Biofrontera Inc., a biopharmaceutical company recognized for its development and commercialization of PDT, recently disclosed significant findings from its Phase 3 study involving the application of Ameluz® with the BF-RhodoLED® lamp for treating sBCC (study ALA-BCC-CT013).
The study, which constitutes the first Phase 3 PDT exploration in US patients with sBCC, encompassed 187 individuals with confirmed superficial BCCs. Each participant underwent one cycle of two PDT routines, separated by 1-2 weeks, with a potential repeat three months later if necessary.
Results demonstrated the efficacy of Ameluz®-PDT in achieving complete clinical and histological clearance of targeted BCC lesions, showcasing a success rate of 65.5% in the Ameluz® group compared to just 4.8% in the placebo group (p<0.0001). Noteworthy clearances were observed with 75.9% and 83.4% for histological and clinical targets, respectively, within the Ameluz® arm.
Moreover, secondary effectiveness parameters exhibited equally compelling outcomes, underscoring the treatment’s significance in achieving total sBCC lesion clearance. Patient satisfaction rates post-treatment were notably high, with the majority expressing very good or good views on overall treatment efficacy and esthetic results.
Dr. Hermann Luebbert, CEO and Chairman of Biofrontera, expressed satisfaction with the study’s alignment with European findings. He further mentioned the intent to submit required documentation to the FDA by late Q2 or early Q3 of 2025 after concluding the one-year follow-up phase in December.
Notable investigators involved in the study, such as Dr. David Pariser and Dr. Todd Schlesinger, highlighted the potential benefits of FDA approval for patients, emphasizing reduced burdens and improved cosmetic prospects.
Basal Cell Carcinoma (BCC) is recognized as the most common form of skin cancer in the US, with millions of new cases annually. BCCs stem from abnormal basal cell growth within the skin, necessitating effective treatment to prevent invasive outcomes.
Biofrontera’s focus on dermatological conditions through PDT treatment signifies its commitment to addressing skin health concerns. The company’s efforts with Ameluz® and RhodoLED® lamp series highlight its dedication to combating Actinic Keratosis and other related skin disorders.
While the FDA approval process progresses, Biofrontera remains dedicated to furthering research, innovation, and potential treatment alternatives for dermatological conditions.
For additional information regarding Biofrontera Inc. and its initiatives, please visit www.biofrontera-us.com and follow the company on social media platforms.
Endorsements: This news article does not endorse any company mentioned in the 8-K SEC filing but is a factual representation of the disclosed information.
This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Biofrontera’s 8K filing here.
About Biofrontera
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Biofrontera Inc, a biopharmaceutical company, engages in the commercialization of pharmaceutical products for the treatment of dermatological conditions in the United States. The company's products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection.
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