Biofrontera Inc. completes enrollment for Phase 3 study of Ameluz®

From GlobeNewswire: 2025-03-18 09:30:00

Biofrontera Inc. completes Phase 3 study for Ameluz® in treating actinic keratoses on extremities, neck, and trunk. Trial involves one or two PDT treatments with up to 3 tubes of product. Study enrolled 172 patients and is expected to be completed by Q3 2025. If successful, Biofrontera plans to submit sNDA in 2026. Actinic keratosis affects 58 million Americans and can lead to squamous cell carcinoma if untreated. Results could expand treatment options beyond face and scalp. Positive outcomes may lead to FDA approval for new indications. Study could offer promising treatment options for patients with AKs.



Read more at GlobeNewswire: Biofrontera Inc. Announces Completion of Patient Enrollment