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QLT announces 12-month results from Novartis sponsored MONT BLANC study evaluating standard-fluence Visudyne(R) combination therapy
Date:6/15/2009

VANCOUVER, June 15 /PRNewswire-FirstCall/ - QLT Inc. (NASDAQ: QLTI; TSX: QLT) today announced that twelve-month primary analysis results from the Novartis sponsored Phase II MONT BLANC study were presented on June 14, 2009 during the 17th Congress of the European Society of Ophthalmology in Amsterdam, the Netherlands. MONT BLANC is the European study of the Novartis sponsored SUMMIT clinical trial program which investigates the efficacy and safety of combining Visudyne(R) (Novartis Pharma AG) and Lucentis(R) (Novartis Pharma AG, Genentech Inc.). SUMMIT also includes the DENALI study in the US and Canada and the EVEREST study in Asia. MONT BLANC is a 24-month randomized, double-masked, multicenter trial in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. The purpose of the study is to evaluate whether Visudyne combined with Lucentis is not inferior to Lucentis monotherapy with respect to the mean change from baseline in visual acuity (VA) and to evaluate the proportion of patients with a treatment-free interval of at least three months duration after Month 2. At the Month 12 examination, mean VA in the Visudyne combination therapy group improved 2.5 letters from baseline compared with a 4.4 letter improvement in the Lucentis monotherapy group. In the combination therapy group, 96% of patients had a three-month treatment-free interval, compared with 92% in the Lucentis monotherapy group.

Twelve-month results of the MONT BLANC study show that combining standard-fluence Visudyne with Lucentis 0.5 mg can deliver VA improvements that are non-inferior to a Lucentis monotherapy regimen with three Lucentis loading doses followed by injections on a monthly as-needed basis (non-inferiority margin of 7 letters). There was no significant difference between the combination and monotherapy groups with regard to proportion
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SOURCE QLT Inc.
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