The FDA has accepted Biofrontera’s application to expand the use of Ameluz (aminolevulinic acid) topical gel, used with the RhodoLED red light device, to treat superficial basal cell carcinoma (BCC). The agency found no problems with the filing and set a decision date of September 28, 2026.
If approved, Ameluz would become the first photodynamic therapy (PDT) specifically indicated for superficial BCC in the United States. The drug is currently approved only for actinic keratosis. Superficial BCC makes up about 10% to 25% of the 3.6 million BCC cases diagnosed each year in the U.S. This treatment could offer a non-surgical alternative to standard destructive procedures.
Ameluz uses nanoemulsion technology and red light to help the medication penetrate deeper into the skin compared with blue or green light therapies.
In a phase 3 trial involving 187 patients, the treatment showed significantly better results than a vehicle control. Composite clearance was achieved in 65.5% of patients treated with Ameluz, compared with 4.8% in the control group. Histological clearance was 75.9% versus 19.0%, and clinical clearance was 83.4% versus 21.4%. All differences were statistically significant.
Most patients (88.1%) rated the cosmetic results as good or very good. No new safety concerns were identified. The most common side effects were pain at the application site (95.2%), redness (69%), and itching (50.3%).