Biofrontera (NASDAQ:BFRI) has achieved a significant clinical milestone, announcing that its Phase 3 trial of Ameluz® photodynamic therapy (PDT) met its primary endpoint for the treatment of mild-to-moderate actinic keratoses (AK) located on the extremities, neck, and trunk.
The results, released February 9, 2026, demonstrate that the therapy significantly outperformed the vehicle control, providing a robust clinical foundation for the company’s planned expansion beyond its current face and scalp indications.
In the trial’s full analysis set, subject complete clearance reached 45.6% for those treated with Ameluz® compared to just 16.7% for the vehicle group (p<0.0003).
The Per Protocol Set showed even stronger results, with clearance rates of 53.2% versus 22.2% (p<0.001).
Total lesion clearance—a key secondary metric—was recorded at 73.1% in the full analysis set and rose to 80.3% in the Per Protocol Set.
Beyond the data, investigators highlighted favorable cosmetic outcomes and high patient satisfaction, which are critical drivers for adoption in the aesthetic-conscious dermatology market.
The success of this trial marks a pivotal moment for the Woburn-based biopharmaceutical firm as it seeks to address a major unmet need; AK lesions on the extremities and trunk are notoriously difficult to treat compared to those on the face.
Biofrontera confirmed it remains on track to submit a supplemental New Drug Application (sNDA) to the FDA in the third quarter of 2026.
If approved, the label expansion could significantly broaden the addressable market for Ameluz®, positioning it as a versatile, field-directed treatment for sun-damaged skin across the entire body.