Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Biofrontera Pharma GmbH on +49 214 876 32 66 or Ameluz@biofrontera.com
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Ameluz® (78 mg/g 5-aminolaevulinic acid gel)
Progress in photodynamic therapy

Ameluz® (78 mg/g 5-aminolaevulinic acid gel, BF-200 ALA) is a topically applied prescription drug in gel form. It is used exclusively within photodynamic therapy (PDT).
Ameluz® is approved for:

  • the treatment of actinic keratosis (AK) of mild to moderate severity (grade 1 to 2 according to Olsen) and field cancerisation in adults1
  • the treatment of superficial and/or nodular basal cell carcinoma in adults not suitable for surgical treatment due to possible disease-related morbidity and/or poor cosmetic results1
Ameluz® Summary of Product Characteristics.

Ameluz® is a combination of the active substance 5-aminolaevulinic acid (5-ALA) with the nanoemulsion BF-200, which was specially developed for this product.2 The nanoemulsion helps to support some of the benefits of Ameluz®:

  • high 5-ALA stability in a gel formulation2
  • long shelf life after opening (12 weeks)1,2
  • helps transport ALA through the stratum corneum2
  • leading to high intraepidermal drug concentrations3

 

Ameluz® can be used for both conventional PDT and daylight PDT. PDT with Ameluz® enables effective treatment of photodamaged skin lesions with cosmetically beneficial results.1,2 This therapy offers:

  • simple treatment procedure
  • short treatment duration1
  • high efficacy in the treatment of AK and field cancerisation with conventional and daylight PDT1, 4
  • high efficacy in the treatment of superficial and nodular basal cell carcinoma with conventional PDT1,5
  • high patient satisfaction4,5

Aminolaevulinic acid

What is 5-aminolaevulinic acid?

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Nanoemulsion

 

The BF-200 nanoemulsion – it is all about the formulation

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Study data

 

Ameluz® (78 mg/g 5-aminolaevulinic acid gel) in clinical trials

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References

  1. Ameluz® Summary of Product Characteristics.
  2. Reinhold U. Future Oncol 2017;13:2413-2428.
  3. Maisch T et al. Exp Dermatol 2010;19: e302-305.
  4. Dirschka T et al. J Eur Acad Dermatol Venereol 2019;33:288-297.
  5. Morton C. et al. BJ Dermatol 2018;179(2):309-319

UKBF-2022-006e-V01, Date of Preparation: August 2022