Frequently Asked Questions:
- What is Ameluz now approved to treat? Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, used with the BF-RhodoLED lamp series, is FDA approved for actinic keratosis and, as of this approval, superficial basal cell carcinoma (sBCC) in adults.
- How does Ameluz photodynamic therapy work? The topical gel is applied to the lesion and then activated with red light from the RhodoLED lamp, triggering a photodynamic reaction that selectively destroys the targeted lesion cells without surgery.
- What did the phase 3 sBCC trial show? Among 187 adults with histologically confirmed sBCC, 66% of patients treated with Ameluz PDT achieved the composite primary endpoint of clinical and histological complete response at 12 weeks, compared with 5% treated with placebo-PDT.
The US Food and Drug Administration (FDA) has approved Biofrontera's supplemental new drug application for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, used with the BF-RhodoLED lamp series, for the treatment of superficial basal cell carcinoma (sBCC) in adults.¹
The September 14 approval by the FDA makes Ameluz photodynamic therapy (PDT) the first and only PDT regimen cleared by the agency to treat a skin cancer. It is also now the only topical PDT in the United States indicated for both a precancerous lesion, actinic keratosis, and a skin malignancy.¹
“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,” Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, said in a statement.¹ “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.”
Basal cell carcinoma is the most common skin cancer diagnosed within the US, with an estimated 3.6 million cases annually, of which the superficial subtype accounts for roughly 15% - 20%, or 540,000 to 720,000 diagnoses each year.¹,² Such lesions can extend several centimeters in diameter, frequently arise on the trunk and extremities, and often present as multiple lesions, a pattern for which nonsurgical, tissue-sparing options have remained limited.¹
Which Data Supported the Ameluz Treatment’s sBCC Approval?
The approval resulted from a multicenter, randomized, double-blind, vehicle-controlled phase 3 analysis involving 187 adult patients showing histologically confirmed sBCC.¹ The trial’s primary endpoint, a composite of clinical and histological complete response of a main target lesion 12 weeks after the final PDT cycle, was met by 66% of those on Ameluz PDT (95 of 145) compared with 5% given placebo-PDT (2 of 42).¹
Both histological clearance and complete clinical clearance of all target lesions followed a similar pattern, reaching 76% and 83% with Ameluz PDT versus 19% and 21% with placebo, respectively.¹ The most frequently reported adverse events observed by the investigative team were application-site reactions consistent with Ameluz's known safety profile.¹
How Does This Approval Expand Ameluz's Use in Dermatology?
Ameluz was previously approved only for actinic keratosis, and the sBCC indication broadens its addressable population using the same topical gel and red-light lamp platform, without requiring a new device.¹ Company leadership described the expansion as a growth driver for existing customers and an incentive for new practices to adopt the RhodoLED platform, while a dermatologist involved in the phase 3 program called it a rigorously studied, in-office alternative for patients with multiple lesions or tumors in cosmetically sensitive areas.¹
Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.
References
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.
