On September 14, 2026, local time, Biofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA): Ameluz (aminolevulinic acid) topical gel, 10%, in combination with the BF-Rhodo LED lamp series for photodynamic therapy for the treatment of adults with superficial basal cell carcinoma (sBCC).
Core Approval Information
The combined use of Ameluz with the Rhodo LED lamp makes it the first photodynamic therapy approved in the United States for the treatment of skin cancer, creating an additional growth opportunity for Biofrontera's photodynamic therapy platform.
Following this approval, Ameluz becomes the first PDT drug approved by the FDA for the treatment of skin cancer, and the first topical PDT in the United States simultaneously approved for the treatment of the precancerous skin lesion actinic keratosis (AK) and skin cancer.
The sBCC indication expands the addressable market for Ameluz and strengthens its position in medical dermatology. This label expansion also further advances Biofrontera's strategy to broaden the clinical utility of its red-light PDT platform.
Key Clinical Data
This approval was supported by a multicenter, randomized, double-blind, vehicle-controlled Phase III trial. The trial enrolled 187 adults with histologically confirmed sBCC. The primary endpoint was the composite endpoint of clinical and histological complete response of the primary target lesion at 12 weeks after the start of the last PDT cycle.
About Basal Cell Carcinoma (BCC)
Basal cell carcinoma is the most common skin cancer in the United States. According to data from the Skin Cancer Foundation, approximately 3.6 million cases of BCC are diagnosed annually in the United States. Published estimates show that the superficial subtype accounts for approximately 15%–20% of BCC cases, or approximately 540,000 to 720,000 sBCC cases annually in the United States². Superficial BCC lesions can reach several centimeters in diameter, are often located on the trunk and extremities, and often present as multiple lesions. For these patients, non-surgical, tissue-preserving treatment options are limited.
Expert Perspective
Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, said: "The FDA approval of Ameluz for superficial basal cell carcinoma is a defining milestone for Biofrontera. Ameluz is now the first photodynamic therapy approved in the United States for the treatment of skin cancer, which sets our platform apart in medical dermatology and gives dermatologists an effective, non-surgical option to treat this very common tumor. This approval reflects the company's years of disciplined investment in the clinical development of Ameluz and is the latest stage in the continued expansion of our PDT platform."
He added: "We plan to officially launch the sBCC indication in the late fourth quarter of 2026 to the first quarter of 2027 through our existing commercial team and installed base of lamp devices. We believe this approval will become another driver of long-term growth among existing customers. It also gives new dermatology clinics a reason to purchase the Rhodo LED lamp and begin using Ameluz PDT, thereby expanding our overall installed base."
This new indication uses the same topical product (Ameluz) and the same red-light device as the company's AK indication, so existing customers can quickly adopt this new treatment option.
About Biofrontera Inc.
Biofrontera Inc. is a U.S.-based biopharmaceutical company that commercializes a range of products for the treatment of dermatological conditions through photodynamic therapy (PDT). The company's products are used to treat actinic keratosis (a precancerous skin lesion) and superficial basal cell carcinoma, and it is developing other indications.
