Biofrontera Completes Treatment Phase In Phase 3 Trial Of Ameluz For Actinic Keratosis On Body; Supplemental New Drug Application Planned For Submission In Q2 2026

• All 172 patients have now entered the 12-month follow-up phase
• Trial involves larger surface areas, building on the approval in October 2024 for use of up to 3 tubes of Ameluz® per treatment
• Study results expected to form the basis of a supplemental New Drug Application (sNDA) planned for submission in Q2 2026

WOBURN, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced that the final patient completed the active treatment phase of its Phase 3 clinical trial evaluating Ameluz® (10% 5-aminolevulinic acid hydrochloride gel) PDT for mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk on September 3, 2025. All 172 enrolled patients have now entered the 12-month follow-up phase, expected to conclude in Q2 2026.

Actinic keratosis is a common precancerous skin condition found on sun-exposed areas of the body: 58 million US adults have at least one AK lesion1. If left untreated these may progress to cutaneous squamous cell carcinomas, with more than 70% originating from AK lesions2. Expanding treatment options for AKs beyond the face and scalp would therefore address a critical unmet need in dermatology.

This Phase 3 study is a multicenter, randomized, double-blind trial designed to evaluate the safety and efficacy of Ameluz® PDT versus vehicle gel in the treatment of actinic keratoses (AKs) on the extremities, neck and trunk. PDT was administered using a RhodoLED® or BF-RhodoLED® XL lamp following application of one to three tubes of either Ameluz® or vehicle to areas of approximately 80, 160 or 240 cm². Patients received a single PDT treatment, with a second one at 12 weeks if residual lesions remained. They are now being followed for 12 months to assess recurrence and new lesion development. In total, 172 subjects were enrolled in the study.