FINALLY! GREAT NEWS!!!!!!!! 3507 DJ 12-Apr-00 at 19:10:00 19:39
DJ QLT, Novartis Unit Get FDA OK For Visudyne Eye Treatment
Symbol: QLTI C/QLT I/NOV
Industry: DRG
Government: FDA
Subject: DJN DJWI SCN WEI
Market Sector: NCY NND
Geographic Region: BRC CN EU NME SZ US WEU
Product/Service: DCA DEE DPH
By Otesa Middleton
WASHINGTON (Dow Jones)--A light-activated drug for treating the top cause
of
blindness in older Americans won federal approval Wednesday.
The Food and Drug Administration approved Visudyne, an intravenous drug
from
QLT PhotoTherapeutics Inc. (QLTI), and Novartis AG's (Z.NOV) CIBA Vision,
for
treating severe cases of the wet form of age-related macular degeneration.
The
FDA's move was expected because agency advisers recommended approval of the
drug at a hearing in November.
As the disease, which causes scars on healthy retina tissue, progresses,
sufferers are left with only peripheral vision and a hole in the center of
images.
Visudyne is taken intravenously and isn't activated until a light is shone
into the eye for one minute and 30 seconds. Then the drug seeks out the
abnormal blood vessels.
Dr. Neil Bressler, a Johns Hopkins University ophthalmology professor, led
the clinical trials of Visudyne.
About 30% of the 200,000 people who develop the disease yearly will be
candidates for treatment with Visudyne, Bressler said.
"It won't help people who already lost their vision," he said.
In the studies, two-thirds of patients who were given an inactive placebo
had significant vision loss in a year. Half as many suffered significant
vision loss when treated with Visudyne, Bressler said.
The cause of the disease isn't known, but Bressler said it attacks about
10%
of everyone over age 65.
When Bressler presented the data at the FDA panel in November, the
agency's
advisers said the drug should be approved because there are few treatment
options available. Patients on the drug still lost vision, but at a slower
rate.
Less than 10% of people with the disease are eligible for laser treatment
to
remove damaged tissue if the problem area is small. If the damaged area is
too
big, laser isn't an option because the laser would do more damage to the
patient's sight, Bressler said.
Analysts at CIBC World Markets Corp. expect sales of Visudyne to be $90
million this year, growing to $335 million next year, $476 million in 2002
and
reaching $613 million in 2003.
-Otesa Middleton; Dow Jones Newswires; 202-862-6654
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