Biofrontera Completes Last Patient in Phase 2b Study for Ameluz Topical Gel

Biofrontera has completed the final patient enrollment in its Phase 2b trial for Ameluz topical gel to treat moderate to severe acne vulgaris. Top-line data is expected in Q1 2026, with the aim of presenting findings to the FDA in Q3 2026 to support a future Phase III program and potential approval for Ameluz PDT for acne treatment.

Biofrontera Inc. has announced the completion of the final patient enrollment in its Phase 2b clinical trial evaluating Ameluz topical gel for the treatment of moderate to severe acne vulgaris. The trial, which concluded on August 22, 2025, represents a significant milestone in the company's efforts to expand the indications for Ameluz and advance photodynamic therapy (PDT) as a viable treatment option for acne.

The Phase 2b study was a multicenter, randomized, double-blind trial comparing Ameluz with a vehicle gel for the treatment of moderate to severe acne vulgaris using red-light PDT. Participants applied one tube of Ameluz or vehicle gel to their entire face, followed by incubation for either 1 or 3 hours before illumination with the BF-RhodoLED lamp. Up to three PDT sessions were performed at monthly intervals, with participants followed up for an additional two months after receiving the last PDT.

Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc., expressed his enthusiasm about the trial's completion, stating, "We are thrilled to achieve this important milestone in our clinical program. It brings us a significant step closer to potentially offering a new, effective, and much-needed treatment option for patients with moderate to severe acne vulgaris. This trial represents meaningful progress in expanding the indications for Ameluz and reinforces our commitment to advancing PDT."

Dr. Mitchel P. Goldman, MD, FAAD, the coordinating investigator of the study and Medical Director of Cosmetic Laser Dermatology and Platinum Dermatology Partners, shared his optimism about the potential impact of Ameluz PDT on acne treatment. "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," he said.

Biofrontera expects to receive top-line data from the trial in Q1 2026. If the results are positive, the company plans to present the findings to the U.S. Food and Drug Administration (FDA) in early Q3 2026 to support a future Phase 3 program and potential approval for Ameluz PDT for acne treatment.

Acne vulgaris, the most common skin condition in the United States, affects an estimated 50 million people each year. The condition is characterized by inflammatory and non-inflammatory lesions that can lead to permanent scarring and has a significant psychological impact, including reduced self-esteem and depression. Current U.S. guidelines recommend a range of treatment options, including topical agents, systemic antibiotics, hormonal therapies, isotretinoin, and physical treatments. However, many of these options carry limitations such as serious side effects, teratogenic risks, the need for continuous daily dosing, or growing concerns about antibiotic resistance.

The U.S. acne treatment market, valued at $5.7 billion in 2024 and projected to grow at a 5.3% CAGR, reflects this unmet need. More than 55% of spending is currently directed to oral antibiotics and isotretinoin, underscoring the reliance on systemic therapies and the opportunity for novel treatment approaches.

Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the development and treatment of dermatological conditions with a focus on PDT. The company commercializes the drug-device combination Ameluz with the RhodoLED lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne.

References:

[1] https://drug-dev.com/biofrontera-announces-last-patient-out-in-phase-2b-study-of-ameluz-topical-gel-for-the-treatment-of-moderate-to-severe-acne-vulgaris/
[2] https://www.biospace.com/press-releases/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