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QLT announces 12-month results from phase 2 study of combination therapy

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VANCOUVER, British Columbia — QLT has announced 12-month primary results from the European arm of the Novartis-sponsored SUMMIT clinical program.

The randomized, double-masked, multicenter, phase 2 MONT BLANC study is evaluating the efficacy and safety of combining Visudyne (verteporfin, Novartis/QLT) with Lucentis (ranibizumab, Genentech/Novartis) compared with ranibizumab monotherapy among 255 patients with choroidal neovascularization due to wet age-related macular degeneration, according to a press release from QLT.

In the study, patients were randomized to receive either standard-fluence verteporfin followed by intravitreal ranibizumab or ranibizumab monotherapy; patients receiving ranibizumab monotherapy also received sham verteporfin to maintain masking. All verteporfin and sham treatments were administered at baseline and thereafter at intervals of at least 3 months on an as-needed basis. Ranibizumab was administered to both treatment groups with three loading doses followed by monthly treatment on an as-needed basis, according to the release.

At 12 months, the investigators found that mean visual acuity in the combination therapy group had improved by 2.5 letters from baseline compared with a 4.4-letter improvement in the monotherapy group. In addition, 96% of patients in the combination therapy group experienced a 3-month treatment-free interval, compared with 92% of patients in the monotherapy group.

Further post hoc analysis showed that 85% of patients in the combination therapy group experienced a treatment-free interval of at least 4 months after the second month of treatment, compared with 72% of patients receiving monotherapy. The median time to first re-treatment after 2 months was extended by 1 month, to 6 months, in the combination group vs. 5 months in the monotherapy group.

Patients in the combination group received an average of 4.8 ranibizumab injections and 1.7 verteporfin treatments compared with 5.1 ranibizumab injections and 1.9 sham treatments in the monotherapy group, the release said.

Overall, 15 patients (6%) discontinued the study before 12-month analysis; adverse events were similar in both treatment groups.

The SUMMIT trial program also includes the DENALI study in the United States and Canada and the EVEREST study in Asia.