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DewDiligence

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Re: DewDiligence post# 998

Friday, 10/15/2004 12:54:23 PM

Friday, October 15, 2004 12:54:23 PM

Post# of 252581
Visudyne disappointment in occult AMD:

[Nearly lost in the fallout from the failure of Alcon’s Retaane vs Visudyne study was disappointing news on Visudyne itself from a trial conducted by QLTI in patients with the occult form of wet AMD. Currently, Visudyne is not approved in the U.S. for occult AMD, but it is reimbursable by CMS for certain subsets of occult disease defined by lesion size and the rate of disease progression (#msg-2244539).

The inability of the QLTI’s VIO trial to meet its primary endpoint at one year does not necessarily doom a Visudyne label expansion into occult AMD because the trial could yet be successful at *two* years (as explained below); however, the failure to meet the primary endpoint at one year substantially decreases the probability of a successful trial outcome and lessens the likelihood that Visudyne will make further commercial inroads into the occult segment of the market.]

http://biz.yahoo.com/prnews/041014/to290_1.html

>>
Visudyne(R) in Occult (VIO) trial to continue to its conclusion at 24 months

VANCOUVER, Oct. 14 /PRNewswire-FirstCall/ - QLT Inc. (NASDAQ: QLTI) announced today that it will continue the Visudyne® (verteporfin for injection) in Occult (VIO) trial to the 24-month endpoint. This announcement is made following an analysis of the 12-month data which included an independent analysis by the Data and Safety Monitoring Committee (DSMC) and their recommendation that the trial should continue unchanged to its conclusion at 24 months.

The VIO trial is an ongoing Phase III, multicenter double-masked randomized trial to determine if photodynamic therapy with Visudyne can reduce the risk of vision loss in age-related macular degeneration (AMD) patients with subfoveal occult with no classic choroidal neovascularization (CNV). The trial was designed to confirm the results of a previous Phase III trial, known as the VIP (Verteporfin In Photodynamic Therapy) trial, in patients with similar lesion type. While some benefit was seen in year one in the VIP trial, the trial did not achieve statistical significance in the primary outcome until year two. Similarly, the VIO trial did not achieve statistical significance at the 12-month time point. However, the VIO trial prospectively designated both 12 and 24 months as primary endpoints, therefore, statistical significance in either time point would be sufficient to conclude that the VIO trial is positive. Assuming the trial is positive, QLT plans to file for regulatory approval in the U.S. when the trial concludes. Visudyne is marketed by Novartis Ophthalmics, a division of Novartis AG.

There were no new safety concerns identified in the VIO trial to date. The DSMC is an independent panel of experts who are not participating in the studies. The primary responsibility of the DSMC is to oversee the studies and safeguard the interests of current and future participants in these trials.
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