The final patient has completed treatment in Biofrontera Inc.’s Phase 2b clinical trial evaluating aminolevulinic acid hydrochloride (Ameluz) for the treatment of moderate- to-severe acne vulgaris (AV).
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 3 program, with the goal of achieving approval for Ameluz Photodynamic Therapy (PDT) for the treatment of acne vulgaris.
Biofrontera’s Phase 2b trial is a multicenter, randomized, double-blind study comparing Ameluz with vehicle gel for the treatment of moderate-to-severe AV using red-light PDT. Following application of one tube of Ameluz or vehicle gel to the entire face, participants were incubated for either one or three hours before illumination with the BF-RhodoLED lamp. Up to three PDT sessions were performed at monthly intervals, and participants were followed up for an additional two months after receiving the last PDT.
“Ameluz PDT has demonstrated meaningful benefits in other dermatologic conditions, and we believe it will become an important option for patients with moderate-to- severe acne vulgaris,” says Mitchel P. Goldman, MD, FAAD, the Coordinating Investigator of the study and Medical Director of Cosmetic Laser Dermatology and Platinum Dermatology Partners in San Diego, CA, in a news release. “Many of these patients continue to rely on regimens that carry significant treatment burdens including cost, adverse effects and the necessity for prolonged treatments. Expanding the use of Ameluz to treat acne would be a valuable advancement for both physicians and patients. We look forward to the study results with great anticipation.”
