STAAR'S TORIC IMPLANTABLE LENS SUBJECT TO FURTHER REVIEW BY FDA PANEL

STAAR Surgical has provided an update on the status of the firm's submission to the FDA for approval of its Visian toric implantable Collamer lens (TICL) designed to treat myopia and astigmatism.

In a statement issued Feb. 6, STAAR said its representatives met with CDRH staff Jan. 31 to discuss the agency's comments on the firm's supplemental premarket approval (PMA) application for the TICL. FDA staff indicated that, because the TICL is the first lens of its kind to be reviewed, the firm's amended application for the device would be submitted to the agency's Ophthalmic Devices Panel for evaluation, according to the firm.

It is "highly unusual" for a supplemental application to be reviewed by an FDA panel, STAAR President and CEO David Bailey said. Based on FDA staff feedback, "we believe that approval of the TICL will be unlikely in 2007, as previously anticipated."

STAAR submitted the Visian TICL application in April 2006 as a supplement to the PMA application for its Myopic Visian implantable lens, which the FDA approved in 2005 for correcting myopia in adults.