PART of News Release
FDA Takes Positive Action as Visudyne Review Nears Completion
ATLANTA and VANCOUVER, British Columbia, Feb. 11 /CNW/ --
CIBA Vision, the eye care unit of Novartis, and QLT PhotoTherapeutics Inc.
(Nasdaq: QLTI) announced today that the U.S. Food and Drug Administration
(FDA) has issued an approvable letter for Visudyne(TM) (verteporfin for
injection) therapy to treat the wet form of age-related macular degeneration
(AMD), the leading cause of blindness in people over the age of 50 in the
western world. An approvable letter, commonly issued prior to an approval,
indicates the agency intends to approve the application.
In the letter received by QLT and CIBA Vision today the FDA stated that
they have reviewed the application and Visudyne therapy is approvable. The
FDA recognizes that any remaining deficiencies identified in the letter may
have been addressed by recent information provided to the FDA by QLT, but that
material is still under review.
Once the review is completed and the information has been found
satisfactory, the FDA has indicated they will approve Visudyne therapy
specifically for the treatment of AMD in patients with predominantly classic
subfoveal choroidal neovascularization (CNV), the indication sought by CIBA
Vision and QLT.
"We are pleased that there are no major outstanding issues raised in the
FDA's letter or issues requiring additional clinical trials," said Dr. Julia
Levy, President and CEO of QLT. "As always we intend to work closely with the
agency as it completes its review." Dr. Levy added that QLT doesn't expect
any major delays prior to approval.
The FDA recognizes that the wet form of AMD is a serious condition that
robs patients of their central vision and one for which existing treatments
are limited. As such, on August 23, 1999, the Visudyne submission was granted
priority status, which required the agency to respond to the application on or
before February 12, 2000.
"This is a significant milestone," said Luzi von Bidder, President of CIBA
Vision's worldwide Ophthalmics Business Unit. "This letter indicates that
Visudyne therapy will soon provide a much-needed treatment for the many
patients losing their vision to this devastating condition."
Von Bidder added that, in the interim, CIBA Vision will continue to
provide treatment to eligible patients through its ongoing Treatment-
Investigational New Drug (T-IND) program, in which more than 2600 patients in
North America have been treated to date.
|
