FDA accepts supplemental new drug application for Ameluz PDT (aminolevulinic acid hydrochloride) in superficial basal cell carcinoma – Biofrontera

Biofrontera Inc. announced that the FDA has completed its filing review and accepted filing of the Company’s supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel used in combination with the RhodoLED red-light lamp series for the treatment of sBCC. The FDA identified no filing deficiencies and assigned a PDUFA target action date of 28 September 2026.

If approved, this new indication would represent a significant clinical expansion of the Ameluz PDT platform beyond its existing FDA approval for treatment of actinic keratosis. It would also further validate Biofrontera’s PDT approach, which combines Ameluz’s nanoemulsion technology with red-light illumination designed to penetrate deeper into tissue compared with shorter wavelengths of light such as green and blue, enabling treatment of lesions extending into deeper skin layers.

Basal cell carcinoma is the most common cancer in the U.S., with approximately 3.6 million cases diagnosed annually, and published estimates suggest that 10–25% of these cases are of the superficial subtype. Current treatment options often rely on surgical or destructive approaches, which may not be appropriate or preferred for all patients.

“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,” said Dr. Hermann Luebbert, Chief Executive Officer of Biofrontera. “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.”

If approved, Ameluz PDT for the treatment of sBCC would offer dermatology providers and their patients a non-invasive treatment option aligned with real-world practice needs. Biofrontera believes this indication has the potential to meaningfully expand the addressable market for Ameluz and strengthen the Company’s position in medical dermatology.