FDA delays Staar toric submission
This article was originally published in The Gray Sheet
Executive Summary
Agency asks Staar Surgical to amend its PMA supplement application for the Visian TICL (toric implantable Collamer lens), a refractive phakic implant placed in the posterior chamber of the eye to treat nearsightedness and astigmatism, firm says Nov. 27. In a Nov. 20 letter, FDA requests more information and analysis of clinical data, which Staar says could extend the review period by up to six months. The original application, which included clinical data from a trial of 125 primary eyes with one-year follow up was submitted April 28 as a supplement to Myopic Visian ICL, approved in December 2005 for correction of myopia...