The FDA has approved Biofrontera's aminolevulinic acid hydrochloride 10% gel (Ameluz) in combination with the BF-RhodoLED lamp for treating adults with superficial basal cell carcinoma. This approval offers a non-surgical alternative for the 15% to 20% of the 3.5 million annual U.S. basal cell carcinoma cases that are superficial. In a phase III trial of 187 adults, the therapy achieved a 66% complete response rate compared to 5% for the control, though patients face risks of local pain, erythema, and eye injury.
FDA approval aminolevulinic acid
- ▪The FDA-approved photodynamic therapy requires aminolevulinic acid hydrochloride 10% gel to be applied by a healthcare provider and used in combination with Biofrontera's BF-RhodoLED lamp.
- ▪The combination of aminolevulinic acid hydrochloride 10% gel and the BF-RhodoLED lamp was previously approved by the FDA for treating actinic keratoses of the face and scalp in adults.
- ▪The FDA approved aminolevulinic acid hydrochloride 10% gel, marketed as Ameluz, in combination with photodynamic therapy for treating adults with superficial basal cell carcinoma on September 14, 2026.
Phase III trial results
- ▪In the phase III trial, 66% of patients receiving photodynamic therapy with aminolevulinic acid gel achieved a composite clinical and histological complete response compared to 5% receiving the vehicle.
- ▪The phase III trial showed histological clearance of 76% for the active photodynamic therapy group versus 19% for the vehicle group, and clinical clearance of 83% versus 21%.
- ▪A vehicle-controlled phase III trial of 187 adults with histologically confirmed superficial basal cell carcinoma supported the FDA approval of aminolevulinic acid hydrochloride 10% gel.
Superficial basal cell carcinoma
- ▪More than 3.5 million cases of basal cell carcinoma are diagnosed annually in the United States, with an estimated 15% to 20% of those classified as superficial basal cell carcinoma.
- ▪Superficial basal cell carcinoma often presents as multiple lesions on the trunk and extremities, making standard surgical approaches less than ideal for some patients.
Non-surgical treatment option
- ▪Photodynamic therapy using photosensitizers like 5-aminolevulinic acid or methyl aminolevulinate is recommended in clinical guidelines for low-risk skin cancers such as superficial basal cell carcinomas.
- ▪Investigator M. Shane Chapman, MD, MBA, stated that the FDA approval of Ameluz and the RhodoLED lamp provides a rigorously studied, non-surgical option deliverable in-office.
Photodynamic therapy adverse events
- ▪Common adverse events of photodynamic therapy with aminolevulinic acid include application site erythema, pain or burning, irritation, edema, pruritus, exfoliation, scabs, induration, vesicles, and paresthesia.
- ▪Warnings for photodynamic therapy with aminolevulinic acid include risks of hypersensitivity, transient amnestic episodes, eye injury from red-light therapy, increased photosensitivity, and mucous membrane irritation.
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