QLT verteporfin Phase III macular degeneration trial completing accrual; firm will file fast-track NDA.
Executive Summary
QLT PHOTOTHERAPEUTICS PLANS VERTEPORFIN FILING FOR FAST-TRACK APPROVAL of the benzoporphyrin derivative for macular degeneration in mid-1999, as Phase III studies near completion. "The company will do a one-year follow-up on those patients with three-month return visits" and then prepare an NDA around October 1998, QLT Phototherapeutics CEO Julia Levy, PhD, told the Medical Investments Northwest conference in Seattle Aug. 18. FDA has indicated that it will grant a six-month priority review.