Biofrontera Inc. Announces Completion of Patient Enrollment in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Actinic Keratoses on the Extremities, Neck and Trunk

Core Insights - Biofrontera Inc. has completed the enrollment of the final patient in its Phase 3 clinical trial for Ameluz, aimed at treating mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk, addressing a significant unmet need in dermatology [1][3] Company Overview - Biofrontera Inc. is a biopharmaceutical company focused on developing and commercializing photodynamic therapy (PDT) for dermatological conditions, particularly through its product Ameluz, which is used in conjunction with the RhodoLED lamp series [5] Clinical Trial Details - The Phase 3 trial is a multicenter, randomized, double-blind study comparing Ameluz with a vehicle gel for treating AKs on the extremities, neck, and trunk, involving 172 patients in a 4:1 ratio [2] - Patients receive one PDT treatment and a potential second treatment at 12 weeks if lesions persist, with follow-up lasting approximately one year [2] Market Context - Actinic keratosis is the most common pre-cancerous skin lesion caused by chronic sun exposure, with around 58 million people affected in the US as of 2020, leading to 13 million treatments that year [4] Future Plans - Following the completion of the treatment phase by September 2025, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the FDA in the second half of 2026, contingent on positive trial outcomes [3]