Visudyne evaluation indicates positive results

June 10, 2009

Positive twelve-month primary analysis results from the Phase II RADICAL study (Reduced Fluence Visudyne Anti-VEGF-Dexamethasone In Combination for AMD Lesions) in patients with wet age-related macular degeneration (wet AMD) have been announced by QLT Inc.

Positive twelve-month primary analysis results from the Phase II RADICAL study (Reduced Fluence Visudyne Anti-VEGF-Dexamethasone In Combination for AMD Lesions) in patients with wet age-related macular degeneration (wet AMD) have been announced by QLT Inc.

The purpose of the study is to determine if Visudyne combined with Lucentis reduces retreatment rates compared with Lucentis monotherapy, while maintaining similar vision outcomes and an acceptable safety profile. Three Visudyne-Lucentis combination therapies were evaluated against Lucentis monotherapy. The overall results showed that fewer retreatment visits were required with the combination therapies than with Lucentis monotherapy, and the differences were statistically significant: 1. Triple therapy with quarter-fluence Visudyne followed by Lucentis and then dexamethsone (P=.04) 2. Triple therapy with half-fluence Visudyne followed by Lucentis and then dexamethsone (P 3. Double therapy with half-fluence Visudyne followed by Lucentis (P=.04)

While the mean visual acuity (VA) may appear to have improved similarly across all treatment groups, the confidence intervals were wide. There were no unexpected safety findings, and adverse event incidence was similar across treatment groups.

Of the four treatment groups, the triple therapy half-fluence group demonstrated the best results, with the fewest retreatment visits and mean VA improvement most similar to Lucentis monotherapy through 12 months. Patients in the triple therapy half-fluence group had a mean of 3.0 retreatment visits compared with 5.4 for patients who received Lucentis monotherapy (P less than .001). At the month 12 examination, mean VA in the triple therapy half-fluence group improved 6.8 letters from baseline compared with 6.5 letters in the Lucentis monotherapy group (P=.94). While all combination groups had significantly fewer retreatment visits than the Lucentis monotherapy group, the better results (both in VA change and retreatment visits) in the triple therapy half-fluence group compared with the other combination groups was a trend and was not statistically different. Mean retreatment visits and VA improvement for each treatment group are presented in the table below. All results presented are based on ITT analyses; per-protocol analyses yielded similar results. Patients were evaluated for VA and safety, and to assess if retreatment was needed, at visits every month over 12 months of study follow-up. Overall, 10 patients discontinued the study by 12 months for reasons unrelated to Visudyne or Lucentis."The ability of Visudyne-Lucentis triple therapy to decrease the number of retreatment visits for patients while showing vision improvement and an acceptable safety profile is very encouraging," said Allen C. Ho, M.D., Retina Diagnostic & Treatment Assoc., LLC, and one of the two lead investigators for the study. "The RADICAL study has validated our therapeutic approach to wet AMD," said Henry Hudson, M.D., Retina Centers, PC, the other lead investigator for the study.

“Wet AMD is an ocular disease that afflicts people of advanced age, and doctor visits can be onerous to the patient and the patient's caregiver,” said Bob Butchofsky, chief executive officer of QLT Inc. “We are very pleased that the RADICAL study demonstrated that Visudyne combination therapy with Lucentis with or without dexamethasone has the potential to significantly decrease patient burden by reducing the number of doctor visits. We have showed combination therapy with Visudyne significantly reduces the need for retreatment visits through 12 months, which we believe is a great outcome. In addition to reducing retreatment visits, we also believe that Visudyne combination therapy is a potential cost effective way to treat patients with wet AMD.”

The results for secondary VA endpoints in the RADICAL study (percentage of patients with VA improvement equal to or greater than 15 letters, VA change equal to or greater than zero letters, and VA loss less than 15 letters) were consistent with the primary VA endpoint. Ocular adverse events considered associated with treatment were reported for 33% of patients in the combination therapy groups, compared with 27% of patients in the Lucentis monotherapy group. The higher incidence of these events with combination therapy is primarily due to vision disturbance events (abnormal vision 5 to 10% and decreased vision 5 to 8%), which are transient and known to be associated with Visudyne therapy.

The full results of the 12-month primary analysis of the study are expected to be presented at a scientific meeting in the autumn.

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