Toric lens approval unlikely this year, STAAR Surgical says

Monrovia, CA-Approval of its toric phakic implantable lens (Visian TICL) is unlikely to occur in 2007 as formerly anticipated, STAAR Surgical Co. has announced.

The company’s amended application for the lens is now headed for an evaluation by the Ophthalmic Devices Panel of the FDA’s Center for Devices and Radiological Health after a Jan. 31 meeting between company officials and staff of the FDA Office of Device Evaluation.

“It is highly unusual for a supplemental application to be submitted to the panel for review,” said David Bailey, president and chief executive officer of STAAR Surgical. “However, as the [FDA] staff observed, the [lens] is a first-of-its-kind device, and we look forward to providing all necessary support to substantiate its safety and effectiveness. We had hoped for faster review, but based on this feedback, we believe that approval of the [lens] will be unlikely in 2007, as previously anticipated.”

STAAR Surgical submitted its original application for the lens in April 2006 as a supplement to the pre-market approval application for another lens (Visian ICL), which the FDA approved in December 2005 for the correction of myopia in adults and which is now available to patients in the United States. The FDA received the company’s supplement to the pre-market approval application for the toric lens-the subject of the January meeting-in November.

The toric lens is sold for the correction of astigmatism in Europe and some Asian nations.