Ameluz Approval History
Reviewed on May 10, 2016 by J.Stewart BPharm.
- 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
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