Research In Brief
This article was originally published in The Gray Sheet
Executive Summary
Staar Surgical: The firm is in discussions with FDA on a protocol for the planned Collamer Accommodating Study Team (CAST) II trial for its nanoFLEX Collamer aspheric single-piece intraocular lens (IOL), CEO Barry Caldwell announced June 9 at the Jefferies Global Life Sciences Conference in Manhattan. The study is designed to determine the "accommodating" properties of nanoFLEX. Early results of the first CAST study suggest nanoFLEX provides superior distance-corrected near vision compared to standard IOLs and comparable results to current premium IOLs (1"The Gray Sheet" Nov. 2, 2009). Following completion of CAST II, the company will undertake CAST III, with a "few minor design changes" to nanoFLEX, to support supplemental PMA approval for a claim of "less spectacle dependence, which would then get us into [the] premium channel," Caldwell said