FDA approves Biofrontera's Ameluz PDT for superficial basal cell carcinoma; launch expected Q4 2026–Q1 2027

Biofrontera Inc.

FDA approved sNDA for Ameluz (aminolevulinic acid) topical gel 10% + BF-RhodoLED lamp for sBCC in adults; first US PDT approved for skin cancer.
Phase 3 trial (187 adults): composite complete response 66% (95/145) with Ameluz PDT vs 5% (2/42) placebo; histological clearance 76% vs 19%.
Estimated US market: 540,000–720,000 sBCC cases/yr (approx. 15–20% of 3.6M BCC cases); existing AK indication retained.
Commercial launch of sBCC indication planned late Q4 2026 through Q1 2027 using existing commercial organization and installed lamp base.
CEO Hermann Luebbert calls approval a defining milestone; expands addressable market and strengthens PDT platform.

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