Biofrontera secures FDA approval for 10% Ameluz gel
- Biofrontera received U.S. FDA approval for its Ameluz 10% topical gel to treat superficial basal cell carcinoma in adult patients.
- The regulatory decision expands the addressable market for the company by making the product the only photodynamic therapy currently approved for this specific skin cancer in the United States.
- The company stated it expects to officially launch the newly approved indication between late 2026 and early 2027 using its existing commercial infrastructure.
Biofrontera (NASDAQ:BFRI) received U.S. FDA approval of a supplemental New Drug Application for its Ameluz 10% topical gel and BF-RhodoLED lamp to treat adult patients with superficial basal cell carcinoma.
The regulatory decision expands the addressable market for the treatment, establishing the product as the only topical photodynamic therapy in the United States indicated for both actinic keratosis and superficial basal cell carcinoma.
The approval was supported by a 187-patient Phase 3 trial where 66% of patients receiving the active treatment achieved a complete clinical and histological response at 12 weeks, compared to 5% in the placebo group.
The clinical data also demonstrated histological clearance in 76% of treated patients and complete clinical clearance of all target lesions in 83%, alongside expected application-site adverse reactions.
The company stated that it plans to initiate the official commercial launch of the new indication between the fourth quarter of 2026 and the first quarter of 2027 by leveraging its installed base of therapeutic lamps.
