Biofrontera announces last-patient-out in Phase 2b study of Ameluz topical gel

Biofrontera announced that the final patient in its Phase 2b clinical trial evaluating Ameluz for the treatment of moderate to severe acne vulgaris completed participation on August 22, 2025. Biofrontera’s Phase 2b trial is a multicenter, randomized, double-blind study comparing Ameluz with vehicle gel for the treatment of moderate to severe acne vulgaris using red-light Photodynamic Therapy. Following application of one tube of Ameluz or vehicle gel to the entire face, participants were incubated for either 1 or 3 hours before illumination with the BF-RhodoLED lamp. Up to 3 PDT sessions were performed at monthly intervals and participants were followed up for an additional 2 months after receiving the last PDT. Biofrontera expects to receive top-line data in Q1 2026. Pending positive results, the Company intends to present the findings to the U.S. Food Drug Administration in early Q3 2026 as the basis for a future Phase III program, with the goal of achieving approval for Ameluz PDT for the treatment of acne vulgaris.