Biofrontera Submits Supplemental New Drug Application to FDA to Expand Ameluz® Red Light PDT to Actinic Keratoses on the Full Body
The Phase 3 trial reported complete lesion clearance in 45.6% of Ameluz patients versus 16.7% with vehicle treatment.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Biofrontera (NASDAQ: BFRI) submitted an FDA application to expand Ameluz red-light photodynamic therapy to actinic keratoses beyond the face and scalp. The requested label covers mild-to-moderate lesions on the extremities, neck and trunk in treatment fields up to approximately 240 cm².
A randomized, vehicle-controlled Phase 3 trial enrolled 172 patients. Complete clearance of all treated lesions 12 weeks after the last treatment occurred in 45.6% of Ameluz patients versus 16.7% with vehicle treatment (p<0.0003). A Phase 1 study measuring drug exposure also supports the application. Approval is sought for an adjusted illumination protocol across all RhodoLED lamps and indications. FDA filing review occurs within 60 days of receipt to assess completeness, not grant approval.
Revenue grew 12% for full-year 2025 and about 25% for first-half 2026; Biofrontera expects additional approvals to accelerate growth.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointComplete lesion clearance reached 45.6% versus 16.7% with vehicle, 12 weeks after final treatment (p<0.0003).
- Moderate pointLabel-expansion application submitted for mild-to-moderate actinic keratoses on the extremities, neck and trunk.
- Moderate pointRevenue growth was 12% for full-year 2025 and about 25% for first-half 2026.
- Moderate pointSuperficial basal cell carcinoma approval expanded Ameluz's approved uses in September 2026.
- Minor pointSkin appearance was rated good or very good by investigators for 75.2% of patients and by 70.9% of patients.
3 minor points
- Minor point86.3% of patients indicated they would choose photodynamic therapy again for future treatment.
- Minor pointIllumination pain was no higher than in a comparable Ameluz study with treatment fields four times smaller.
- Minor point. Forward-looking: it has not happened yet and may not happen.Additional FDA approvals are expected by Biofrontera to accelerate revenue growth.
Negative
- Moderate pointFDA approval remains pending for the expanded actinic keratosis indication and adjusted illumination protocol.
Key Figures
- Phase 3 participants
- 172 patients
- Trial supporting the sNDA
- Complete clearance
- 45.6% vs 16.7%
- Ameluz PDT vs vehicle PDT; all treated AK lesions at 12 weeks after the last PDT
- P-value
- p<0.0003
- Full Analysis Set complete-clearance comparison
- Treatment field sizes
- Approximately 80, 160 and 240 cm²
- Phase 3 trial
- Illumination protocol
- 37 J/cm² within 15 minutes
- Adjusted protocol included in the sNDA
- FDA filing review
- Within 60 days of receipt
- Standard procedure to determine whether an sNDA is complete for substantive review
Previous Clinical trial Reports
-
Phase 3 reported 45.6% vs 16.7% complete clearance, directly supporting the submitted indication.
-
Database lock reported for the maximal-use PK study supporting this body-area sNDA.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
supplemental new drug application regulatory
photodynamic therapy medical
actinic keratoses medical
pharmacokinetics medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Submission seeks to extend the Ameluz® label beyond the face and scalp to treatment fields of up to approximately 240 cm² on the rest of the body, with an adjusted illumination protocol
WOBURN, Mass., Oct. 08, 2026 (GLOBE NEWSWIRE) -- 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 it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication for Ameluz® (aminolevulinic acid hydrochloride) topical gel,
Ameluz® PDT is currently FDA approved for AKs on the face and scalp and, since September 2026, for superficial basal cell carcinoma (sBCC). If approved, the new indication would make Ameluz® with red light the only PDT approved in the U.S. for AKs on full body.
Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, said: “This submission is the next step in converting our clinical program into label expansions. Coming only weeks after FDA approval of Ameluz® in combination with RhodoLED® red light for superficial basal cell carcinoma, it reflects our strategy of broadening the clinical utility of our red-light PDT platform. Many patients present with AKs well beyond the face and scalp. If approved, this expansion would allow dermatologists to treat these patients with the same Ameluz® product and the BF-RhodoLED® lamps already installed in their practices.” He continued, “Our revenue growth of
Nathalie Zeitouni, Professor of Dermatology at the University of Arizona College of Medicine – Phoenix and adjunct Professor of Oncology at Roswell Park Comprehensive Cancer Center, and coordinating investigator of the study, commented: “In my practice I see many patients with AKs well beyond the face and scalp: on the arms, legs, neck, chest and back. Treatment options for these areas are limited, and that remains a real unmet need. If approved, extending Ameluz® PDT to the extremities, neck and trunk would give dermatologists a field-directed option for these patients, and I look forward to having it available.”
The submission is supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial in 172 patients with AKs on the extremities, neck and trunk, and by a Phase 1 maximal-use pharmacokinetics (PK) study. In the Phase 3 trial, which evaluated 4 to 15 AK lesions in treatment fields of approximately 80, 160 and 240 cm², using one to three tubes of Ameluz®,
In addition to efficacy, Ameluz® PDT demonstrated favorable cosmetic outcomes and high patient satisfaction. Investigators rated the aesthetic appearance of treated skin as “good” or “very good” in
The sNDA also includes an adjusted illumination protocol, for which approval is being sought for all RhodoLED® lamps and all indications, intended to improve patient tolerability of the illumination. The light is ramped up to full intensity, held for a few minutes, and then cycled on and off until the full light dose of 37 J/cm2 is delivered within 15 minutes in total. PDT-related pain is known to increase with treatment field size; in the new study, pain during illumination with this protocol was no higher than in a comparable Ameluz® PDT study in which treatment fields were four times smaller.
Under standard FDA procedures, the agency conducts a filing review within 60 days of receipt of an sNDA to determine whether the application is sufficiently complete to permit a substantive review. The Company will continue to provide an updates.
AK is the most common pre-cancerous skin lesion and is caused by chronic sun exposure; if left untreated, AKs may progress to squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face and bald scalp, but also on other sun-exposed areas of the body. In 2020, approximately 58 million people in the U.S. were affected by AK and 13 million AK treatments were performed.1
1 https://www.skincancer.org/skin-cancer-information/actinic-keratosis/
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 PDT. The Company's products are used for the treatment of AKs on the face and scalp, 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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