QLT Inc. announced last week positive twelve month 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. 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<.001)
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<.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.

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