Coherent
This article was originally published in The Gray Sheet
Executive Summary
Joint device/drug market application for Visudyne therapy for wet, age-related macular degeneration is assigned priority review status by FDA. The agency will act on the application, filed jointly by Coherent and QLT PhotoTherapeutics, within six months. Coherent expects FDA to convene the Ophthalmic Devices Panel ahead of its next scheduled meeting to review the application. The submission covers Coherent's OPAL 698 nm diode photoactivator laser, and QLT's drug verteporferin. The therapy will be marketed worldwide by Novartis' eye care unit, CIBA Vision