Visx Gains Panel Nod For Star S2 Hyperopia PRK Indication
This article was originally published in The Gray Sheet
Executive Summary
Labeling for Visx' Star S2 excimer laser for treatment of hyperopia (far-sightedness) with astigmatism using photorefractive keratectomy (PRK) should reflect the lack of data relating to refractive stability in the company's premarket approval application supplement, FDA's Ophthalmic Device Panel recommended at a May 11 meeting in Gaithersburg, Maryland.