FDA removes integrity hold on STAAR Surgical application

STAAR Surgical has received notification from the U.S. Food and Drug Administration that an integrity hold has been removed from the company's application for approval of a toric implantable Collamer lens for myopia and astigmatism.

According to a release from STAAR announcing the FDA's decision, removal of the hold allows the FDA to renew its review of the application that was originally submitted as a premarket supplement to the Visian ICL, which was approved by the FDA in December 2005.

STAAR received notification of the integrity hold in August 2007, and was required to perform an independent audit of all data used in the application, clinical sites involved in data collection, as well as a systems audit of the company. Based on two audit reports assembled by Promedica International (PMI), STAAR submitted a correction action plan to the FDA in May "to address the findings included in the PMI audit reports and provide assurance that all future studies would be conducted in accordance with applicable laws, regulations and good clinical practice," the company said in a release.

"We appreciate the guidance from PMI and the FDA in our efforts to identify and correct any actions or process that help assure the integrity of all clinical data collected by the company," Barry G. Caldwell, president and CEO of STAAR Surgical, said in the release.