BFRA - Biofrontera concludes clinical phase of PK study with Ameluz gel in actinic keratoses

Biofrontera ([[BFRA]] -1.9%) has completed clinical phase of pharmacokinetics ((PK)) study to test the safety of photodynamic therapy ((PDT)) using three tubes of Ameluz, at the same time.Ameluz gel is a prescription drug for photodynamic therapy for mild- to-moderate actinic keratoses.The maximal use PK study in 32 actinic keratosis patients received one PDT treatment with three Ameluz tubes either on the face/scalp, or on extremities/trunk/neck. Illumination was performed after 3 hours of occlusion, using either one or two BF-RhodoLED lamps.The company expects to receive results on both pharmacokinetics and safety during this quarter."We expect to submit the report to the FDA by the end of the year. The study is another important milestone in increasing the competitiveness of Ameluz in our markets, particularly in the US," says Hermann Lubbert, CEO.

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Biofrontera concludes clinical phase of PK study with Ameluz gel in actinic keratoses