In mid-April, the FDA approved Visudyne
(verteporfin) therapy for the treatment of the predominantly classic form of
wet AMD. (See page 6.)
The approval came on the heels of positive
results from a Phase III study conducted by CIBA Vision and QLT
PhotoTherapeutics Inc., which confirmed that the benefits and safety of
Visudyne therapy are sustained over a
2-year period. Of 242 patients in the study who had predominantly classic
choroidal neovascularization (CNV), 59.1% lost less than three lines of vision,
compared to 31.3% of patients administered placebo. The percentage of patients
experiencing improved vision remained stable at 13%.
Also, 1-year results from a separate and
ongoing Phase IIIb study show that Visudyne therapy benefits patients with CNV
due to pathologic myopia.
"We are encouraged with the results in
the pathologic myopic patients," said Dr. Julia Levy, President and Chief
Executive Officer of QLT. "Until now this group of younger patients have
had very little hope once diagnosed with the condition -- a devastating
proposition given that the vast majority of them are still in the workforce. We
intend to discuss this potential new indication with the FDA to determine the
viability of a supplemental new drug application for Visudyne."
A complete analysis of the results is under
way.