QLT reports final 24-month results from Phase II RADICAL study in patients with wet AMD

Jun 22 2010

QLT Inc. (Nasdaq:QLTI) (TSX:QLT) today announced final 24-month results from the Phase II RADICAL study (Reduced Fluence Visudyne Anti-VEGF-Dexamethasone In Combination for AMD Lesions) in patients with exudative (wet) age-related macular degeneration ("wet AMD"). The purpose of the study was to determine if Visudyne^® combined with Lucentis^® reduced 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 results of the final 24-month analysis are consistent with the primary analysis results after 12 months of follow-up. The 24-month results showed that significantly fewer retreatment visits were required with combination therapies than with Lucentis monotherapy. Mean visual acuity (VA) change from baseline was not statistically different among the treatment groups, although the sample sizes were insufficient to draw definitive conclusions regarding visual acuity outcomes. Overall adverse event incidence was similar across treatment groups, with no unexpected safety findings.

Of the four treatment groups, the triple therapy half-fluence group had the fewest retreatment visits compared with Lucentis monotherapy. Through 24 months, patients in the triple therapy half-fluence group had a mean of 4.2 retreatment visits compared with 8.9 for patients who received Lucentis monotherapy (P<.001). In the second year, the average number of retreatment visits in the triple therapy half-fluence group (1.2) was approximately one-third that of the Lucentis monotherapy group (3.0). At the month 24 examination, mean VA in the triple therapy half-fluence group improved 1.8 letters fewer (95% confidence interval 11.1 letters fewer to 7.6 letters better) compared with the Lucentis monotherapy group.

P values are from comparison with Lucentis monotherapy

CI: confidence interval

"Visudyne–Lucentis combination therapy significantly decreased the number of retreatment visits required over two years, while patients' vision outcome was maintained within one line with an acceptable safety profile, compared with Lucentis alone," said Henry Hudson, M.D., Retina Centers, PC, one of the two lead investigators for the study. "The two-year results from the RADICAL study are consistent with the primary one-year results and demonstrate that combination therapy is a potential treatment option for patients with wet AMD," said Allen C. Ho, M.D., Mid Atlantic Retina and Professor of Ophthalmology Wills Eye Institute Philadelphia, and the other lead investigator for the study.

"The significant reduction in retreatment visits shown for Visudyne–Lucentis combination therapy in the RADICAL study has potential to reduce the number of doctor visits for patients with wet AMD," said Bob Butchofsky, President and Chief Executive Officer of QLT Inc. "We are very pleased that these final RADICAL study results show not only reduction in retreatment visits, but also acceptable vision outcome and safety profile compared with Lucentis monotherapy. These two-year findings help support the view that Visudyne combination therapy is a potentially beneficial way to treat patients with 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 results for the primary VA endpoint (mean VA change from baseline). Ocular adverse events considered associated with treatment were reported for 30 to 38% 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, which are transient and known to be associated with Visudyne therapy.

The full results of the 24-month final analysis of the study will be presented at the 28^th Annual Meeting of the American Society of Retina Specialists (ASRS) in late August.