MAR 17, 2014
STAAR Surgical Company
Refractive Mgmt/Intervention
The Ophthalmic Devices Panel of the U.S. Food and Drug Administration recommended for approval the Visian toric implantable Collamer lens (ICL), but with reservations about the quality of the data collected.
The lens from Staar Surgical is intended for patients between the ages of 21 and 45 with myopia ranging from -3 D to -20 D and 1 D to 4 D of astigmatism.
A majority of the panel ruled in favor of recommending the lens on all three questions before them: 5 to 1, with 3 abstentions that the TICL is safe, 7 to 1 with 1 abstention that it is effective and 6 to 3 that the benefits outweigh the risk of using the lens as indicated. Panel members reportedly described the data collection as “flawed” and “sloppy.”
About 450,000 ICLs have been implanted globally, of which some 120,000 were toric. In the 60 markets in which both the toric and standard myopic lenses are available, 40 percent are toric ICL. Staar also plans a post-approval study to further demonstrate the safety and efficacy of the lens.