<font color=red>► QLTI and the Occult
For Immediate Release February 7, 2001
ATLANTA, GA and VANCOUVER, CANADA--Novartis Ophthalmics, the eye health
unit of Novartis AG (NYSE:NVS), and QLT Inc. (NASDAQ:QLTI; TSE:QLT) today
announced top-line results that showed Visudyne(TM) therapy reduces the
risk of vision loss in a new population of patients with wet age-related
macular degeneration (AMD).
Study Details - Overall AMD Population:
The following results are based on 339 AMD patients treated at 28 centers
throughout North America and Europe over a period of 24 months.
Twelve-month results were announced in March 2000.
"Results from this new study are extremely important because they
demonstrate that Visudyne therapy can reduce the risk of moderate to severe
vision loss in a large number of patients each year for whom, previously,
there was no proven treatment," said Dr. Neil Bressler, retinal specialist
and Chair of the Visudyne Study Advisory Group. Dr. Bressler is also the
James P. Gills Professor of Ophthalmology at the Wilmer Eye Institute of
the Johns Hopkins University School of Medicine in Baltimore, Maryland.
"These results represent a significant milestone in our efforts to expand
the use of Visudyne so that most patients with wet AMD can one day benefit
from Visudyne therapy," said Dr. Julia Levy, President and Chief Executive
Officer of QLT. "We plan to consult with regulatory authorities to
determine how best to proceed from a regulatory and clinical standpoint."
The entire population included mainly patients with occult CNV without
classic components, plus some patients with a component of classic CNV and
with vision better than 20/40. At the 24-month examination, 46% of those
patients treated with Visudyne therapy lost less than 3 lines of vision, or
15 letters, on a standard eye chart (moderate vision loss) compared to 33%
of patients on placebo (p=0.023). The difference of 13% between the treated
and placebo group is statistically significant and higher than the 4%
difference (p=0.51) seen at 12 months. With respect to severe vision loss,
70% of Visudyne treated patients lost less than 6 lines of vision, or 30
letters, on a standard eye chart versus 53% of patients on placebo, a
difference of 17% (p=0.001). Again, this result is higher than the 8%
difference (p=0.14) seen at 12 months. At the 24-month time point,
Visudyne also showed statistically significant outcomes for other visual
acuity endpoints. |
