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Challenges of
Commercialization of PDT - the Visudyne Example
Levy, Julia1
QLT Phototherapeutics Inc.1
Abstract-
We have had the opportunity with Visudyne to take a photosensitizer
from the stages of its original synthesis, evaluation and preclinical
testing through all the stages of drug development to eventually participate
in the commercialization of this product. Visudyne (verteporfin), also
referred to as BPD-MA in earlier publications, was chosen as a potentially
useful photosensitizer because of its intrinsic properties: long maximum
wavelength of activation, relative ease of formulation even though it
was a hydrophobic drug, relative simplicity of synthesis, its high potency
of photoactivation, and its somewhat unusual pharmacokinetic properties.
Although it was originally developed for testing and use in the treatment
of cancer, and was tested initially in the treatment of skin lesions,
in the early 1990's its possible applications in the treatment
of age related macular degeneration (AMD) was evaluated. Our decision
to pursue this indication as opposed to the treatment of cancer was
driven by both the opportunity and our market research, which indicated
a large unmet need for a new approach to treating AMD. Clinical trials
initiated in late 1995 established quite quickly that PDT in treating
neovasculature in the eye had a lot of promise. From the time of the
treatment of the first patient with AMD in 1995 to the point of our
first regulatory approval was slightly less than five years. This underlined
the clinical need for this therapy. Visudyne realized $150 million US
of sales during its first year, making it the most successful ophthalmic
product ever launched.
Keywords: AMD,
Visudyne
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