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Biotech / Medical : QLT PhotoTherapeutics (QLTI) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (1162)	2/4/2001 12:59:41 PM
From: Ian@SI	Read Replies (2) \| Respond to of 1321

Ed, I found the answer to my question in the Archive of year 2000 news stories. Unless I'm numerically challenged, this means that the FDA will rule by Mar 1st. qlt-pdt.com In part that story is: Visudyne™ Supplemental Filing Granted Priority Review by FDA SUPPLEMENTAL NEW DRUG APPLICATION SUBMITTED TO FDA FOR EYE CONDITIONS BEYOND AGE-RELATED MACULAR DEGENERATION FOR IMMEDIATE RELEASE AUGUST 29, 2000 ATLANTA, GEORGIA and VANCOUVER, CANADA-CIBA Vision Corporation, the eye care unit of Novartis AG (NYSE:NVS), and QLT Inc. (NASDAQ:QLTI; TSE:QLT) today announced that the United States Food and Drug Administration (FDA) has assigned priority review status to the supplemental new drug application (sNDA) for Visudyne™ (verteporfin for injection) therapy filed August 14, 2000. The submission seeks to expand the initial indication to include patients with other ocular conditions characterized by choroidal neovascularization (CNV). These other diseases include pathologic myopia (PM), ocular histoplasmosis syndrome (OHS), angioid streaks, CNV due to certain retinal abnormalities, and idiopathic causes, among others. The priority review status means that the FDA intends to act on the application within six months. "Existing treatment options for patients with pathologic myopia or ocular histoplasmosis are extremely limited," said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmic Business Unit. "Many of these patients are still in the prime of their career and in the midst of raising their families. The FDA priority status is positive news for these patients who risk progressive loss of vision." Visudyne has already been approved for commercial use in age-related macular degeneration (AMD) patients with predominantly classic choroidal neovascularization (CNV) in 22 countries, including the U.S., Canada, European Union, and Australia. CNV is a growth of abnormal blood vessels under the central part of the retina, or macula. These vessels leak fluid and cause scar tissue that destroys central vision, resulting in a deterioration of sight. "This supplemental filing is based primarily on new safety and efficacy findings that were presented at the Association for Research in Vision and Ophthalmology meeting in May 2000," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "The study has recently been submitted for publication in a leading peer-reviewed ophthalmology journal."