Biofrontera wins FDA approval for Ameluz red-light PDT to treat superficial basal cell carcinoma
BFRI•Trial results and launch plans
Phase 3 trial showed 66% clinical-histological complete response at 12 weeks versus 5% for placebo-PDT.
Commercial launch planned for late Q4 2026 through Q1 2027 using the existing sales force and installed lamp base.
FDA approval and label expansion
Biofrontera won FDA clearance for Ameluz topical gel with RhodoLED red-light PDT to treat superficial basal cell carcinoma in adults.
Label expansion positions Ameluz as the only FDA-approved photodynamic therapy for a U.S. skin cancer indication.
