Biofrontera Inc. Reports Positive Phase 2b Clinical Trial Results for Ameluz® PDT in Moderate to Severe Acne Vulgaris

Key Highlights

• Biofrontera Inc. (Nasdaq: BFRI) announced positive topline results from its Phase 2b trial evaluating Ameluz® (aminolevulinic acid HCL) topical gel, 10% with photodynamic therapy (PDT) for moderate to severe acne vulgaris.
• The trial identified a 3-hour incubation regimen as the most promising protocol, delivering significantly greater reductions in inflammatory acne lesions compared to vehicle (placebo) gel.
• This indication, if approved, could meaningfully expand Ameluz®’s market potential beyond its current use in actinic keratosis and strengthen Biofrontera’s dermatology pipeline.

Detailed Study Results

The multicenter, randomized, double-blind Phase 2b trial recruited patients with moderate to severe acne vulgaris. Participants received either Ameluz® or vehicle gel applied to the entire face, followed by either a 1-hour or 3-hour incubation period prior to illumination with the BF-RhodoLED® lamp. Up to three treatments were administered at one-month intervals, with follow-up continuing for two months after the final treatment.

• Co-primary endpoints: (1) Relative reduction in inflammatory lesion counts, and (2) Improvement of at least two grades on a 5-point modified Investigator Global Assessment (mIGA) scale, with patients reaching a status of “clear” or “almost clear.”
• Efficacy data from the 3-hour incubation group:
  • Ameluz® group (n=20): 57.97% reduction in inflammatory lesions.
  • Vehicle group (n=14): 36.51% reduction.
  • mIGA endpoint: 25% of Ameluz® patients achieved “clear” or “almost clear,” compared to 21.4% with vehicle.
  • Absolute lesion count reductions (Ameluz® vs. vehicle):
    – Inflammatory: 19.7 vs. 15.4
    – Non-inflammatory: 23.1 vs. 16.5
    – Total: 42.7 vs. 31.9
• Safety and Tolerability: Ameluz® PDT was generally well-tolerated, with adverse events mainly consisting of mild to moderate burning sensation and pruritus. Pain scores during treatment (on an 11-point scale) averaged 3.4 to 3.8 in the Ameluz® group and 2.0 to 2.1 in the vehicle group.
• Patient Satisfaction: High satisfaction was reported, with 85.7% of patients in the 3-hour Ameluz® group stating they would choose PDT again, and 71.4% rating their aesthetic outcome as “good” or “very good.”

Potential Market Impact and Shareholder-Relevant Details

• Acne vulgaris is one of the most prevalent dermatological conditions, representing a substantial market opportunity. Current standard treatments (topicals, antibiotics, oral isotretinoin) have limitations including safety concerns and growing antibiotic resistance.
• Photodynamic therapy (PDT) offers a physician-administered, in-office alternative that may drive higher compliance and avoid chronic systemic exposure.
• The expansion of Ameluz®’s label to include acne vulgaris could be highly price-sensitive and transformative for Biofrontera, given the large patient population and commercial potential.
• The company plans to present these results to the U.S. Food and Drug Administration (FDA) in Q3 2026 to discuss next steps in development. Positive engagement with the FDA could be a future catalyst for the share price.
• The study’s success supports Biofrontera’s strategic goal of extending Ameluz®’s indications, reinforcing its commitment to the photodynamic therapy market.

Management and Investigator Commentary

Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc., highlighted that the results bring Biofrontera closer to offering an effective and well-tolerated option for moderate to severe acne, and that expanding Ameluz®’s indications would strengthen the company’s dermatology franchise.

Dr. Mitchel P. Goldman, the study’s coordinating investigator, noted the significance for patients who currently rely on burdensome regimens, emphasizing the promise of Ameluz® PDT as an alternative.

About Biofrontera Inc.

Biofrontera is a U.S.-based biopharmaceutical company specializing in photodynamic therapy for dermatological conditions. Its flagship product, Ameluz®, is currently commercialized for actinic keratosis, with ongoing trials for non-melanoma skin cancers and moderate-to-severe acne.

Forward-Looking Statements

Certain statements in this article may constitute “forward-looking statements” which are subject to risks and uncertainties, including but not limited to clinical trial outcomes, regulatory review processes, and commercial opportunities. Actual results may differ materially from those anticipated.

Disclaimer

This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own research and consult with a qualified financial advisor before making investment decisions. The author does not hold any position in the securities mentioned.

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