Biofrontera planning applications to expand Ameluz indication

Biofrontera said it will submit regulatory applications to FDA and EMA in 3Q19 to expand the indication of Ameluz to include treatment of actinic keratoses lesions on the extremities. The decision follows Phase III data in which the photodynamic therapy met the primary endpoint in patients with 4-10 actinic keratoses lesions in comparable areas on the right and left side of the extremities and/or trunk or neck.

The double-blind, German trial enrolled 50 patients. On the primary endpoint, Biofrontera AG (Xetra:B8F; NASDAQ:BFRA) said Ameluz followed by red light illumination significantly improved mean total lesion clearance rate vs. placebo at three months after the last treatment (86% vs. 33%, p<0.0001)...