Results for the primary endpoint of Biofrontera AG's Phase 3 clinical trial evaluating the safety and efficacy of conventional photodynamic therapy (PDT) with Ameluz and the BF-RhodoLED lamp for the treatment of actinic keratoses (AK) on the extremities as well as the trunk and neck are postive. The study met its primary regulatory endpoint, demonstrating that Ameluz was superior to placebo based on its mean total lesion clearance rate of 86 percent compared to 33 percent for placebo. These results will be utilized for the filing of the label extension with the European Medicines Agency (EMA) and the US FDA, which Biofrontera plans to submit in the third quarter of 2019.
The multi-center, randomized, double-blind, intra-individual study included 50 patients at six study sites in Germany, each with four to ten clinically confirmed AK lesions in comparable areas on the right and left side of the extremities and/or trunk/neck. Mild, moderate and severe actinic keratoses were treated with one or two PDT treatments. The final examination of the patients took place three months after the last PDT treatment. The clinical study phase is now followed by a follow-up phase of 12 months after the last PDT, in which recurrence rates and/or numbers of new AKs and skin tumors are determined.