Biofrontera Inc. announced the launch of a randomized, double- blind, vehicle-controlled, multicenter Phase 3 clinical study to evaluate the safety and efficacy of Ameluz(R) and BF- RhodoLED(R) XL in the field-directed treatment of actinic keratosis (AK) on the extremities, neck and trunk. The study is being managed by Biofrontera Bioscience GmbH. This past weekend Biofrontera held an Investigator Meeting to train clinical investigators on the protocol for this photodynamic therapy (PDT) study and prepare for site initiation.

Initially 11 clinical trial sites in the U.S. will participate, enrolling approximately 165 patients stratified by body region. This study will utilize Biofrontera's new RhodoLED(R) XL, a red-light lamp approved by the U.S. Food and Drug Administration (FDA) for use in PDT in combination with Ameluz(R) (Ameluz(R) -PDT) for the treatment of mild-to-moderate actinic keratosis. This lamp allows for the illumination of a larger surface area, thereby enabling simultaneous treatment of AK lesions that are distant from one another.

"This Phase 3 clinical study supports strategy to gain market share by expanding the label for Ameluz(R) -PDT beyond the treatment of AK on the face and scalp. Ameluz(R) and the BF-RhodoLED(R) lamps, through Biofrontera Inc.'s license and supply agreement with Biofrontera AG, are also undergoing clinical testing in three additional indications: Phase 3 3 clinical study in the U.S. evaluating Ameluz(R)-PDT utilizing the BF-RhodoLED(R) lamp for the treatment of superficial basal cell carcinoma. A multicenter, randomized, double-blind Phase 2 clinical study evaluating the efficacy of Ameluz(R)-PDT for the treatment of moderate-to-severe acne.

An open-label, multicenter Phase 1 clinical study evaluating the safety and tolerability of Ameluz-PDT for the treatment of AK located on the face and scalp utilizing the BF-RhodoLED(R) XL lamp and three tubes of Ameluz(R).