Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT

Rhea-AI Summary

Biofrontera (Nasdaq: BFRI) submitted a supplemental New Drug Application (sNDA) to the U.S. FDA on November 28, 2025 seeking approval of Ameluz®-PDT for treatment of superficial basal cell carcinoma (sBCC).

The submission includes full Phase 3 treatment and one-year follow-up data from a randomized, double-blind, placebo-controlled U.S. study of 187 patients. Primary endpoint: 65.5% clearance with Ameluz®-PDT vs 4.8% with placebo (p<0.0001). Key secondary endpoints showed histological clearance 75.9%, clinical clearance 83.4%, and total lesion clearance 64.1% with low one-year recurrence and high patient satisfaction.

Positive

• sNDA submitted to FDA on Nov 28, 2025
• Primary endpoint: 65.5% clearance vs 4.8% (p<0.0001)
• Histological clearance 75.9% and clinical clearance 83.4%
• One-year follow-up showed low recurrence and strong aesthetics
• 85.5% patient satisfaction rated good or very good

Negative

• Regulatory outcome uncertain—sNDA approval is pending
• U.S. Phase 3 represents a single trial of 187 patients

Insights

Clinical and Regulatory Strategist

Phase 3 sNDA submission with highly significant efficacy and one-year durability, potentially expanding Ameluz® into sBCC.

The Phase 3 randomized, double-blind study enrolled 187 patients and met its primary composite endpoint with a 65.5% clearance rate versus 4.8% for placebo (p<0.0001). Key secondary endpoints showed 75.9% histological clearance and 83.4% clinical clearance for the preselected lesion, and total lesion clearance of 64.1%; patient satisfaction was high at 85.5%.

Regulatory impact depends on the FDA review of the submission filed on Nov 28, 2025 and on the integrated safety assessment combining U.S. and European data. The one-year follow-up with low recurrence and preserved aesthetics strengthens a durable-benefit case, but final labeling and any risk-mitigation language remain subject to agency review.

Concrete items to watch include the FDA review milestones and any requests for additional data or CMC clarifications; expect updates tied to the submission timeline beginning after Nov 28, 2025.

• sNDA for treatment of sBCC with Ameluz^®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025
• First Phase 3 PDT study in patients with sBCC in the United States submitted to FDA
• Primary and key secondary endpoints met with high statistical significance (p <0.0001)
• Favorable recurrence outcomes at one-year follow-up
• BCC is the most common skin cancer in the US with more than 3 million cases diagnosed annually¹
  

WOBURN, Mass., Dec. 02, 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 the submission of an sNDA to the FDA, seeking approval of Ameluz^®-PDT for the treatment of sBCC.

The submission includes the full efficacy data sets from the Phase 3 treatment phase and the one-year follow-up, together with an integrated safety assessment combining data from Biofrontera’s U.S. and European Basal Cell Carcinoma clinical studies. The filing seeks to expand the Ameluz^® label to include treatment of sBCC treatment with PDT using its BF-RhodoLED^® or RhodoLED^® XL red light lamps.

The double-blind, randomized, placebo-controlled, multi-center Phase 3 study evaluated the safety and efficacy of Ameluz^®-PDT in 187 patients with one or more clinically and histologically confirmed superficial BCCs. Participants received one cycle of two PDT treatments (either Ameluz^®-PDT or placebo-PDT) 1-2 weeks apart. If required, a second treatment cycle was repeated at three months.

The study’s primary endpoint was a composite measure of complete clinical and histological clearance of one preselected “main target lesion” (MTL) at 12 weeks after the start of the last PDT cycle. This rigorous target was achieved with a 65.5% clearance rate in the Ameluz^®-PDT arm (95/145 subjects) compared to 4.8% in the placebo-PDT arm (2/42 subjects), a highly significant statistical difference (p<0.0001).

Key secondary endpoints demonstrated even higher efficacy with (i) complete histological clearance of the MTL seen in 75.9% (110/145) of patients with Ameluz^® compared to 19.0% (8/42) with placebo, (ii) complete clinical clearance of the MTL achieved in 83.4% (121/145) of patients treated with Ameluz^® compared to 21.4% (8/42) with placebo, and (iii) total clearance of all sBCC lesions in 64.1% of subjects treated with Ameluz compared to 4.8% with placebo (p<0.0001 for all endpoints).

Patient reported outcomes also supported these findings, with a large majority of them – 85.5% – rating the overall treatment satisfaction and aesthetic outcome with Ameluz^®-PDT as very good or good. One-year follow-up data further reinforced the durability of response and the long-term cosmetic advantages of Ameluz^®-PDT, demonstrating low recurrence rates and excellent aesthetic outcomes.

“We are delighted that these highly significant results align with those found in the European studies and that we were able to submit this data package to FDA and seek an extension of the label to include sBCC,” stated Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “If approved, this would expand the Ameluz^® indication to cutaneous oncology and would represent a significant milestone in our mission to become market leaders in the field of PDT.”

Dr. Todd Schlesinger, board certified dermatologist and Mohs surgeon, Director of the Clinical Research Center of the Carolinas in Charleston, South Carolina, and first author of the recent publication of the Phase 3 results in the Journal of the American Academy of Dermatology (JAAD)² summarized “The efficacy, tolerability, and aesthetic outcomes demonstrated in the Phase 3 study and highlighted in our publication reinforce the value of Ameluz^®-PDT for the treatment of sBCC. I look forward to potentially having this as an approved option for my patients with sBCC”.

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.³

1. https://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma/
2. https://www.jaad.org/article/S0190-9622(25)02656-8/fulltext
3. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/ 

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 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; the ability of the Company’s manufacturing partners to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether any global disruptions in supply chains will impact the Company’s ability to obtain and distribute its products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s 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. 

Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com

FAQ

What did Biofrontera (BFRI) file with the FDA on November 28, 2025?

Biofrontera filed an sNDA seeking approval of Ameluz®-PDT for superficial basal cell carcinoma.

What were the Phase 3 primary endpoint results for Ameluz®-PDT in sBCC (BFRI)?

Primary endpoint: 65.5% clearance in Ameluz®-PDT vs 4.8% with placebo (p<0.0001).

How many patients were in the U.S. Phase 3 sBCC study for Ameluz®-PDT (BFRI)?

The double-blind, randomized U.S. Phase 3 study enrolled 187 patients.

What did one-year follow-up show for Ameluz®-PDT in the BFRI Phase 3 study?

One-year data showed low recurrence rates and favorable long-term cosmetic outcomes.

Which light sources were included in Biofrontera’s sNDA for Ameluz®-PDT (BFRI)?

The filing seeks label expansion to include PDT with BF-RhodoLED or RhodoLED XL red light lamps.