QLT Provides Results Of Mont Blanc Study

Canada-based QLT has announced 12-month primary analysis results from the Novartis sponsored phase-II Mont Blanc study .

Mont Blanc is the European study of the Novartis sponsored Summit clinical trial program, which investigates the efficacy and safety of combining Visudyne and Lucentis .

Twelve-month results of the Mont Blanc study shows that combining standard-fluence Visudyne with Lucentis 0.5 mg, can deliver visual acuity (VA) improvements. These are non-inferior to a Lucentis monotherapy regimen with three Lucentis loading doses followed by injections on a monthly as-needed basis (non-inferiority margin of 7 letters).

There was no significant difference between the combination and monotherapy groups with regard to proportion of patients with a treatment-free interval of at least three months duration, after month 2.

Additional post hoc analysis showed that 85% of patients in the Visudyne combination therapy group, compared with 72% in the Lucentis monotherapy group, had a treatment-free interval of at least four months duration after month 2.

Patients in the combination group received, on average, a total of 4.8 Lucentis injections compared with 5.1 in the monotherapy group, and a total of 1.7 Visudyne treatments compared with 1.9 sham treatments in the monotherapy group.

Results are based on ITT analyses (with LOCF); per-protocol analyses yielded similar results. Overall, only 6% patients discontinued the study before Month 12.