STAAR Surgical Company reported on the status of its application to obtain approval to market Visian ICL products in Japan.
The Ministry of Health, Labour and Welfare’s Expert Meeting II was held at the end of July in Japan, during which the STAAR Visian ICL products were considered for approval in the Japanese market. The Company received a formal written feedback within the anticipated timeline. This feedback includes formal requests for additional information regarding potential labeling and long-term clinical data. STAAR will respond to those requests very quickly and anticipates significant dialogue with PMDA officials during the month of August.
We are very encouraged and pleased with the feedback and guidance we have received from the PMDA on the outcome of the Expert Meeting regarding the Visian ICL products, said Barry G. Caldwell, President and CEO of STAAR Surgical. Our team in Japan will be focused on working with PMDA in the coming weeks as we move to the final phase of approval to market the Visian ICL products. Obtaining the ability to market the Visian ICL products in Japan should create a significant opportunity for the Company in what we believe has emerged as the world’s third largest myopic market.