Ameluz: Preliminary Phase III data

Preliminary data from a double-blind, German Phase III trial in 87 patients with mild to moderate actinic keratosis showed that a significantly greater proportion of patients who received a maximum of 2 treatments of Ameluz were completely clear of any actinic keratosis at 3 months after the last treatment vs. placebo (90.9% vs. 21.9%, p<0.0001). Only 38.2% of patients in the Ameluz arm required a second treatment. Additionally, the cosmetic outcome was "very good" or "good" in 66.7% of patients who received Ameluz vs. 34.6% for placebo. By the end of 1Q15, Biofrontera plans to submit an NDA to FDA for Ameluz. ...