QLT/Novartis Visudyne

Verteporfin sNDA approval expected by late April, QLT says, following submission of 24-month visual acuity data from Phase IIIb trial in pathologic myopia patients and Phase II data on ocular histoplasmosis syndrome. The submission responds to issues raised in Feb. 2 "approvable" letter from FDA. User fee date for the supplemental NDA pushed back to July 30, but QLT expects FDA action before then. Supplemental NDA, submitted Aug. 14, 2000, is for classic subfoveal choroidal neovascularization caused by pathologic myopia and ocular histoplasmosis syndrome