In Brief: Visx' Star
This article was originally published in The Gray Sheet
Executive Summary
Visx' Star: FDA files premarket approval application supplement for use of the excimer laser for treatment of moderate-to-severe myopia between -6 diopters and -12 diopters with up to -4.00 diopters of concomitant myopic astigmatism, the company says. The supplement has been granted expedited review status, Visx notes. The system is currently marketed for treatment of myopia of -1 to -6 diopters with concomitant myopic astigmatism of -0.75 to -0.4 diopters. The laser requires a "simple software change" to be able to treat the patients covered in the new supplement, the firm states. No additional hardware or disposables are required...