Ameluz Approval History
- FDA approved: Yes (First approved May 10th, 2016)
- Brand name: Ameluz
- Generic name: aminolevulinic acid
- Dosage form: Gel
- Previous name: BF-200 ALA
- Company: Biofrontera AG
- Treatment for: Actinic Keratosis
Ameluz (aminolevulinic acid) is a porphyrin precursor used in combination with the BF-RhodoLED lamp for photodynamic therapy (PDT) treatment of actinic keratoses on the face and scalp.
FDA approval of Ameluz was based on safety and efficacy data from three pivotal multi-center clinical trials evaluating 779 patients with four to eight mild-to-moderate actinic keratosis (AK) lesions. Results demonstrated a complete patient response rate of 91% when paired with BF-RhodoLED PDT lamp.
Ameluz gel is applied to AK lesions by a healthcare professional, and then covered with a light blocking, occlusive dressing for three hours. After that time the gel is removed, and the area is illuminated with BF-RhodoLED red light. Ameluz increases photosensitivity, and patients should avoid exposure to sunlight, prolonged or intense light (such as tanning beds, sun lamps) for approximately 48 hours following treatment.
Common side effects include local skin reactions such as redness, pain/burning, itching and swelling.
Development History and FDA Approval Process for Ameluz
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.