Biofrontera: FDA approves Ameluz for superficial basal cell carcinoma

FDA approved the sNDA for Ameluz plus BF-RhodoLED red-light PDT for superficial basal cell carcinoma in adults. This makes Ameluz the first and only PDT approved in the US for a skin cancer and the only topical PDT indicated for both actinic keratosis and a skin cancer. The label expansion uses the same product and device already marketed for AK, enabling immediate commercial use.

Key facts

Filed: Sep 14, 2026, 01:29 PM
Event: FDA approval
Direction: Positive
Company: BFRIBiofrontera Inc.
Asset: Ameluz
Source: SEC 8-K
Confidence: Sourced
Calendar: FDA decision (PDUFA) · Sep 28, 2026 · Approved
clinical clearance: 83% vs 21%
annual us sbcc cases: 540,000 to 720,000
phase 3 response rate: 66% vs 5%
histological clearance: 76% vs 19%

Source excerpt

EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Biofrontera Announces FDA Approval of Ameluz ® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma Ameluz used in conjunction with the RhodoLED lamp becomes the first and only photodynamic therapy approved in the United States to treat a skin cancer, creating an additional growth opportunity for Biofrontera’s photodynamic therapy platform WOBURN, Mass., September 14, 2026 — Biofrontera Inc. (NASDAQ: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Ameluz ® (aminolevulinic acid hydrochloride) topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED ® lamp series, for the treatment of superficial Basal Cell Carcinoma (sBCC) in adults 1 . With this approval, Ameluz becomes the first and only PDT drug approved by the FDA for the treatment of a skin cancer, and the only topical PDT in the United States indicated to treat both a pre-cancerous skin condition, actinic keratosis (AK), and a skin cancer. The sBCC indication expands the addressable market for Ameluz and strengthens its position in medical dermatology. This label expansion also furthers Biofrontera’s strategy of broadening the clinical utility of its Red-Light PDT platform. Hermann Lu

SEC 8-K