Biofrontera Inc. (BFRI) announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz photodynamic therapy (PDT) with RhodoLED red-light lamp for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk- successfully meeting the study's primary endpoint.
Actinic keratosis is the most common skin condition diagnosed by U.S. dermatologists, and if left untreated, may progress to squamous cell carcinoma. The Phase 3 study was designed to assess whether Ameluz PDT could effectively treat broader, high-burden AK fields beyond the face and scalp.
The multicenter, randomized, double-blind, vehicle-controlled trial enrolled 172 patients, randomized 4:1 to receive Ameluz gel or vehicle gel. Treatment fields ranged from approximately 80 to 240 cm2, with patients receiving one PDT session and a second at Week 12 if lesions remained. Participants will be followed for about one year after their final treatment.
The primary endpoint- subject complete clearance rate at 12 weeks after the last PDT session- showed highly statistically significant superiority for Ameluz PDT. In the Full Analysis Set, complete clearance was achieved in 45.6% of Ameluz-treated patients versus 16.7% for vehicle. Results were similarly strong in the Per Protocol Set, with clearance rates of 53.2% versus 22.2%.
Key secondary outcomes reinforced the efficacy of Ameluz PDT, including AK lesion clearance rates of 73.1% (FAS) and 80.3% (PPS). Clearance by anatomical region also favored Ameluz, with particularly strong results on the neck and trunk. Cosmetic outcomes were rated "good" or "very good" by both investigators and patients, and more than 86% of patients indicated they would choose PDT again.
"These results represent a critical milestone in our clinical program," said Hermann Luebbert, CEO and Chairman of Biofrontera Inc. He noted that the data support Ameluz's potential to treat larger, high-burden AK fields across multiple sun-exposed areas, expanding its clinical utility beyond the face and scalp.
Nathalie Zeitouni, the study's coordinating investigator, added that many patients present with AK lesions on areas other than the face and scalp, and the findings support expanding treatment options for these patients.
Based on the positive Phase 3 results Biofrontera plans to submit a supplemental New Drug Application to the U.S. FDA in the third quarter of 2026.
BFRI has traded between $0.53 and $1.19 over the past year. The stock is currently trading at $0.74, down 9.16%.
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