AT A GLANCE

A phase 3 trial has completed enrollment for Ameluz^® photodynamic therapy in treating actinic keratoses (AKs) on the extremities, trunk, and neck. The study will assess clearance rates, recurrence, and long-term outcomes, with potential to expand treatment options beyond the face and scalp.

Biofrontera has announced the completion of the active treatment phase in a pivotal phase 3 trial evaluating Ameluz^® (10% aminolevulinic acid hydrochloride gel) photodynamic therapy (PDT) for actinic keratoses (AKs) on the extremities, neck, and trunk. While Ameluz is already approved for use on the face and scalp, this study aims to broaden the label to body areas where therapeutic options remain limited. A total of 172 patients were enrolled and randomized to receive either Ameluz PDT or vehicle control, with treatment delivered using RhodoLED® or BF-RhodoLED® XL lamps. Patients received one treatment, with the option for a second at 12 weeks if residual lesions were present.

Actinic keratoses represent one of the most common precancerous dermatologic conditions, affecting more than 58 million U.S. adults, and carry the potential to progress to cutaneous squamous cell carcinoma. The significance of this trial lies in its focus on non-facial/body lesions, which are prevalent but underserved by current therapies. With all participants now entering a 12-month follow-up period, outcomes will provide critical insight into long-term clearance, recurrence, and prevention of new lesions. Pending positive data, Biofrontera expects to submit a supplemental NDA in mid-2026, potentially positioning Ameluz® as the first PDT option for AKs beyond the head and neck.

DRUG AT A GLANCE

Ameluz^® (aminolevulinic acid hydrochloride) is a topical gel approved by the U.S. Food and Drug Administration for use in photodynamic therapy to treat actinic keratoses on the face and scalp.