Biofrontera Inc. disclosed that its Phase 3 study of Ameluz® photodynamic therapy (PDT) for mild to moderate actinic keratoses (AK) on the extremities, neck, and trunk met its primary endpoint, achieving a 45.6 % complete clearance rate versus 16.7 % in the vehicle arm (p < 0.0003). The trial enrolled 172 patients, with 136 receiving Ameluz® gel and 36 receiving vehicle gel, and used the company’s RhodoLED® XL or BF‑RhodoLED® lamps for light activation.
The study’s secondary outcomes were equally encouraging: lesion‑level clearance reached 73.1 % in the full analysis set, and 75.2 % of patients rated the treated skin as “good” or “very good.” 86.3 % of participants indicated they would choose PDT again for future treatment, underscoring strong patient satisfaction and the therapy’s cosmetic acceptability.
From a business perspective, the data support a broader indication that extends Ameluz® beyond the face and scalp to high‑burden AK fields on the trunk and extremities. This expansion could unlock a substantially larger market, as AK is the most common skin condition diagnosed by U.S. dermatologists and can progress to squamous cell carcinoma if untreated. Biofrontera’s preliminary Q4 2025 revenue figures, driven by Ameluz® sales and a December pricing adjustment, reached a record high, but the company continues to face negative revenue growth and declining gross margins, highlighting the need for disciplined cost management as the product line expands.
Regulatory guidance is clear: Biofrontera plans to submit a supplemental New Drug Application to the FDA in the third quarter of 2026, positioning the company to seek approval for the expanded indication. The trial concluded on September 3 2025, with a 12‑month follow‑up expected to finish in the second quarter of 2026, providing a robust data set for the sNDA submission.
Market reaction to the announcement was muted, with investors remaining cautious despite the positive clinical data. Analysts noted that while the trial results are a significant milestone, the company’s ongoing financial challenges—such as declining gross margins and the need for additional capital to support the expanded indication—may temper enthusiasm.
CEO Hermann Luebbert emphasized the clinical and commercial significance of the findings, stating, “These data support Ameluz’s potential to treat broader, high‑burden AK fields beyond the face and scalp.” He added that the company remains focused on executing its growth strategy while managing costs to preserve margin integrity.
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