Biofrontera Announces Completion of Phase 3 Trial for Ameluz PDT Treatment of Actinic Keratoses on Extremities, Neck and Trunk.

Biofrontera Inc. has announced that the final patient has completed the active treatment phase of its Phase 3 clinical trial for Ameluz® (10% 5-aminolevulinic acid hydrochloride gel) PDT for mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk. The trial involves 172 patients and aims to form the basis of a supplemental New Drug Application (sNDA) planned for submission in Q2 2026. The study's results are expected to expand treatment options for AKs beyond the face and scalp, addressing a critical unmet need in dermatology.