Biofrontera Submits FDA Application for Ameluz-PDT in Superficial Basal Cell Carcinoma Treatment
Key Insights
Biofrontera Inc. submitted a supplemental New Drug Application to the FDA on November 28, 2025, seeking approval for Ameluz-PDT to treat superficial basal cell carcinoma (search).
The Phase 3 study demonstrated 65.5% complete clearance rates with Ameluz-PDT versus 4.8% with placebo, achieving highly significant statistical results (p<0.0001).
Secondary endpoints showed even higher efficacy rates, with 75.9% histological clearance and 83.4% clinical clearance compared to placebo controls.
Biofrontera Inc. has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (search) seeking approval of Ameluz-PDT for the treatment of superficial basal cell carcinoma (search) (sBCC), marking the first Phase 3 photodynamic therapy study for this indication in the United States. The submission, filed on November 28, 2025, represents a potential expansion into cutaneous oncology for the biopharmaceutical company specializing in photodynamic therapy development.
Phase 3 Study Results Demonstrate Strong Efficacy
The double-blind, randomized, placebo-controlled, multi-center Phase 3 study evaluated 187 patients with one or more clinically and histologically confirmed superficial BCCs. Participants received one cycle of two PDT treatments (either Ameluz-PDT or placebo-PDT) administered 1-2 weeks apart, with a potential second treatment cycle at three months if required.
The study's primary endpoint measured complete clinical and histological clearance of one preselected "main target lesion" at 12 weeks after the start of the last PDT cycle. Results showed a 65.5% clearance rate in the Ameluz-PDT arm (95/145 subjects) compared to 4.8% in the placebo-PDT arm (2/42 subjects), achieving highly significant statistical difference (p<0.0001).
Secondary Endpoints Show Enhanced Treatment Benefits
Key secondary endpoints demonstrated even stronger efficacy outcomes. Complete histological clearance of the main target lesion was achieved in 75.9% (110/145) of patients treated with Ameluz compared to 19.0% (8/42) with placebo. Complete clinical clearance reached 83.4% (121/145) of Ameluz-treated patients versus 21.4% (8/42) with placebo. Total clearance of all sBCC lesions occurred in 64.1% of subjects treated with Ameluz compared to 4.8% with placebo, with all endpoints achieving p<0.0001 statistical significance.
Patient-reported outcomes supported these clinical findings, with 85.5% of patients rating overall treatment satisfaction and aesthetic outcomes with Ameluz-PDT as very good or good. One-year follow-up data reinforced treatment durability, demonstrating low recurrence rates and excellent aesthetic outcomes.
Clinical and Regulatory Significance
"We are delighted that these highly significant results align with those found in the European studies and that we were able to submit this data package to FDA and seek an extension of the label to include sBCC," stated Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc. "If approved, this would expand the Ameluz indication to cutaneous oncology and would represent a significant milestone in our mission to become market leaders in the field of PDT."
The submission includes comprehensive efficacy data from the Phase 3 treatment phase and one-year follow-up, combined with an integrated safety assessment incorporating data from Biofrontera's U.S. and European basal cell carcinoma (search) clinical studies. The filing seeks to expand the Ameluz label to include sBCC treatment with PDT using BF-RhodoLED or RhodoLED XL red light lamps.
Market Context and Clinical Need
Basal cell carcinoma (search) represents the most common skin cancer (search) in the United States, with more than 3 million cases diagnosed annually. Dr. Todd Schlesinger, board certified dermatologist and Mohs surgeon, Director of the Clinical Research Center of the Carolinas in Charleston, South Carolina, and first author of the recent publication of the Phase 3 results in the Journal of the American Academy of Dermatology, commented: "The efficacy, tolerability, and aesthetic outcomes demonstrated in the Phase 3 study and highlighted in our publication reinforce the value of Ameluz-PDT for the treatment of sBCC. I look forward to potentially having this as an approved option for my patients with sBCC."
The company currently commercializes Ameluz with the RhodoLED lamp series for photodynamic therapy of actinic keratosis (search), pre-cancerous skin lesions that may progress to invasive skin cancers. Biofrontera continues conducting clinical trials to extend product use for treating non-melanoma skin cancers and moderate-to-severe acne.