Core Viewpoint - Biofrontera Inc. has completed the active treatment phase of its Phase 3 clinical trial for Ameluz PDT, targeting mild to moderate actinic keratoses, with all 172 patients now entering a 12-month follow-up phase expected to conclude in Q2 2026 [1][4]. Group 1: Clinical Trial Details - The Phase 3 study is a multicenter, randomized, double-blind trial assessing the safety and efficacy of Ameluz PDT compared to a vehicle gel for treating actinic keratoses on the extremities, neck, and trunk [3]. - Patients received one to three tubes of either Ameluz or vehicle gel applied to areas of approximately 80, 160, or 240 cm², with a single PDT treatment and a possible second treatment at 12 weeks if needed [3]. - The study enrolled a total of 172 subjects, who will be monitored for 12 months to evaluate recurrence and new lesion development [3][7]. Group 2: Market and Strategic Implications - The completion of this trial phase is seen as a significant milestone for Biofrontera, enhancing the market potential for Ameluz following recent FDA approval for using up to three tubes per treatment [4]. - The company plans to submit a supplemental New Drug Application (sNDA) to the FDA in Q2 2026, contingent on positive trial outcomes [4][7]. - Expanding treatment options for actinic keratoses beyond the face and scalp addresses a critical unmet need in dermatology, as 58 million US adults are affected by this condition [2][5]. Group 3: Company Overview - Biofrontera Inc. specializes in the treatment of dermatological conditions, focusing on photodynamic therapy (PDT) and commercializing the drug-device combination Ameluz with the RhodoLED lamp series [6]. - The company is actively conducting clinical trials to extend the use of its products for treating non-melanoma skin cancers and moderate to severe acne [6].