In Brief: Visx
This article was originally published in The Gray Sheet
Executive Summary
Visx: Firm gains FDA approval of a premarket approval application supplement for use of its Star excimer laser in correcting myopic astigmatism of -0.75 to -0.4 diopters in patients with myopia of between -1 and -6 diopters. In January, the agency's Ophthalmic Devices Panel recommended that FDA approve the indication. The Santa Clara, California-based firm received an approvable letter in February ("The Gray Sheet" Feb. 17, In Brief). Per the panel's recommendation, the age limit for the new indication is raised from 18 and over to those 21 and over...