Biofrontera says last patient completes treatment in Phase 3 study of Ameluz

Biofrontera announced that the final patient completed the active treatment phase of its Phase 3 clinical trial evaluating Ameluz PDT for mild to moderate actinic keratoses on the extremities, neck and trunk on September 3, 2025. All 172 enrolled patients have now entered the 12-month follow-up phase, expected to conclude in Q2 2026. 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 actinic keratoses 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 cm. 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. In total, 172 subjects were enrolled in the study. “We are delighted to reach this stage in our clinical program,” said Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc. (BFRI) “Building on the recent FDA approval for the use of up to 3 tubes of Ameluz per treatment, today’s milestone marks another step in broadening the label and market potential for this product. Together, these developments reflect Biofrontera’s strategic progress toward leadership in PDT.” 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 to the Food and Drug Administration (FDA) that same quarter.