QLT reports positive 12-month results for trial of AMD combination therapy

VANCOUVER, British Columbia — QLT has announced positive 12-month results from its phase 2 RADICAL study, according to a press release from the company.

The randomized, multicenter, single-masked RADICAL study (Reduced fluence Visudyne anti-VEGF-dexamethasone in combination for AMD lesions) is comparing the re-treatment rates and visual outcomes of three combination therapies. Specifically, the investigators are comparing reduced-fluence Visudyne (verteporfin, Novartis/QLT) and Lucentis (ranibizumab, Genentech) combination therapy, either with or without dexamethasone, with a ranibizumab monotherapy among 162 patients with choroidal neovascularization due to age-related macular degeneration.

Patients were randomized to receive quarter-fluence verteporfin followed within 2 hours by ranibizumab and dexamethasone; half-fluence verteporfin followed within 2 hours by ranibizumab and dexamethasone; half-fluence verteporfin followed within 2 hours by ranibizumab; or ranibizumab monotherapy administered for the first 2 months followed by injections on an as-needed basis. After mandatory treatment, all groups received subsequent treatment on an as-needed basis.

Twelve-month results showed that statistically significantly fewer re-treatments were required with the combination therapies than with ranibizumab monotherapy, the release said. Of the four treatment groups, the triple therapy half-fluence group demonstrated superior results, with the fewest re-treatment visits (three) and mean visual acuity improvement most comparable to ranibizumab monotherapy, according to the release.

Overall, 10 patients discontinued the study for reasons unrelated to verteporfin or ranibizumab.

While the study is set for a 24-month duration, QLT plans to present the full results of the 12-month primary analysis at a scientific meeting later this year.