Ciba Vision Visudyne
Executive Summary
Verteporfin receives "approvable" letter Feb. 11 for an indication to treat the wet form of age-related macular degeneration. FDA is still reviewing information submitted by QLT Therapeutics, which will manufacture the drug, in response to deficiencies cited by the agency. The deficiencies include inadequate description of the manufacturing process and details about international shipping of unstable materials. FDA also noted deficiencies in the premarket approval applications for the low level non-thermal 689 nm light lasers required to activate the drug that are being developed by Coherent and the Carl Zeiss Group. Ciba Vision will market the product worldwide
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