Biofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Photodynamic Therapy (PDT) for the Treatment of Actinic Keratoses (AK) on the Extremities, Neck and Trunk
Biofrontera (NASDAQ:BFRI) has announced the completion of the active treatment phase in its Phase 3 clinical trial for Ameluz® PDT, evaluating its effectiveness in treating actinic keratoses (AKs) on extremities, neck and trunk. The study, involving 172 patients, follows the October 2024 approval for using up to 3 tubes of Ameluz® per treatment.
The multicenter, randomized, double-blind trial tested Ameluz® PDT versus vehicle gel, with treatment areas ranging from 80 to 240 cm². Patients received one or two PDT treatments and have now entered a 12-month follow-up phase, expected to conclude in Q2 2026. Upon completion, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the FDA.
[ "Trial builds upon recent FDA approval for expanded Ameluz® usage (up to 3 tubes per treatment)", "Large market potential with 58 million US adults having at least one AK lesion", "Study addresses critical unmet need in dermatology for AK treatment beyond face and scalp", "Successful completion of active treatment phase with all 172 patients enrolled" ]Biofrontera (NASDAQ:BFRI) ha annunciato il completamento della fase di trattamento attivo nel suo trial di fase 3 per Ameluz® PDT, valutandone l'efficacia nel trattamento delle cheratosi attiniche (AK) su estremità, collo e tronco. Lo studio, che coinvolge 172 pazienti, segue l'approvazione di ottobre 2024 per l'uso fino a 3 tubi di Ameluz® per trattamento. Il trial multicentrico, randomizzato, in doppio cieco ha confrontato Ameluz® PDT con gel veicolo, con aree di trattamento che vanno da 80 a 240 cm². I pazienti hanno ricevuto una o due sedute di PDT e ora hanno avviato una fase di follow-up di 12 mesi, prevista per concludersi nel secondo trimestre del 2026. Al completamento Biofrontera intende presentare una domanda di nuovo farmaco supplementare (sNDA) alla FDA.
Biofrontera (NASDAQ:BFRI) ha anunciado la finalización de la fase de tratamiento activo en su ensayo de fase 3 para Ameluz® PDT, evaluando su efectividad en el tratamiento de las queratosis actínicas (AK) en extremidades, cuello y tronco. El estudio, que involucra 172 pacientes, sigue la aprobación de octubre de 2024 para usar hasta 3 tubos de Ameluz® por tratamiento. El ensayo multicéntrico, aleatorizado, doble ciego comparó Ameluz® PDT frente a gel vehículo, con áreas de tratamiento que oscilaban entre 80 y 240 cm². Los pacientes recibieron una o dos tratamientos de PDT y ahora han iniciado una fase de seguimiento de 12 meses, que se espera concluya en el segundo trimestre de 2026. Al finalizar, Biofrontera tiene previsto presentar una solicitud de nuevo fármaco suplementaria (sNDA) a la FDA.
Biofrontera (NASDAQ:BFRI)는 Ameluz® PDT의 3상 임상에서 활성 치료 단계를 완료했다고 발표했습니다. 이는 사지 및 몸통의 광독성 각화증(AK) 치료 효능을 평가하는 연구로, 172명 환자를 포함합니다. 2024년 10월의 Ameluz®를 치료당 최대 3봉지까지 사용할 수 있는 승인을 따른 것입니다. 다기관 무작위 이중맹검 연구에서 Ameluz® PDT와 차구젤(차단제) 간의 비교를 실시했고, 치료 면적은 80~240 cm² 범위였습니다. 환자들은 1회 또는 2회의 PDT 치료를 받았으며 이제 12개월 추적관찰기에 진입했고, 2026년 2분기에 완료될 예정입니다. 완료 시 Biofrontera는 FDA에 sNDA(추가 신약 신청)를 제출할 계획입니다.
