FDA Approves Skin Condition Rx

The US Food and Drug Administration (FDA) has approved Ameluz (aminolevulinic acid) to treat a particular skin condition.

Ameluz was approved to treat actinic keratosis, a skin condition marked by rough, scaly skin lesions that have resulted from prolonged exposure to the sun. These skin lesions are typically found on the face, scalp, lips, arms and hands.

Treatment of actinic keratosis is important because it can turn into a type of skin cancer if not treated.

Biofrontera's Ameluz was approved to treat mild to moderate actinic keratosis (AK) on the face and scalp, in combination with photodynamic therapy (PDT) using BF-RhodoLED.

BF-RhodoLED, considered a medical device, is a lamp that produces red light and activates the medication.

In clinical trials, Ameluz was shown to be more effective than the standard of care. In fact, clinical trial data revealed a complete patient response rate of 91 percent. Data also suggested that Ameluz decreased the chance for recurrence over 12 months.

Biofrontera expects to launch Ameluz in the US by the fall of 2016.