17 September 2019 - Biofrontera has filed a label extension for Ameluz with the EMA on August 28, 2019 to include treatment of mild and moderate actinic keratosis of the extremities and trunk/neck with photodynamic therapy. 

The submission follows the positive treatment outcomes demonstrated for Ameluz in the recent phase III trial.

Biofrontera has also entered into discussions with the U.S. FDA for approval in the U.S. and will report separately on this matter as soon as a schedule has been agreed upon with the FDA.

Read Biofrontera press release