Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series

Sept. 14, 2026: Biofrontera Inc. (NASDAQ: BFRI) said the FDA approved its supplemental NDA for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, used with the BF-RhodoLED lamp series, to treat superficial basal cell carcinoma (sBCC) in adults. The company said Ameluz is now the first and only photodynamic therapy approved in the U.S. for a skin cancer, and the only topical PDT indicated for both actinic keratosis and sBCC.

The approval was supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial in 187 adults with histologically confirmed sBCC. The primary endpoint, a composite of clinical and histological complete response of the main target lesion 12 weeks after the start of the last PDT cycle, was achieved in 66% of Ameluz-PDT patients (95/145) versus 5% for placebo-PDT (2/42). Histological clearance of the main target lesion was 76% versus 19%, and complete clinical clearance of all target lesions was 83% versus 21%, respectively. The most common adverse reactions were application-site reactions consistent with the known Ameluz PDT safety profile.

Biofrontera plans an official launch of the sBCC indication in late 4Q 2026 through 1Q 2027.