Biofrontera Inc. Announces Last-Patient-Out in Phase 2b Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Moderate to Severe Acne Vulgaris

Rhea-AI Summary

Biofrontera Inc. (NASDAQ: BFRI) announced completion of patient participation in its Phase 2b clinical trial evaluating Ameluz® for treating moderate to severe acne vulgaris. The multicenter, randomized, double-blind study compared Ameluz® with vehicle gel using red-light Photodynamic Therapy (PDT), with top-line results expected in Q1 2026.

The trial involved up to 3 PDT sessions at monthly intervals, with participants receiving either 1 or 3-hour incubation before BF-RhodoLED® lamp illumination. Following anticipated positive results, Biofrontera plans FDA discussions in Q3 2026 to advance Phase 3 program for potential label expansion.

The study addresses a significant market opportunity, with acne affecting 50 million Americans annually and a market valued at $5.7 billion in 2024. Current treatments face limitations including side effects and antibiotic resistance concerns, highlighting the need for alternative solutions.

Positive

• None.

Negative

• Top-line results not expected until Q1 2026
• Phase 3 program discussions with FDA won't begin until Q3 2026
• Success in Phase 2b trial does not guarantee FDA approval
• Will compete in market dominated by established treatments (55% spending on antibiotics and isotretinoin)

Insights

Pharmaceutical Clinical Development Expert

Biofrontera reaches key milestone in acne treatment development with completed Phase 2b trial; potential market expansion awaits 2026 results.

Biofrontera's announcement represents a significant milestone in their clinical development program for Ameluz^® PDT in treating moderate to severe acne vulgaris. The completion of the last patient visit in their Phase 2b trial positions the company for potential label expansion of their existing photodynamic therapy technology into a substantial new market.

The acne treatment landscape presents a compelling opportunity, with $5.7 billion market size and 5.3% projected CAGR. More importantly, current treatment options face significant limitations - oral antibiotics raise resistance concerns, isotretinoin carries serious side effects and teratogenic risks, and many treatments require continuous daily dosing. This creates a genuine unmet need that Ameluz^® PDT could potentially address with its different mechanism of action.

The trial design appears robust - a multicenter, randomized, double-blind study comparing Ameluz^® to vehicle gel with either 1 or 3-hour incubation times before BF-RhodoLED^® lamp illumination. The protocol includes up to three monthly PDT sessions with two months of follow-up, providing a comprehensive assessment framework.

While positive results would represent just one step in a longer regulatory journey, with top-line data expected Q1 2026 and FDA discussions planned for Q3 2026, this progress demonstrates Biofrontera's strategic commitment to expanding their photodynamic therapy platform beyond its current indications. The potential to capture even a modest share of the acne market, where over 55% of spending currently goes to oral antibiotics and isotretinoin, could substantially impact Biofrontera's commercial trajectory if ultimately approved.

• Final patient visit marks key milestone for Biofrontera, with top-line results expected Q1 2026
• Company plans FDA discussion in Q3 2026 to advance Phase 3 program and potential label expansion
• More than 50 million people affected by acne in US each year, with market valued at $5.7 billion in 2024
  

WOBURN, Mass., Aug. 25, 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 in its Phase 2b clinical trial evaluating Ameluz^® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris (AV) completed participation on August 22, 2025.

Acne vulgaris is a common skin condition characterized by inflammatory and non-inflammatory lesions that frequently lead to permanent scarring. Beyond the physical burden, AV often has a significant psychological impact, including reduced self-esteem and depression.

Current U.S. guidelines recommend a range of treatment options for AV, including topical agents, systemic antibiotics, hormonal therapies, isotretinoin and physical treatments. However, many of these options carry limitations such as serious side effects, teratogenic risks, the need for continuous daily dosing, or—particularly with antibiotics—growing concerns about resistance. As a result, there remains a critical unmet need for alternative treatment options.

Biofrontera’s Phase 2b trial is a multicenter, randomized, double-blind study comparing Ameluz^® with vehicle gel for the treatment of moderate to severe acne vulgaris using red-light Photodynamic Therapy (PDT). Following application of one tube of Ameluz^® or vehicle gel to the entire face, participants were incubated for either 1 or 3 hours before illumination with the BF-RhodoLED^® lamp. Up to 3 PDT sessions were performed at monthly intervals and participants were followed up for an additional 2 months after receiving the last PDT.

