Biofrontera gets FDA OK for Ameluz skin cancer use
FDA approval of Ameluz for superficial basal cell carcinoma expands Biofrontera’s PDT label and creates a new U.S. market opportunity.
Rhea-AI Filing Summary
Biofrontera Inc. (BFRI) reports that the U.S. Food and Drug Administration has approved its supplemental New Drug Application for Ameluz topical gel, 10%, used with the BF‑RhodoLED lamp series for treatment of superficial basal cell carcinoma (sBCC) in adults. Ameluz is now the first and only photodynamic therapy approved in the United States to treat a skin cancer and the only topical PDT indicated for both actinic keratosis and a skin cancer.
The company states that this new sBCC indication broadens Ameluz’s addressable market and supports its strategy to expand its red‑light PDT platform. In a Phase 3 trial of 187 adults with sBCC, complete clinical and histological response of the main target lesion at 12 weeks was achieved in 66% of Ameluz PDT patients versus 5% with placebo PDT. Biofrontera plans an official launch of the sBCC indication in late fourth quarter 2026 through first quarter 2027 using its existing commercial organization and installed lamp base.
Positive
- FDA approval of Ameluz for superficial basal cell carcinoma provides Biofrontera with a new, cancer-treatment indication and strengthens its dermatology franchise.
- Ameluz becomes the first and only photodynamic therapy approved in the U.S. to treat a skin cancer, potentially differentiating Biofrontera’s PDT platform.
- The new indication targets an estimated 540,000–720,000 superficial BCC cases annually in the United States, materially expanding the potential patient pool.
- Phase 3 data showed a 66% composite complete response with Ameluz PDT versus 5% with placebo PDT, supporting the clinical robustness of the label expansion.
Negative
- None.
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8-K Event Classification
Key Figures
Key Terms
supplemental New Drug Application regulatory
photodynamic therapy medical
superficial basal cell carcinoma medical
actinic keratosis medical
histological complete response medical
vehicle-controlled Phase 3 trial medical
FAQ
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What did Biofrontera Inc. (BFRI) announce regarding Ameluz?
Why is this FDA approval significant for BFRI?
How large is the potential U.S. market for superficial basal cell carcinoma?
What key Phase 3 trial results support the new Ameluz indication?
When does Biofrontera plan to launch the new sBCC indication for Ameluz?
Will existing Ameluz customers need new equipment for the sBCC indication?
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
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Item 8.01 Other Events.
On September 14, 2026, Biofrontera Inc. (the “Company”) issued a press release announcing that it has received notification from the U.S. Food and Drug Administration (the “FDA”) that the FDA had approved the Company’s supplemental New Drug Application for Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED® lamp series, for the treatment of superficial basal cell carcinoma in adults. A copy of the press release is being furnished as Exhibit 99.1 attached to this Current Report on Form 8-K.
The information contained in Item 8.01 of this Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing by the company under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
| 99.1 | Press release of Biofrontera Inc. dated September 14, 2026 | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| September 14, 2026 | Biofrontera Inc. |
| (Date) | (Registrant) |
| /s/ E. Fred Leffler III | |
| E. Fred Leffler, III | |
| Chief Financial Officer |
Exhibit 99.1
Biofrontera Announces FDA Approval of Ameluz® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma
Ameluz used in conjunction with the RhodoLED lamp becomes the first and only photodynamic therapy approved in the United States to treat a skin cancer, creating an additional growth opportunity for Biofrontera’s photodynamic therapy platform
WOBURN, Mass., September 14, 2026 — Biofrontera Inc. (NASDAQ: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED® lamp series, for the treatment of superficial Basal Cell Carcinoma (sBCC) in adults1.
With this approval, Ameluz becomes the first and only PDT drug approved by the FDA for the treatment of a skin cancer, and the only topical PDT in the United States indicated to treat both a pre-cancerous skin condition, actinic keratosis (AK), and a skin cancer. The sBCC indication expands the addressable market for Ameluz and strengthens its position in medical dermatology. This label expansion also furthers Biofrontera’s strategy of broadening the clinical utility of its Red-Light PDT platform. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, stated: “FDA approval of Ameluz for superficial basal cell carcinoma is a defining milestone for Biofrontera. Ameluz is now the first and only photodynamic therapy approved in the United States to treat a skin cancer, which sets our platform apart in medical dermatology and gives dermatologists an effective, non-surgical option for a very common tumor. This approval reflects years of disciplined investment in the clinical development of Ameluz, and the latest stage in the ongoing expansion of our PDT platform.” He added “We are planning an official launch of the sBCC indication late in the fourth quarter of 2026 through the first quarter of 2027 with our existing commercial organization and installed lamp base. We believe the approval represents a further driver of long-term growth for our existing customers. It also gives new Dermatology practices a reason to purchase a RhodoLED lamp and begin to use Ameluz PDT, expanding our overall installed base.” This new indication utilizes the same topical product (Ameluz) and the same red-light device as the Company’s AK indication, so our existing customers will be able to rapidly adopt this new treatment option.
Basal cell carcinoma (BCC) is the most common skin cancer in the United States, with approximately 3.6 million cases diagnosed annually, according to the Skin Cancer Foundation. Published estimates suggest that the superficial subtype accounts for approximately 15%-20% of BCC cases, or an estimated 540,000 to 720,000 sBCC cases annually in the U.S.2. Superficial BCC lesions can be up to several cm in diameter and are frequently located on the trunk and extremities and often present as multiple lesions, for which non-surgical, tissue-sparing treatment options are limited.
The
approval is supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial in 187 adults with histologically
confirmed sBCC. The primary endpoint was a composite of both clinical and histological complete response of a main target lesion 12 weeks
after the start of the last PDT cycle. This rigorous target was achieved in 66% of subjects treated with Ameluz PDT (95/145) compared
with 5% of subjects treated with placebo-PDT (2/42). Histological clearance of the main target lesion was seen in 76% of Ameluz PDT treated
patients versus 19% with Placebo-PDT, and
Dr. M. Shane Chapman, MBA, board certified dermatologist, Professor and Founding Chair, Department of Dermatology, Dartmouth Hitchcock Medical Center and the Dartmouth Geisel School of Medicine, and a key contributor to the Phase 3 study added “For many patients with superficial basal cell carcinoma — those with multiple lesions, lesions in cosmetically sensitive locations, or for whom surgery would not be preferred — treatment options have been limited. This FDA approval for Ameluz® and the RhodoLED gives us a rigorously studied, non-surgical option that we can deliver in our office. As someone who has worked with PDT for many years, I see this as a meaningful expansion in the use of this treatment.”
1 Ameluz Prescribing information (https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208081s040lbl.pdf)
2 Scrivener Y, Grosshans E, Cribier B. Variations of basal cell carcinomas according to gender, age, location and histopathological subtype. Br J Dermatol. 2002;147(1):41–47
About Biofrontera Inc.
Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with photodynamic therapy (PDT). The Company’s products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, and superficial basal cell carcinoma, and are in development for additional indications. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X.
Investor Contact
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com
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