Biofrontera (NASDAQ:BFRI) announced completion of patient enrollment in the Phase 3 study of Ameluz topical gel for the treatment of Actinic Keratoses (AKs) on the extremities, neck, and trunk with photodynamic therapy (PDT).
According to Biofrontera, this is the first U.S.-based Phase 3 study of PDT to include neck, trunk, and extremities—expanding field treatment options for patients with AKs beyond the face and scalp—addressing a critical unmet need in dermatology. The company anticipates finishing the treatment phase of the study by September 2025 with follow-up phase completed by the second quarter of 2026.
Dr. Hermann Leubbert, CEO and chairman of Biofrontera, commented, “We are thrilled to reach this pivotal stage in our clinical program. The successful enrollment of our last patient brings us one step closer to potentially offering an effective treatment option for patients with AKs on the extremities, neck, and trunk. It marks a significant step in expanding the indications for Ameluz and further demonstrates our commitment to the development of PDT.”
