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Leverkusen, Germany (pta012/17.05.2023/09:20) - Biofrontera AG (FSE: B8F), an international biopharmaceutical company, announces the successful completion of the Phase I study evaluating the safety and tolerability of Ameluz®-PDT for the treatment of actinic keratosis (AK) with 3 tubes of Ameluz®. This trial was conducted to expand the approval of Ameluz® in the United States so that larger areas of AK-affected skin can be treated in one therapy session.
The study involved 100 patients with mild to severe actinic keratosis, each of them receiving the contents of 3 tubes of Ameluz® for a field-directed treatment of AK. Illumination was provided by Biofrontera's novel, larger RhodoLED® XL lamp. The first results of the study are expected in the fourth quarter of 2023.
"The study is part of the clinical development program Biofrontera Bioscience is conducting to expand the U.S. label of Ameluz®. This study paves the way for the use of up to three tubes of Ameluz® per treatment, although the use is currently limited to only one tube. This is to align the current reimbursement modalities with that of the competitor product, in order to be able to increase competitiveness in this very important market", explains Ms. de la Huerta, Chief Financial Officer of Biofrontera AG.
emitter: Biofrontera AG
address: Hemmelrather Weg 201, 51377 Leverkusen
contact person: Investor Relations
phone: +49 (0) 214 87 63 20
ISIN(s): DE0006046113 (share)
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