Visx' excimer laser gets approvable recommendation
This article was originally published in Clinica
Executive Summary
Visx' (US) excimer laser system for photorefractive keratectomy received a conditional approval recommendation from the US FDA's ophthalmic devices advisory panel on October 20th. Panel members criticised the company for having incomplete patient follow-up and said they would not recommend approval until two-year follow-up included 90-95% of patients. Visx is seeking marketing approval for use of the laser in patients 18 years and older with -1.0 to -6.0 dioptre myopia with a best corrected vision of at least 20/40.