has been working with regulatory agencies for several years.

STAAR now intends to file a partial change application for approval of its toric implantable contact lens in Japan as soon as practicable following discussions with the country’s Pharmaceuticals and Medical Device Agency. MHLW generally requires up to 1 year to process a partial change application fully, although that timeline can change based on the nature of the product under review.