WOBURN, Mass. — September 14, 2026
Biofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application for Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%, used with photodynamic therapy and the BF-RhodoLED® lamp series for treating superficial basal cell carcinoma (sBCC) in adults. The approval makes Ameluz the first and only FDA-approved photodynamic therapy drug for a skin cancer, while also making it the only topical PDT in the United States indicated for both actinic keratosis and a skin cancer. The new sBCC indication expands the addressable market for Biofrontera’s commercial PDT platform and provides an additional opportunity to leverage its existing product and installed lamp base. The company plans to launch the new indication from late fourth quarter 2026 through the first quarter of 2027, using its existing commercial organization and infrastructure.
Phase 3 Data Support Ameluz PDT Approval
The FDA approval is supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 study involving 187 adults with histologically confirmed sBCC. The trial’s primary endpoint required both clinical and histological complete response of a main target lesion 12 weeks after the final PDT cycle. Ameluz PDT achieved the composite endpoint in 66% of treated patients, or 95 of 145 participants, compared with 5% of patients receiving placebo-PDT. Histological clearance of the main target lesion was observed in 76% of Ameluz-treated patients versus 19% with placebo-PDT, while complete clinical clearance of all target lesions occurred in 83% and 21% of patients, respectively. The most common adverse reactions were application-site reactions, consistent with the established safety profile of Ameluz PDT. These results provide the clinical foundation for expanding the product from its existing precancerous skin indication into treatment of a common form of non-melanoma skin cancer.
Red-Light PDT Offers Non-Surgical Treatment Option
The new indication positions Ameluz and the RhodoLED platform as a non-surgical, tissue-sparing treatment option for eligible patients with superficial basal cell carcinoma. BCC is the most common skin cancer in the United States, with approximately 3.6 million cases diagnosed annually, while the superficial subtype is estimated to account for 15% to 20% of cases. Superficial lesions can occur on the trunk and extremities and may appear as multiple lesions, creating situations in which tissue-sparing approaches can be clinically relevant. Biofrontera said the sBCC approval could be particularly important for patients with multiple lesions, cosmetically sensitive lesions or circumstances where surgery is not preferred. Because the new indication uses the same Ameluz topical product and red-light device already used for actinic keratosis, existing customers can adopt the expanded treatment without requiring an entirely new platform. The company also expects the indication to encourage new dermatology practices to invest in RhodoLED systems and add Ameluz PDT to their treatment capabilities.
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Biofrontera Targets Growth Through PDT Platform Expansion
The Ameluz sBCC approval strengthens Biofrontera’s strategy of expanding the clinical and commercial utility of its photodynamic therapy platform. The company expects the new indication to create incremental growth from its existing customer base while providing a potential catalyst for expansion of its installed RhodoLED lamp network. Biofrontera is now positioned with a dermatology portfolio spanning treatment of actinic keratoses and superficial basal cell carcinoma, giving physicians a broader range of applications for the same PDT infrastructure. The company’s commercial strategy centers on using its established U.S. organization to support the planned launch while capitalizing on the operational advantages of an already-deployed device platform. With FDA approval extending Ameluz into skin cancer, Biofrontera is moving its PDT business beyond precancerous lesions and into a significantly broader medical dermatology opportunity.
Source:Biofrontera press release
