Biofrontera Inc. announces patent protection on Ameluz until 2043

Biofrontera received confirmation that the updated formulation of the Ameluz nanoemulsion gel without propylene glycol received patent approval through to December 2043. The formulation was earlier accepted for use in Ameluz by the US Food and Drug Administration and is in use since 2024. In addition to this long-lasting protection of Ameluz against generic competition, Biofrontera announced the enrollment of the final patient in its Phase 2b clinical trial evaluating Ameluz for the treatment of moderate to severe acne vulgaris. The multicenter, randomized, double-blind study is designed to assess the safety and efficacy of PDT with the BF-RhodoLED lamp and Ameluz or vehicle gel after two different incubation periods -1 hour and 3 hours. One tube of Ameluz or vehicle gel is applied to the entire face, followed by illumination for 10 minutes after the specified incubation period has taken place. Patients received up to three PDT sessions spaced one month apart and will receive follow-up consultations for two months following their final treatment. A total of 120 patients has been enrolled. The Company anticipates last-patient-out in Q3 2025, marking a key milestone in the clinical development of Ameluz for a potential new dermatological indication.