Biofrontera Inc. reports news on the commercialization and development of photodynamic therapy in dermatology. The company’s core product platform includes Ameluz, an aminolevulinic acid hydrochloride topical gel used with the RhodoLED red-light lamp series, with an established focus on actinic keratoses and clinical programs addressing additional dermatologic conditions.
Recurring updates include financial results, U.S. commercial performance, clinical data for Ameluz PDT, FDA-related label-expansion activity, patent proceedings, and business updates tied to the company’s U.S. product rights, regulatory approvals, intellectual property, and manufacturing rights.
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Biofrontera Inc. (NASDAQ:BFRI) announced the completion of the last patient visit in a Phase I study for Ameluz® - PDT aimed at treating mild to severe actinic keratosis (AK). The study, conducted by Biofrontera Bioscience GmbH, explored the safety and tolerability of using three tubes of BF-200 ALA 10% gel in expanded treatment fields. Top line results are anticipated in Q4 2023. CEO Erica Monaco emphasized this milestone as a significant advancement, potentially allowing broader treatment areas and fewer office visits for patients. Actinic keratosis is a common pre-cancerous condition affecting approximately 58 million U.S. residents, highlighting the importance of effective treatment options.