The final patient completed the active treatment phase of Biofrontera Inc.’s Phase 3 trial evaluating Ameluz (10% 5-aminolevulinic acid hydrochloride gel) photodynamic therapy (PDT) for mild-to-moderate actinic keratoses (AKs) on the extremities, neck, and trunk.

All 172 enrolled patients have now entered the 12-month follow-up phase. The 12-month follow-up phase is expected to be completed by Q2 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) that same quarter.

Ameluz PDT vs. Vehicle

This Phase 3 study is a multicenter, randomized, double-blind trial designed to evaluate the safety and efficacy of Ameluz PDT versus vehicle gel in the treatment of AKs on the extremities, neck, and trunk. PDT was administered using a RhodoLED or BF-RhodoLED XL lamp following application of one to three tubes of either Ameluz or vehicle to areas of approximately 80, 160, or 240 cm². Patients received a single PDT treatment, with a second one at 12 weeks if residual lesions remained. They are now being followed for 12 months to assess recurrence and new lesion development.

“We frequently see people with AKs on the trunk and extremities, and current treatment options are limited. Expanding the use of Ameluz PDT to these areas would be a welcome advancement for dermatologists and our patients,” says Study Author Nathalie Zeitouni, MD, Mohs surgeon and clinical investigator at Medical Dermatology Specialists and a Professor of Dermatology at the University of Arizona COM Phoenix, in a news release.