Biofrontera reaches final patient visit for acne treatment trial.

Biofrontera has completed its Phase 2b clinical trial for Ameluz (aminolevulinic acid hydrochloride) in moderate to severe acne vulgaris. The final patient visit marks a key milestone, with top-line results expected in Q1 2026. The company plans to discuss the results with the FDA in Q3 2026 to advance the Phase 3 program and potentially expand the drug's label. Acne affects over 50 million people in the US annually, with a market valued at $5.7 billion in 2024.

Biofrontera Inc. (NASDAQ: BFRI) has completed the final patient visit in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris. The trial, a multicenter, randomized, double-blind study comparing Ameluz® with vehicle gel using red-light Photodynamic Therapy (PDT), has reached a significant milestone. Top-line results are expected in Q1 2026, with the company planning to discuss the findings with the FDA in Q3 2026 to advance the Phase 3 program and potentially expand the drug's label.

Acne vulgaris affects an estimated 50 million people in the US each year, with a market valued at $5.7 billion in 2024 [1]. The condition, characterized by inflammatory and non-inflammatory lesions, often leads to permanent scarring and psychological impacts such as reduced self-esteem and depression. Current treatments, including topical agents, systemic antibiotics, hormonal therapies, isotretinoin, and physical treatments, face limitations such as serious side effects, teratogenic risks, and antibiotic resistance. This unmet need highlights the potential of Ameluz® as an alternative treatment option.

Biofrontera's Phase 2b trial involved up to 3 PDT sessions at monthly intervals, with participants receiving either 1 or 3-hour incubation before BF-RhodoLED® lamp illumination. The study was designed to assess the efficacy and safety of Ameluz® PDT in treating moderate to severe acne vulgaris. Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc., expressed optimism about the trial's results, stating that it brings the company closer to offering a new, effective treatment option for patients. Dr. Mitchel P. Goldman, MD, FAAD, the coordinating investigator, also noted the potential impact of Ameluz® PDT in addressing the significant treatment burden faced by patients with acne.

The completion of the last patient visit in the Phase 2b trial positions Biofrontera for potential label expansion of their existing photodynamic therapy technology into a substantial new market. The acne treatment landscape presents a compelling opportunity, with a market size of $5.7 billion and a projected compound annual growth rate (CAGR) of 5.3% [2].

References:
[1] https://www.globenewswire.com/news-release/2025/08/25/3138453/0/en/Biofrontera-Inc-Announces-Last-Patient-Out-in-Phase-2b-Study-of-Ameluz-aminolevulinic-acid-HCI-Topical-Gel-10-for-the-Treatment-of-Moderate-to-Severe-Acne-Vulgaris.html
[2] https://www.stocktitan.net/news/BFRI/biofrontera-inc-announces-last-patient-out-in-phase-2b-study-of-pnv3e3h5nr7l.html