QLT Inc. Eye Drug, Lucentis Cuts Need to Revisit Doctor

VANCOUVER, British Columbia, Jun 22, 2010 (GlobeNewswire via COMTEX) -- QLT Inc. 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(R) combined with Lucentis(R) 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=.71). Mean retreatment visits and mean VA change from baseline for each treatment group are presented in the table below. All results presented are based on per-protocol analyses. Patients were evaluated for VA and safety over the 24-month follow-up period. Patients were assessed to determine if retreatment was needed at each follow-up visit from Month 1 (combination therapy groups) or Month 3 (Lucentis monotherapy group), except for the final visit. Overall, 21 patients discontinued the study early for reasons unrelated to Visudyne or Lucentis.