Biofrontera Inc. announced that its licensor Biofrontera Bioscience GmbH has received approval from the U.S. Food and Drug Administration (FDA) for a new formulation of Ameluz (aminolevulinic acid hydrochloride) for the treatment of actinic keratosis (AK). The new formulation is covered by the License and Supply Agreement between the two companies. The company anticip that the new formulation, which will be implemented in all U.S. Ameluz production beginning in 2024, will improve the safety profile of the topical gelby replacing propylene glycol, an ingredient common in semi-solid formulations, with ingredients already existing in Ameluz.

The improved Ameluz formulation eliminates potential risks of propylene glycol due to the ingredient exhibiting allergic potential and reacting with other components, giving rise to contaminants accumulating over time. Biofrontera Biosci has filed a patent application to protect the new formulation given that the nanoemulsion without propylene glycol constitutes a novel invention. If granted, patent protection for Ameluz could be extended until at least 2043.

The use of PDT with Ameluz (Ameluz-PDT) and RhodoLED lamps could be protected until 2040 by patents granted on the RhodoLED lamps and the associated procedure. Patent protection for Ameluz® itself currently expires in28, after which protection in the U.S. would rely on the lamp and procedure patents in the combination approval. These statements include, but are not limited to, statements relating to the effects and efficacy of the new formulation of Biofrontera Inc.'s (the "Company") licensed product Ameluz, the reduced risk of contaminants, the potential extension of patent protection for ameluz and the benefits of a new patent for Ameluz.