Biofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Photodynamic Therapy (PDT) for the Treatment of Actinic Keratoses (AK) on the Extremities, Neck and Trunk

• All 172 patients have now entered the 12-month follow-up phase
• Trial involves larger surface areas, building on the approval in October 2024 for use of up to 3 tubes of Ameluz^® per treatment
• Study results expected to form the basis of a supplemental New Drug Application (sNDA) planned for submission in Q2 2026

WOBURN, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced that the final patient completed the active treatment phase of its Phase 3 clinical trial evaluating Ameluz^® (10% 5-aminolevulinic acid hydrochloride gel) PDT for mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk on September 3, 2025. All 172 enrolled patients have now entered the 12-month follow-up phase, expected to conclude in Q2 2026.

Actinic keratosis is a common precancerous skin condition found on sun-exposed areas of the body: 58 million US adults have at least one AK lesion¹. If left untreated these may progress to cutaneous squamous cell carcinomas, with more than 70% originating from AK lesions². Expanding treatment options for AKs beyond the face and scalp would therefore address a critical unmet need in dermatology.

This Phase 3 study is a multicenter, randomized, double-blind trial designed to evaluate the safety and efficacy of Ameluz^® PDT versus vehicle gel in the treatment of actinic keratoses (AKs) on the extremities, neck and trunk. PDT was administered using a RhodoLED^® or BF-RhodoLED^® XL lamp following application of one to three tubes of either Ameluz^® or vehicle to areas of approximately 80, 160 or 240 cm². Patients received a single PDT treatment, with a second one at 12 weeks if residual lesions remained. They are now being followed for 12 months to assess recurrence and new lesion development. In total, 172 subjects were enrolled in the study.

“We are delighted to reach this stage in our clinical program,” said Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “Building on the recent FDA approval for the use of up to 3 tubes of Ameluz^® per treatment, today’s milestone marks another step in broadening the label and market potential for this product. Together, these developments reflect Biofrontera’s strategic progress toward leadership in PDT.”

Dr. Nathalie Zeitouni, Mohs surgeon and clinical investigator at Medical Dermatology Specialists, Professor of Dermatology at the University of Arizona COM Phoenix and the coordinating investigator in the study, expressed enthusiasm about its’ potential impact. “We frequently see people with AKs on the trunk and extremities, and current treatment options are limited. Expanding the use of Ameluz^® PDT to these areas would be a welcome advancement for dermatologists and our patients.”

The 12-month follow-up phase is expected to be completed by Q2 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) that same quarter.

About Actinic Keratosis

AK is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp, arms or the back of the hands. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed.¹

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 X.

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 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; 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; 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
Ben Shamsian, Lytham Partners
+1-646-829-9701
ir@bfri.com

References
1. Skin Cancer Foundation Actinic Keratosis Overview. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/#:~:text=Actinic%20keratosis%20(AK)%20is%20the,to%20ultraviolet%20(UV)%20radiation
2. Thomson et al, Br J Derm, 189 (1): July 2023; e4–e5

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