Vision Benefit Sustained During Third Year of Visudyne(TM) Therapy
NEW DATA PRESENTED AT INTERNATIONAL OPHTHALMOLOGY CONFERENCE
FOR IMMEDIATE RELEASE MAY 2, 2001
FORT LAUDERDALE, FL--Data presented last night at a symposium held during the annual
Association for Research in Vision and Ophthalmology (ARVO) conference showed that average
visual acuity remained stable during the third year of Visudyne(TM) (verteporfin for injection)
therapy in patients with age-related macular degeneration (AMD), the leading cause of blindness in
people over the age of 50. The research was sponsored by Novartis Ophthalmics, the eye health
unit of Novartis AG (NYSE:NVS) and QLT Inc. (NASDAQ:QLTI; TSE:QLT). Favorable two-year
results were previously published in the February 2001 issue of the Archives of Ophthalmology.
The results are based on an extension of the pivotal Phase III clinical trial called the TAP
(Treatment of AMD in Photodynamic therapy) Investigation, a two-year randomized,
double-masked, placebo-controlled trial. Following the conclusion of the trial, 78% of the original
609 patients in the TAP Investigation were offered Visudyne therapy in an ongoing open-label
extension trial regardless of whether they previously received Visudyne or a placebo in the original
study.
In the extension trial, the average visual acuity of patients originally assigned to Visudyne with
predominantly classic subfoveal choroidal neovascularization caused by AMD (the indication for
which Visudyne is currently approved), remained stable between the 24th and 36th month of
follow-up, while the number of Visudyne treatments required continued to decrease.
During the third year of treatment, patients received an average of 1.4 treatments, a decrease from
the 3.4 and 2.1 treatments received in the first and second year, respectively. Furthermore, the
favorable safety profile previously demonstrated with Visudyne continued throughout the third year.
"It is encouraging that, on average, vision remained stable through the third year of follow-up," said
Dr. Neil Bressler, Chair of the Visudyne Study Advisory Group, and retinal specialist and Professor
of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine
in Baltimore, Maryland. "This finding, coupled with the fact that no additional safety issues arose
from continued treatments, should instill even greater confidence in the long-term benefits of
Visudyne therapy within the medical community."
Detailed findings based on the three-year data will be submitted for publication in a peer-reviewed
medical journal. Yesterday's symposium can be viewed via webcast at
www.visudyne.wwwwebposium.com, using a password that can be obtained from the local Novartis
Ophthalmics office. |
