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QLT announces interim results of radical study evaluating Visudyne combination therapy
Date:12/16/2008 

    Mean visual acuity letter scores increased similarly in all treatment
    groups

VANCOUVER, Dec. 16 /PRNewswire-FirstCall/ - QLT Inc. (NASDAQ: QLTI; TSX: QLT) today announced six-month results from an interim analysis for the Phase II RADICAL study (Reduced Fluence Visudyne Anti-VEGF-Dexamethasone In Combination for AMD Lesions). The RADICAL study is a Phase II, multicenter, randomized, single-masked study comparing reduced-fluence Visudyne(R)-Lucentis(R) combination therapies (with or without dexamethasone) with Lucentis monotherapy in 162 subjects with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The independent Data and Safety Monitoring Committee (DSMC) confirmed that there are no safety concerns at this time and recommended that the trial continue as planned. During this six-month interim period, mean visual acuity (VA) in each group increased from baseline and that increase appears to have been similar between groups. To date, the mean cumulative treatments were lower in the combination groups than in the Lucentis monotherapy group; however, it is too early to draw conclusions about comparative treatment frequencies, because this is influenced by the mandatory retreatments at month 1 and 2 in the Lucentis monotherapy group. The primary endpoint results at 12 months are expected in the first half of 2009.

    In the RADICAL study, subjects were randomly assigned to one of four
treatment groups:

    Group 1: Reduced-fluence Visudyne (300mW/cm2 for 83 seconds to deliver
    25 J/cm2) followed within two hours by intravitreal Lucentis (0.5 mg)
    Group 2: Reduced-fluence Visudyne (300mW/cm2 for 83 seconds to deliver
    25 J/cm2) followed within two hours by intravitreal Lucentis (0.5 mg)
    and then dexamethasone (0.5 mg)
    Group 3: Very low-fluence Vis
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SOURCE  QLT Inc.
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