FDA Approves Ameluz Red-Light Therapy for Superficial Basal Cell Carcinoma
The U.S. Food and Drug Administration has approved a new use for Ameluz, a topical aminolevulinic acid hydrochloride gel, in combination with the BF-RhodoLED red-light system for the treatment of superficial basal cell carcinoma (sBCC) in adults.
Biofrontera Inc., the company behind Ameluz, announced the approval on September 14, 2026. According to the company, the decision makes Ameluz the first and only photodynamic therapy drug approved by the FDA for the treatment of a skin cancer in the United States. The newly approved indication expands the use of a treatment that was already approved for actinic keratosis, a precancerous skin condition.
What Is Superficial Basal Cell Carcinoma?
Basal cell carcinoma is the most common form of skin cancer. It usually grows slowly and is rarely life-threatening when diagnosed and treated appropriately, but untreated lesions can continue to enlarge and damage surrounding tissue.
Superficial basal cell carcinoma is one of the recognized histologic forms of BCC. It is commonly found on areas such as the trunk and extremities. Research has also associated superficial BCC with particular patterns of distribution and patient characteristics.
Biofrontera cites estimates of approximately 3.6 million BCC diagnoses each year in the United States. The company estimates that about 15% to 20% of BCC cases are superficial, although estimates can vary between studies and populations.
For some people with superficial BCC, particularly those with multiple lesions, a nonsurgical approach may be considered. The appropriate treatment depends on factors such as the tumor's location, size, subtype, number of lesions, and the patient's individual circumstances.
How Does Ameluz Photodynamic Therapy Work?
Photodynamic therapy, commonly called PDT, combines a photosensitizing medicine with a specific wavelength of light.
Ameluz contains aminolevulinic acid hydrochloride. After the medication is applied to the treatment area, it participates in a biochemical process that leads to the formation of photoactive compounds within treated cells. Exposure to the appropriate red light then activates these compounds.
The FDA prescribing information describes Ameluz as being used with a narrow-spectrum red-light source. For the BF-RhodoLED system, the treatment involves red-light illumination following application of the topical gel.
This approach differs from treatments that physically remove a tumor through surgery or destroy tissue through other methods. However, PDT is still a medical treatment that requires appropriate patient selection, lesion assessment, and follow-up by qualified healthcare professionals.
Evidence Behind the FDA Approval
The new indication was supported by a randomized, double-blind, placebo-controlled Phase 3 clinical trial involving 187 adults with histologically confirmed superficial basal cell carcinoma.
The study evaluated Ameluz in combination with PDT using the BF-RhodoLED lamp. Participants had lesions in areas including the face, forehead, bald scalp, extremities, neck, and trunk.
The primary endpoint was deliberately stringent. It required both clinical and histological complete response of a main target lesion 12 weeks after the start of the final PDT cycle.
According to the FDA-approved prescribing information and Biofrontera's announcement, 66% of participants treated with Ameluz PDT achieved this combined endpoint, compared with 5% of participants who received placebo-PDT. Specifically, 95 of 145 patients in the Ameluz group met the endpoint, compared with 2 of 42 in the placebo group.
Other study measurements also showed differences between the treatment groups. Histological clearance of the main target lesion occurred in 76% of patients receiving Ameluz PDT compared with 19% receiving placebo-PDT. Complete clinical clearance of all target lesions was reported in 83% of Ameluz-treated participants compared with 21% in the placebo group.
These results formed an important part of the evidence supporting the FDA's decision.
What Are the Potential Side Effects?
Like other medical treatments, Ameluz PDT can cause adverse reactions.
The company reported that the most common adverse reactions observed in the superficial BCC study were application-site reactions, consistent with the known safety profile of Ameluz PDT.
Patients should review the complete FDA-approved prescribing information with their healthcare professional before treatment. The prescribing information contains important details concerning indications, treatment procedures, warnings, precautions, adverse reactions, and other safety information.
A treatment that works for one type of skin cancer or lesion is not automatically appropriate for every BCC. Diagnosis and treatment planning should be based on professional examination and, when appropriate, histological confirmation.
Why the Approval Matters
The FDA decision expands the role of photodynamic therapy in dermatology.
Before this approval, Ameluz was already used with red-light PDT for actinic keratoses. The new indication adds superficial basal cell carcinoma to its approved uses.
Biofrontera said the same topical product and BF-RhodoLED lamp platform can be used for the new indication. This could allow dermatology practices that already have the necessary equipment to incorporate the treatment into their existing PDT services, subject to the approved labeling and clinical judgment.
The company has said it expects to launch the superficial BCC indication from late in the fourth quarter of 2026 through the first quarter of 2027. That is a company projection rather than an FDA requirement or guarantee.
What Patients Should Know
The approval does not mean that Ameluz PDT will replace surgery or other established treatments for basal cell carcinoma.
Different BCCs can behave differently, and treatment decisions depend on the characteristics of each lesion. Factors such as tumor location, size, histological subtype, recurrence status, and patient preferences can influence the treatment discussion.
The new approval provides another FDA-authorized treatment option specifically for superficial BCC in adults. Patients diagnosed with this type of skin cancer should discuss all appropriate treatment choices with a dermatologist or other qualified healthcare professional.
It is also important to remember that successful treatment of one lesion does not eliminate the possibility of developing another skin cancer. Continued dermatologic surveillance and appropriate sun-protection measures remain important for people with a history of skin cancer.
The Bottom Line
The September 2026 FDA approval of Ameluz combined with BF-RhodoLED represents an expansion of photodynamic therapy into the treatment of superficial basal cell carcinoma.
The approval is supported by Phase 3 evidence showing higher rates of combined clinical and histological response with Ameluz PDT than with placebo-PDT. The treatment also gives eligible adults with superficial BCC an FDA-approved nonsurgical option that can be administered in a dermatology setting.
Further clinical experience will help establish how the treatment is incorporated into routine practice and how physicians select patients who may benefit from it.
For anyone diagnosed with superficial basal cell carcinoma, the most important step is to discuss the diagnosis and available treatment options with a qualified healthcare professional rather than relying on general information online.
Sources
- U.S. Food and Drug Administration. Ameluz Prescribing Information, revised 2026.
- Biofrontera Inc. Biofrontera Announces FDA Approval of Ameluz Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma, September 14, 2026.
- Scrivener Y, Grosshans E, Cribier B. Variations of basal cell carcinomas according to gender, age, location and histopathological subtype. British Journal of Dermatology. 2002;147(1):41-47.
Medical Disclaimer
This article is provided for general informational and educational purposes only. It is not medical advice, does not establish a doctor-patient relationship, and should not be used to diagnose, treat, or prevent any medical condition. FDA approvals, prescribing information, treatment recommendations, and clinical evidence can change. Patients should consult a qualified healthcare professional for advice about basal cell carcinoma, Ameluz PDT, or any other treatment. Do not start, stop, or change medical treatment based solely on this article.