GlobeNewswire·Sep 14, 2026, 9:26 AM ET

Biofrontera Announces FDA Approval of Ameluz® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma

The FDA approved Biofrontera's supplemental New Drug Application for Ameluz topical gel combined with the BF-RhodoLED lamp series to treat superficial Basal Cell Carcinoma (sBCC) in adults.
Ameluz is now the first & only photodynamic therapy approved in the U.S. to treat a skin cancer & the only topical PDT indicated for both actinic keratosis & sBCC.
The approval expands the addressable market to an estimated 540,000 to 720,000 annual sBCC cases in the U.S.
Biofrontera plans an official launch of the sBCC indication between the fourth quarter of 2026 & the first quarter of 2027 using its existing commercial organization & installed lamp base.
A Phase 3 trial demonstrated a 66% composite clinical & histological complete response rate for Ameluz PDT versus 5% for placebo at 12 weeks post-treatment.
Histological clearance was achieved in 76% of Ameluz-treated patients compared to 19% for placebo, while 83% of Ameluz subjects achieved complete clinical clearance versus 21% for placebo.
The most common adverse reactions were application-site reactions consistent with the known safety profile of Ameluz PDT.
The treatment utilizes the same topical product & red-light device as the existing actinic keratosis indication, allowing rapid adoption by existing customers.