On September 14, 2026, Biofrontera Inc. (NASDAQ: BFRI) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%. The approval authorizes the use of Ameluz in combination with photodynamic therapy using the BF-RhodoLED lamp series for the treatment of superficial basal cell carcinoma (sBCC) in adults.
According to the filing, Ameluz is now the first and only photodynamic therapy (PDT) approved by the FDA to treat a skin cancer. It is also the only topical PDT in the United States indicated to treat both a pre-cancerous condition, actinic keratosis, and a skin cancer. The company stated that this label expansion creates an additional growth opportunity for its photodynamic therapy platform.
Biofrontera plans to launch the new sBCC indication late in the fourth quarter of 2026 through the first quarter of 2027 using its existing commercial organization and installed lamp base. The company noted that the new indication utilizes the same topical product and red-light device as its existing actinic keratosis indication.
The approval is supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial involving 187 adults with histologically confirmed sBCC. The primary endpoint was a composite of both clinical and histological complete response of a main target lesion 12 weeks after the start of the last photodynamic therapy cycle. The trial results showed that 66% of subjects treated with Ameluz PDT achieved this primary endpoint, compared to 5% of subjects treated with placebo-PDT. Histological clearance of the main target lesion was seen in 76% of Ameluz PDT treated patients versus 19% with Placebo-PDT.
Biofrontera noted that basal cell carcinoma is the most common skin cancer in the United States, with approximately 3.6 million cases diagnosed annually. The superficial subtype accounts for an estimated 540,000 to 720,000 sBCC cases annually in the U.S.
