RADICAL study shows positive 12-month results

Vancouver, British Columbia-QLT Inc. has announced positive 12-month primary analysis results from a phase II study in patients with wet age-related macular degeneration (AMD), known as RADICAL (or Reduced fluence visudyne Anti-VEGF-Dexamethasone In Combination for AMD Lesions).

According to the company, the purpose of the study is to determine whether proprietary verteporfin (Visudyne, Novartis) combined with ranibizumab (Lucentis, Genentech) reduces re-treatment rates compared with ranibizumab monotherapy, while maintaining similar vision outcomes and an acceptable safety profile. The phase II, multicenter, randomized, single-masked study enrolled 162 patients with choroidal neovascularization secondary to wet AMD.

Three verteporfin-ranibizumab combination therapies (with or without dexamethasone) were evaluated against ranibizumab monotherapy. According to the company, the overall results showed that fewer re-treatment visits were required with the combination therapies than with monotherapy, and the differences were statistically significant:

1. Triple therapy with quarter-fluence verteporfin followed by ranibizumab and then dexamethasone (p = 0.04).
2. Triple therapy with half-fluence verteporfin followed by ranibizumab and then dexamethasone (p 3. Double therapy with half-fluence verteporfin followed by ranibizumab (p = 0.04).

Mean visual acuity (VA) appears to have improved similarly across all treatment groups; however, the confidence intervals were wide, the company said. No unexpected safety findings were reported, and adverse event incidence was similar across treatment groups.The second combination therapy group demonstrated the best results with the fewest re-treatment visits, mean 3.0, compared with 5.4 visits for patients who received monotherapy. At the 12-month examination, mean VA in the second combination therapy group improved 6.8 letters from baseline compared with 6.5 letters in the monotherapy group.

“We are very pleased that the RADICAL study demonstrated that [verteporfin] combination therapy with [ranibizumab] with or without dexamethasone has the potential to significantly decrease patient burden by reducing the number of doctor visits,” said Bob Butchofsky, chief executive officer of QLT. “We have showed combination therapy with [verteporfin] significantly reduces the need for re-treatment visits through 12 months, which we believe is a great outcome. In addition to reducing re-treatment visits, we also believe that [verteporfin] combination therapy is a potential cost-effective way to treat patients with wet AMD.”