Biofrontera Announces Results From 172 Participants In Its Phase 3 Cliical Study Of Ameluz Photodynamic Therapy To Treat Actinic Keratoses

Biofrontera Inc. (Nasdaq: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz® PDT with the red-light LED (RhodoLED®) platform for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk.

The multicenter, randomized, double-blind, vehicle-controlled Phase 3 study evaluated the efficacy and tolerability of field-directed Ameluz® PDT compared with vehicle PDT in patients with AKs located on the extremities, neck, and trunk. The study enrolled 172 patients, randomized 4:1 to receive Ameluz® gel or vehicle gel, respectively.

The study was designed to assess treatment of increasing field sizes through the application of one, two, or three tubes of Ameluz® over areas of approximately 80, 160, or 240 cm², applied either continuously or in patches, followed by PDT using a RhodoLED® XL or BF-RhodoLED® lamp. Patients received one PDT treatment, with a second PDT treatment administered at Week 12 if any AK lesions remained. Patients are being followed for approximately one year after their final PDT treatment.