Extra review delays lens approval

Monrovia, CA-STAAR Surgical Co. says the application for its toric phakic implantable IOL (Visian TICL) will be submitted to the Ophthalmic Devices Panel of the FDA's Center for Devices and Radiological Health for evaluation, delaying the approval it had hoped would come later this year.

The company said its application is receiving this unusual step because the lens is the first toric phakic implantable lens to be reviewed. It would potentially treat myopia and astigmatism in adults.

The company submitted its application for the lens to the FDA on April 28, 2006, as a supplement to the pre-market approval application for another lens (Visian ICL). The latter lens was approved in December 2005 for the correction of myopia in adults and is available for sale in the United States.

The supplemental filing requests permission to market the toric lens to correct myopia and astigmatism in adults with myopia ranging from –3 D to less than or equal to –20 D with astigmatism ranging from 1 to 4 D at the spectacle plane, with anterior chamber depth 3 mm or greater and a stable refractive history within 0.5 D for 1 year prior to implantation.

STAAR said its representatives met Jan. 31 with staff from the FDA's Office of Device Evaluation to discuss the company's supplemental premarket approval application for the toric lens. The company said it no longer anticipates approval in 2007.

"It is highly unusual for a supplemental application to be submitted to the panel for review," said David Bailey, STAAR Surgical's president and chief executive officer. "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."