FDA approves Ameluz photodynamic therapy for superficial basal cell carcinoma
The FDA has expanded the approved use of Ameluz with red-light photodynamic therapy to include treatment of superficial basal cell carcinoma in adults.
The approval makes Ameluz with Biofrontera's RhodoLED system the first FDA-approved photodynamic therapy for a skin cancer and provides a non-surgical treatment option for eligible patients.
The expanded indication builds on Ameluz's established use in actinic keratosis and extends the company's photodynamic therapy platform into superficial basal cell carcinoma.
Field | Content |
Alert Type | Approval |
Drug Name | Aminolevulinic acid hydrochloride gel |
Brand Name | Ameluz |
Company | Biofrontera |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | Label expansion |
Indication | Treatment of superficial basal cell carcinoma in adults using Ameluz with red-light photodynamic therapy |
Therapy Area(s) | Dermatology; oncology; skin cancer |
Technology or Modality | Photodynamic therapy |
Device | RhodoLED red-light system |
Geography | United States |
What Happened | The FDA approved an expanded indication for Ameluz with red-light photodynamic therapy to treat superficial basal cell carcinoma in adults. |
Why It Matters | The approval establishes the first FDA-approved photodynamic therapy for a skin cancer and introduces a non-surgical option for eligible patients with superficial basal cell carcinoma. |
Supporting Context | Ameluz is already used with red-light photodynamic therapy for actinic keratosis and is activated by the RhodoLED treatment system. |
Key Takeaway | Ameluz with RhodoLED becomes the first FDA-approved photodynamic therapy for superficial basal cell carcinoma. |
What to Watch | Dermatology adoption, reimbursement and uptake relative to surgical and other non-surgical treatment options. |
Primary Source | Biofrontera |
Relevant Date | 14 September 2026 |
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