Pharma powerhouse Biofrontera has announced a major regulatory milestone as the US FDA accepted its supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel combined with the RhodoLED red-light lamp to treat superficial basal cell carcinoma (sBCC).

 

If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US, expanding its existing indication for actinic keratosis and offering a non-invasive alternative to traditional surgical treatments. Basal cell carcinoma is the most common skin cancer in the country, with 3.6 million cases diagnosed annually, 10–25% of which are superficial.

 

Dr. Hermann Luebbert, CEO of Biofrontera, highlighted the significance of the milestone: “We are proud of the investments we continue to make in this specialty. This milestone represents an important step forward in our strategy to expand the clinical utility of Ameluz and reinforce photodynamic therapy as a versatile platform in dermatology.”

 

He added: “The FDA’s acknowledgement of no filing deficiencies in our sNDA reflects the strength of the data package and allows us to move forward with confidence toward a potential new indication that addresses a meaningful unmet medical need.”

 

Biofrontera’s PDT approach combines nanoemulsion technology with deep-penetrating red light, enabling treatment of lesions extending into deeper skin layers—an innovation that could redefine standard care for sBCC patients.

 

If approved, the new indication would provide dermatologists and patients a non-invasive treatment aligned with real-world practice needs, potentially expanding the market for Ameluz and strengthening Biofrontera’s position in medical dermatology.