Biofrontera Completes Final Patient Visit In Phase 1 Pharmacokinetic Study Of Ameluz Gel, 10%, For Treatment Of Mild To Moderate Actinic Keratoses On Neck, Trunk And Extremities

• Phase 1 Maximal-use Phase 1 study evaluated pharmacokinetic (PK) profile following application of 3 tubes of Ameluz® over treatment area of 240 cm2
• Completion of this study marks a key milestone towards a planned summer 2026 FDA submission for FDA approval for the use of Ameluz® on all non-face and scalp areas

WOBURN, Mass., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced the completion of the final patient visit in its Phase 1 pharmacokinetic (PK) study of Ameluz® (aminolevulinic acid hydrochloride) gel, 10%, for the treatment of mild to moderate actinic keratoses (AKs) on the neck, trunk and extremities (peripheral body areas). The last patient visit took place on 24 November 2025.

Data from this study, together with results from Biofrontera's recently completed Phase 3 clinical trial, will form the basis of a planned supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the Ameluz® label to include the treatment of AKs on all peripheral body areas. Actinic keratoses commonly occur on sun-exposed areas across the body and may progress to squamous cell carcinoma if left untreated. Expanding Ameluz®'s current FDA approval for use beyond the face and scalp would address a critical unmet need in dermatology.

This open-label Phase 1 study assessed the PK profile of 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) during Ameluz®-PDT of the upper extremities, neck or trunk using the BF-RhodoLED® XL lamp. Under maximal use conditions, three tubes of Ameluz® were applied to a treatment area of approximately 240 cm². Seventeen patients received one PDT treatment and blood samples were taken over the 10 hours following the application of Ameluz® to assess the systemic exposure to ALA and PpIX.

Pending positive outcomes of this trial and the corresponding Phase III study, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the Summer of 2026.