Final results from Visudyne Phase IIIb DENALI study presented at World Ophthalmology Congress

Jun 16 2010

QLT Inc. (Nasdaq:QLTI) (TSX:QLT) today announced that final results from the Novartis-sponsored Phase IIIb DENALI study were presented on June 8, 2010 during the World Ophthalmology Congress in Berlin. DENALI was a 24-month randomized, double-masked, multicenter trial in patients with subfoveal choroidal neovascularization secondary to wet age-related macular degeneration (all lesion types). The purpose of the study was to evaluate if Visudyne® (verteporfin PDT; Novartis Pharma AG, QLT Inc.) (either reduced- or standard-fluence) combined with Lucentis® (ranibizumab; Novartis Pharma AG, Genentech Inc.) was not inferior (with a non-inferiority margin of seven letters) to monthly Lucentis monotherapy with respect to the mean change from baseline in visual acuity (VA) and to evaluate the proportion of patients with a Lucentis treatment-free interval of at least three months duration after Month 2 until Month 11.

Twelve-month results of the DENALI study show that combining Visudyne with Lucentis with three Lucentis loading doses followed by additional injections on a monthly as-needed basis can improve visual acuity at Month 12 in patients with subfoveal choroidal neovascularization (CNV) secondary to wet age-related macular degeneration (wet AMD). At Month 12, patients in the standard fluence combination group gained on average 5.3 letters from baseline and patients in the reduced fluence combination group gained on average 4.4 letters. Patients in the Lucentis monthly monotherapy group gained on average 8.1 letters at Month 12. DENALI did not demonstrate non-inferior visual acuity gain for Visudyne combination therapy compared with Lucentis monthly monotherapy.

Most patients in the Visudyne combination groups (93% for standard fluence and 84% for reduced fluence) had a Lucentis treatment-free interval of at least three months during the study. On average, patients in the combination groups required 2.2 (standard fluence), 2.8 (reduced fluence) additional Lucentis injections after the mandatory three loading doses. This compared to an average of 7.6 additional injections in the Lucentis monthly monotherapy group. There were no unexpected safety findings, and both combination therapy and Lucentis monotherapy were well tolerated.

"This study adds support that Visudyne combination therapy can improve visual outcomes and may provide a treatment alternative that has the potential to reduce the treatment burden for patients with wet AMD," said Bob Butchofsky, President and Chief Executive Officer of QLT.

"We are heartened by these results and look forward to better understanding what this data might mean for patients clinically, especially with respect to current treatment patterns," said Dipak Panigrahi, MD, Chief Medical Officer of QLT.