Biofrontera Inc. Announces New Patent Protection on Ameluz® until 2043 and the Completion of Patient Enrollment in Phase 2b Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Moderate to Severe Acne Vulgaris

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Biofrontera Inc.
Biofrontera Inc.
  • Biofrontera has received patent approval for the revised formulation of Ameluz®, which extends patent protection through to December 2043

  • Ameluz PDT offers the potential for effective treatment of moderate to severe acne without the side effects associated with some systemic therapies4

  • Approximately 50 million people in the US are suffering from acne vulgaris, including both adolescents and adults1,2

  • The US acne treatment market was valued at $5.7 billion in 2024 and is growing annually5

WOBURN, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), received confirmation that the updated formulation of the Ameluz® nanoemulsion gel without propylene glycol received patent approval through to December 2043. The formulation was earlier accepted for use in Ameluz® by the US Food and Drug Administration (FDA) and is in use since 2024. In addition to this long-lasting protection of Ameluz® against generic competition, Biofrontera today announced the successful enrollment of the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris.

The multicenter, randomized, double-blind study is designed to assess the safety and efficacy of PDT with the BF-RhodoLED® lamp and Ameluz® or vehicle gel after two different incubation periods —1 hour and 3 hours. One tube of Ameluz® or vehicle gel is applied to the entire face, followed by illumination for 10 minutes after the specified incubation period has taken place.

Patients received up to three PDT sessions spaced one month apart and will receive follow-up consultations for two months following their final treatment. A total of 120 patients has been enrolled. The Company anticipates last-patient-out in Q3 2025, marking a key milestone in the clinical development of Ameluz® for a potential new dermatological indication.

Dr. Mitchel P. Goldman, MD, FAAD, the coordinating investigator of the study and Medical Director of Cosmetic Laser Dermatology and Platinum Dermatology Partners, expressed enthusiasm about its potential impact. “We see many patients who suffer from inflammatory acne. The possibility of expanding the indication for Ameluz® PDT to treat this disorder would be welcomed by physicians and our patients. I look forward to seeing the final results of the study.”

The U.S. acne treatment market was valued at approximately $5.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 5.3%, driven by rising adult prevalence of acne and demand for advanced therapies5. Notably, over 55% of total market spending is attributed to oral antibiotics and isotretinoin, the primary treatments for moderate to severe inflammatory acne6. These therapies, while effective, are often associated with systemic side effects, underscoring the need for alternative treatment options.