“We are thrilled to achieve this important milestone in our clinical program”, said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “It brings us a significant step closer to potentially offering a new, effective and much needed treatment option for patients with moderate to severe acne vulgaris. This trial represents meaningful progress in expanding the indications for Ameluz^® and reinforces our commitment to advancing PDT.”

Dr. Mitchel P. Goldman, MD, FAAD, the coordinating investigator of the study and Medical Director of Cosmetic Laser Dermatology and Platinum Dermatology Partners, expressed optimism about its potential impact "Ameluz^® PDT has demonstrated meaningful benefits in other dermatologic conditions, and we believe it will become an important option for patients with moderate to severe acne vulgaris. Many of these patients continue to rely on regimens that carry significant treatment burdens including cost, adverse effects and the necessity for prolonged treatments. Expanding the use of Ameluz^® to treat acne would be a valuable advancement for both physicians and patients. We look forward to the study results with great anticipation.”

Biofrontera expects to receive top-line data in Q1 2026. Pending positive results, the Company intends to present the findings to the U.S. Food Drug Administration (FDA) in early Q3 2026 as the basis for a future Phase III program, with the goal of achieving approval for Ameluz^® PDT for the treatment of acne vulgaris.

About Acne Vulgaris

Acne vulgaris is the most common skin condition in the United States, affecting an estimated 50 million people each year^¹. Although often associated with adolescence, it persists into adulthood, impacting approximately 40% of adults^². The condition ranges from mild blackheads and whiteheads to severe inflammatory forms such as nodules and cysts, which can cause permanent scarring and have profound effects on mental health and self-esteem^³. Current U.S. guidelines recommend topical therapies, oral antibiotics, and isotretinoin for moderate to severe acne^⁴. However, these treatments are frequently limited by significant systemic side effects, driving demand for safer and more effective alternatives. The U.S. acne treatment market, valued at $5.7 billion in 2024 and projected to grow at a 5.3% CAGR, reflects this unmet need^⁵. More than 55% of spending is currently directed to oral antibiotics and isotretinoin^⁶, underscoring the reliance on systemic therapies and the opportunity for novel treatment approaches.

About Biofrontera Inc.

Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the development and 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 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.

Contacts:

Investor Relations
Andrew Barwicki
1-516-662-9461
ir@bfri.com

References:

1. American Academy of Dermatology Association. Acne: Overview. https://www.aad.org/public/diseases/acne
2. Collier CN et al. “The prevalence of acne in adults 20 years and older.” J Am Acad Dermatol. 2008;58(1):56–59.
3. Tan JK, Bhate K. “A global perspective on the epidemiology of acne.” Br J Dermatol. 2015;172 Suppl 1:3–12.
4. Zaenglein AL et al. “Guidelines of care for the management of acne vulgaris.” J Am Acad Dermatol. 2016;74(5):945–973.e33.
5. Fortune Business Insights. Acne Treatment Market Size, Share & Trends Report, 2024–2032 . https://www.fortunebusinessinsights.com/acne-treatment-market-102596
6. IQVIA Institute Report, U.S. Dermatology Market Analysis, 2023

FAQ

What are the key findings from Biofrontera's (BFRI) Phase 2b acne treatment trial?

The trial has completed patient participation, but top-line results won't be available until Q1 2026. The study evaluated Ameluz® with PDT for moderate to severe acne vulgaris, involving up to 3 PDT sessions at monthly intervals.

How large is the market opportunity for Biofrontera's (BFRI) acne treatment?

The US acne treatment market is valued at $5.7 billion as of 2024, with a 5.3% CAGR. The condition affects approximately 50 million Americans annually, including 40% of adults.

What is the timeline for Biofrontera's (BFRI) Ameluz FDA approval for acne?

Biofrontera expects top-line data in Q1 2026 and plans FDA discussions in Q3 2026 to advance the Phase 3 program. The exact timeline for potential FDA approval will depend on these discussions and Phase 3 results.

How does Biofrontera's (BFRI) Ameluz treatment differ from current acne therapies?

Ameluz® uses Photodynamic Therapy (PDT) with red-light illumination, offering a potential alternative to current treatments like antibiotics and isotretinoin that often have significant side effects and treatment burdens.

What are the current limitations of existing acne treatments that Biofrontera (BFRI) aims to address?

Current treatments face challenges including serious side effects, teratogenic risks, daily dosing requirements, and growing antibiotic resistance concerns. Over 55% of spending goes to oral antibiotics and isotretinoin.