Biofrontera Secures FDA Approval for Ameluz in Skin Cancer

Biofrontera secured U.S. Food and Drug Administration approval for its supplemental New Drug Application for Ameluz topical gel 10% paired with the BF-RhodoLED lamp, clearing the treatment for superficial basal cell carcinoma in adults. According to a StockTitan report, this regulatory clearance establishes Ameluz as the first and only photodynamic therapy approved by the FDA for any skin cancer, and the sole topical photodynamic therapy in the United States indicated for both actinic keratosis and superficial basal cell carcinoma.

"FDA approval of Ameluz for superficial basal cell carcinoma is a defining milestone for Biofrontera," said Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, in a statement. "Ameluz is now the first and only photodynamic therapy approved in the United States to treat a skin cancer, which sets our platform apart in medical dermatology and gives dermatologists an effective, non-surgical option for a very common tumor."

Phase 3 Trial Efficacy and Mechanism

The regulatory decision rests on data from a Phase 3 clinical trial evaluating 187 adult patients. According to the StockTitan announcement, the study demonstrated a complete clinical and histological response at 12 weeks in 66% of patients treated with Ameluz photodynamic therapy, compared with 5% for patients receiving placebo photodynamic therapy.

Photodynamic therapy utilizes a light-sensitizing topical gel combined with specialized red-light illumination to target and destroy abnormal cellular tissue. Superficial basal cell carcinoma represents an early, non-aggressive form of skin cancer that grows on the surface layer of the skin, making localized topical treatments an alternative to surgical excision.

"For many patients with superficial basal cell carcinoma, including those with multiple lesions, lesions in cosmetically sensitive locations, or patients for whom surgery would not be preferred, treatment options have been limited," said Dr. M. Shane Chapman, Professor and Founding Chair of the Department of Dermatology at Dartmouth Hitchcock Medical Center and the Dartmouth Geisel School of Medicine, in a statement. "This FDA approval for Ameluz and the RhodoLED gives us a rigorously studied, non-surgical option..."

Commercial Launch Timeline and Market Position

Following the regulatory clearance, Biofrontera plans an official commercial launch for the superficial basal cell carcinoma indication scheduled between late the fourth quarter of 2026 and the first quarter of 2027. According to the company release, the rollout will utilize Biofrontera's existing commercial organization and established installed base of BF-RhodoLED lamps in dermatology clinics, avoiding the need for upfront capital expenditures to build out a new delivery infrastructure.

In the public markets, shares of Biofrontera Inc. (BFRI) traded at $1.24, marking a 2.48% increase from their previous close of $1.21, according to Finnhub market data as of September 17, 2026.

What the Approval Means for Medical Dermatology

The expansion into superficial basal cell carcinoma broadens Biofrontera's commercial addressable market beyond actinic keratosis, a common pre-cancerous skin condition. By capturing a formal oncology indication, the company positions its photodynamic platform to compete directly with existing surgical, cryogenic, and topical cream treatments used by dermatologists for low-risk skin malignancies.