FDA To Start Review For STAAR’s Implantable Collamer Lens

STAAR Surgical has been informed by the FDA Division of Bioresearch Monitoring that the restrictions of the integrity hold put in place by the FDA on August 3, 2007 have been removed. The removal of the hold enables the FDA to resume scientific review of the STAAR application for the Toric Implantable Collamer Lens (TICL) for Myopic/Astigmatic patients.

Barry Caldwell, president and chief executive officer of STAAR Surgical, said: We are very pleased by the FDA’s decision to remove the integrity hold. This very important step in the process is not to be construed as approval of any conditions that may be found in the future, nor should it be construed as clearance to market the Visian Toric ICL.

The removal does require that any supplement related to the Visian Toric ICL be audited and contain a certification from an independent third party auditor that all data in submission is complete, accurate and reliable. This same standard will be applied to the next subsequent submission for a 510(k), IDE or PMA sent to the FDA by the company. We believe the outstanding clinical results with this technology are evidenced by the Visian Toric ICL’s data. Additional evidence is the acceptance of the technology as more than 150,000 Visian ICLs have been implanted worldwide, of which more than 27,000 have been Visian Toric ICLs outside the US The Visian Toric ICL corrects both myopia and astigmatism with the same procedure.”