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

udyne (180mW/cm2 for 83 seconds to deliver 15 J/cm2) followed within two hours by intravitreal Lucentis (0.5 mg) and then dexamethasone (0.5 mg) Group 4: Lucentis monotherapy (0.5 mg), mandatory injection for initial treatment and the first two months and then PRN

The purpose of the study is to determine if combination therapy reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile. The study duration is 24 months with a planned primary analysis when all subjects complete 12 months of follow-up.

At baseline, mean best corrected visual acuity letter scores ranged from 58 to 53 across treatment groups. At six months, each group had similar mean visual acuity letter score improvements from baseline (Group 1: 4.0 letters; Group 2: 7.3 letters; Group 3: 2.5 letters; Group 4: 4.4 letters). Although cumulative retreatment rates were lower in all combination groups compared with the Lucentis monotherapy group, this was influenced by the mandatory retreatments at months 1 and 2 in the Lucentis monotherapy group. Longer-term follow up is needed to better compare the elective retreatment rates in each group.

"Determining if Visudyne therapy in combination with Lucentis with or without a steroid is a safe approach for a patient with the neovascular or wet form of AMD to maintain, if not improve visual acuity with fewer numbers of retreatments is an important question that this study will help to answer," said Henry Hudson, M.D., a lead investigator for the study. "If indicated by the one-year study results, less treatment frequency with similar vision and safety outcomes would be a positive outcome for patients, as it could mean fewer doctor visits. Based on the six-month data review for Visudyne combination therapy and the DSMC's recommendation, the study will continue as planned."

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SOURCE QLT Inc.
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