Biofrontera completes final patient visit in Phase 1 PK study of Ameluz gel

Biofrontera (BFRI) announced the completion of the final patient visit in its Phase 1 pharmacokinetic, PK, study of Ameluz gel, 10%, for the treatment of mild to moderate actinic keratoses on the neck, trunk and extremities. The last patient visit took place on 24 November 2025. Data from this study, together with results from Biofrontera’s recently completed Phase 3 clinical trial, will form the basis of a planned supplemental New Drug Application to the U.S. Food and Drug Administration seeking to expand the Ameluz label to include the treatment of AKs on all peripheral body areas. Actinic keratoses commonly occur on sun-exposed areas across the body and may progress to squamous cell carcinoma if left untreated. Expanding Ameluz’s current FDA approval for use beyond the face and scalp would address a critical unmet need in dermatology.