Biofrontera Inc. (NASDAQ: BFRI), a biopharmaceutical company specializing in dermatological treatments, has announced two significant milestones: the extension of U.S. patent protection for its flagship product, Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%, and the completion of patient enrollment in its Phase 2b clinical trial evaluating Ameluz® for the treatment of moderate to severe acne vulgaris.
Extended Patent Protection for Ameluz®
The U.S. Patent and Trademark Office (USPTO) has granted Biofrontera a new patent related to a photodynamic therapy (PDT) protocol that is expected to be less painful while maintaining efficacy. This patent extends the protection of Ameluz®-PDT through October 2040. Further patents are pending, which may extend protection until 2043 or beyond.
This extension fortifies Biofrontera’s intellectual property portfolio, ensuring prolonged market exclusivity for Ameluz® and its associated PDT protocols. The company anticipates that this will bolster its competitive position in the dermatological therapeutics market.
Completion of Phase 2b Acne Study Enrollment
In parallel, Biofrontera has successfully completed patient enrollment in its Phase 2b clinical trial assessing the efficacy and safety of Ameluz® for treating moderate to severe acne vulgaris. This randomized, double-blind study aims to explore the potential of Ameluz® as a novel PDT option for acne, a condition affecting millions worldwide.
The trial’s completion of enrollment marks a significant step toward expanding the indications for Ameluz®. Pending positive outcomes, Biofrontera plans to advance to Phase 3 trials, with the goal of submitting a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2026.
Strategic Outlook
These developments underscore Biofrontera’s commitment to innovation in dermatological therapies. By securing extended patent protection and advancing clinical research, the company aims to enhance its product offerings and address unmet needs in skin health.
With the extended patent life of Ameluz® and the progression of its acne treatment program, Biofrontera is poised to strengthen its market presence and deliver value to both patients and shareholders in the coming years.