FDA Approves Ameluz Photodynamic Therapy as Nonsurgical Treatment for Superficial Basal Cell Carcinoma

Clinical Summary: 

• Design/Population: This randomized, double-blind, vehicle-controlled phase 3 trial evaluated aminolevulinic acid hydrochloride gel with red-light photodynamic therapy in adults with histologically confirmed superficial basal cell carcinoma.
• Key Outcomes: Ameluz photodynamic therapy produced substantially higher combined clinical and histologic complete response, histologic clearance, and complete clinical clearance of target lesions compared with placebo photodynamic therapy. The most common adverse reactions were application-site reactions.
• Clinical Relevance: This approval introduces the first FDA-approved photodynamic therapy for a skin cancer, providing a nonsurgical treatment option for adults with superficial basal cell carcinoma, including patients for whom tissue preservation or avoidance of surgery may be clinically important.

The US Food and Drug Administration (FDA) has approved aminolevulinic acid hydrochloride topical gel (Ameluz; Biofrontera) in combination with photodynamic therapy using the BF-RhodoLED lamp series for the treatment of adult patients with superficial basal cell carcinoma, making it the first FDA-approved photodynamic therapy for the treatment of a skin cancer.

The expanded indication provides a nonsurgical treatment option for superficial basal cell carcinoma using the same topical aminolevulinic acid hydrochloride gel and red-light photodynamic therapy platform already used for actinic keratosis. Superficial basal cell carcinoma lesions can occur on the trunk and extremities and may present as multiple lesions, creating a potential role for tissue-sparing approaches in appropriately selected patients.

FDA approval was supported by a multicenter, double-blind, vehicle-controlled phase 3 trial that enrolled 187 adults with histologically confirmed superficial basal cell carcinoma. Patients either received Ameluz photodynamic therapy or placebo photodynamic therapy. The primary end point was a composite of clinical and histologic complete response of the main target lesion at 12 weeks following initiation of the final photodynamic therapy cycle.

At analysis, the primary end point was achieved by 66% of patients receiving Ameluz photodynamic therapy compared with 5% receiving placebo photodynamic therapy. Histologic clearance of the main target lesion was observed in 76% and 19% of patients, respectively.

Complete clinical clearance of all target lesions was achieved by 83% of patients treated with Ameluz compared with 21% receiving placebo photodynamic therapy, further supporting the clinical activity of the treatment in superficial basal cell carcinoma.

The most common adverse reactions were application-site reactions, which were consistent with the established safety profile of Ameluz photodynamic therapy.

Ameluz was previously indicated for photodynamic treatment of actinic keratosis. The expanded indication makes the therapy the first FDA-approved photodynamic therapy for a skin cancer and provides dermatologists with an additional nonsurgical, tissue-sparing option for adults with superficial basal cell carcinoma. 

“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,” stated M. Shane Chapman, MD, MBA, Dartmouth Geisel School of Medicine. “This FDA approval for Ameluz and the RhodoLED gives us a rigorously studied, non-surgical option that we can deliver in our office.”

Source: 

Biofrontera. Biofrontera announces FDA approval of Ameluz® red light PDT for the treatment of superficial basal cell carcinoma. Accessed on: September 14, 2026. https://investors.biofrontera-us.com/full-news/