Biofrontera Inc. has submitted a supplemental New Drug Application to the FDA seeking approval of Ameluz-PDT for treating superficial basal cell carcinoma, the most common skin cancer in the U.S. with over 3 million annual cases. The submission is supported by Phase 3 trial data of 187 patients, where Ameluz-PDT achieved a 65.5% complete clearance rate of target lesions compared to 4.8% for placebo, alongside low recurrence rates and high patient satisfaction at one-year follow-up.
Supplemental New Drug Application submission
- ▪The supplemental New Drug Application submitted by Biofrontera Inc. on November 28, 2025, includes efficacy data from a Phase 3 study and an integrated safety assessment from clinical trials.
- ▪Biofrontera Inc. submitted a supplemental New Drug Application to the U.S. Food and Drug Administration on November 28, 2025, seeking to treat superficial basal cell carcinoma with Ameluz-PDT using BF-RhodoLED or RhodoLED XL red light lamps.
Phase 3 study efficacy results
- ▪The Phase 3 clinical study of Ameluz-PDT demonstrated complete histological clearance of the main target lesion in 75.9% of patients (19.0% placebo) and complete clinical clearance in 83.4% (21.4% placebo).
- ▪In a Phase 3 clinical study of 187 patients, Ameluz-PDT achieved a 65.5% complete clearance rate of the main target lesion at 12 weeks, compared to 4.8% for placebo.
- ▪In the Phase 3 clinical study, total clearance of all superficial basal cell carcinoma lesions occurred in 64.1% of patients treated with Ameluz-PDT compared to 4.8% with placebo.
Follow-up and patient satisfaction
- ▪In the Phase 3 clinical study of Ameluz-PDT, 85.5% of patients rated their overall treatment satisfaction and aesthetic outcome as very good or good.
- ▪One-year follow-up data from the Phase 3 clinical study of Ameluz-PDT demonstrated low recurrence rates and favorable cosmetic outcomes for patients treated for superficial basal cell carcinoma.
Biofrontera product indications
- ▪Biofrontera Inc. conducts clinical trials to expand the use of its photodynamic therapy products to treat non-melanoma skin cancers and moderate-to-severe acne.
- ▪Biofrontera Inc. commercializes the drug-device combination Ameluz with the RhodoLED lamp series for photodynamic therapy of actinic keratosis.
Prevalence of US skin conditions
- ▪Basal cell carcinoma is the most common skin cancer in the United States, with more than 3 million cases diagnosed annually.
- ▪Approximately 58 million people in the United States were affected in 2020 by actinic keratosis, a pre-cancerous skin lesion that can develop into squamous cell carcinoma.
Debatable claims
- ▪Photodynamic therapy is a reliable alternative to surgery for superficial skin cancer
- ▪Clinical clearance is sufficient to declare superficial skin cancer successfully treated
- ▪Aesthetic outcomes should be prioritized alongside tumor clearance in superficial skin cancer treatments
Story comments
Loading comments…