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
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.
“We are thrilled to reach this pivotal stage in our clinical program,” said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “The successful enrollment of our last patient in this important Phase 2b study brings us closer to offering an effective treatment option for patients with moderate to severe acne. It marks a significant step in expanding the indications for Ameluz® PDT over and above the currently approved treatment of mild to moderate actinic keratosis on the face and scalp. Together with our patent protection now lasting to December 2043, extensions of the Ameluz approved indications position our company for future growth.”
About Acne vulgaris
Acne vulgaris is the most common skin condition in the United States, affecting an estimated 50 million people annually1. While often associated with adolescence, studies have shown that acne affects approximately 40% of the adult population2. It can range from mild (blackheads and whiteheads) to more severe forms, including inflammatory pimples, nodules, and cysts. If not treated effectively, acne may lead to permanent scarring and can significantly affect a person’s mental health and self-esteem3.
According to U.S. clinical guidelines, treatment options for moderate to severe inflammatory acne include topical therapies, oral antibiotics, and isotretinoin which may have serious side effects4. As a result, there is a growing need for effective alternatives.
IQVIA Institute Report, U.S. Dermatology Market Analysis, 2023. (Note: Replace with actual IQVIA data if available or request specific spending data from your market access team.)
About Biofrontera Inc.
Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and Twitter.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the impact of any extraordinary external events; any changes in the Company’s relationship with its licensors; the ability of the Company’s licensors to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company’s ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s licensed products; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company’s expectations; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.
Contact: Investor Relations Andrew Barwicki 1-516-662-9461 ir@bfri.com