Biofrontera (NASDAQ:BFRI) a annoncé l’achèvement de la phase de traitement actif dans son essai de phase 3 pour Ameluz® PDT, évaluant son efficacité dans le traitement des kératoses actiniques (AK) sur les extrémités, le cou et le tronc. L’étude, impliquant 172 patients, fait suite à l’approbation d’octobre 2024 permettant l’utilisation jusqu’à 3 tubes d’Ameluz® par traitement. L’essai multicentrique, randomisé et en double aveugle a comparé Ameluz® PDT au gel véhicule, avec des zones de traitement allant de 80 à 240 cm². Les patients ont reçu une ou deux séances de PDT et entament désormais une phase de suivi de 12 mois, qui devrait se terminer au deuxième trimestre 2026. À l’issue, Biofrontera prévoit de déposer une demande de nouveau médicament subsidiaire (sNDA) auprès de la FDA.
Biofrontera (NASDAQ:BFRI) hat den Abschluss der aktiven Behandlungsphase in seiner Phase-3-Studie zu Ameluz® PDT bekannt gegeben, zur Bewertung der Wirksamkeit bei der Behandlung von actinischen Keratosen (AK) an Extremitäten, Hals und Rumpf. Die Studie, an der 172 Patienten beteiligt waren, folgt der im Oktober 2024 erteilten Genehmigung zur Anwendung von bis zu 3 Tuben Ameluz® pro Behandlung. Die multizentrische, randomisierte, doppelblinde Studie testete Ameluz® PDT versus Vehikel-Gel, mit Behandlungsflächen von 80 bis 240 cm². Die Patienten erhielten eine oder zwei PDT-Behandlungen und treten nun in eine 12-monatige Nachbeobachtungsphase ein, die voraussichtlich im 2. Quartal 2026 abgeschlossen wird. Nach Abschluss plant Biofrontera die Einreichung eines ergänzenden New-Drug-Applications (sNDA) bei der FDA.
Biofrontera (NASDAQ:BFRI) أعلنت عن اكتمال مرحلة العلاج النشط في تجربتها السريرية من المرحلة 3 لـ Ameluz® PDT، لتقييم فاعليته في علاج التقرنات الشمية actinic keratoses (AK) في الأطراف والرقبة والجذع. درس شارك فيه 172 مريضاً، ويتبع موافقة أكتوبر 2024 لاستخدام حتى 3 أنابيب من Ameluz® لكل علاج. اختبرت الدراسة متعددة المراكز وعشوائية ومزدوجة العمى Ameluz® PDT مقابل جل ناقل، مع مساحات علاجية تتراوح من 80 إلى 240 سم². تلقى المرضى علاج PDT واحد أو اثنان والآن دخلوا في مرحلة المتابعة لمدة 12 شهراً، المتوقع أن تختتم في الربع الثاني من 2026. عند الانتهاء، تخطط Biofrontera لتقديم طلب دواء جديد مكمل (sNDA) إلى FDA.
Biofrontera (NASDAQ:BFRI) 宣布完成其第三阶段临床试验中 Ameluz® PDT 的 актив治疗阶段，评估其在手臂、颈部及躯干的日光性光化治疗性角化病（AK）的有效性。该研究涉及 172 例患者，并延续了2024年10月批准每次治疗最多使用 3 支 Ameluz® 的规定。该多中心、随机、双盲试验将 Ameluz® PDT 与载体凝胶进行比较，治疗面积范围为 80 至 240 cm²。患者接受了一次或两次 PDT 治疗，现进入 12 个月随访阶段，预计于 2026 年第 2 季完成。完成后，Biofrontera 计划向 FDA 递交补充新药申请（sNDA）。
- None.
- Long waiting period until Q2 2026 for study completion and potential sNDA submission
- Final efficacy results still pending and success not guaranteed
Insights
Biofrontera's Phase 3 trial completion for Ameluz® on extremities marks significant market expansion potential following 2024's 3-tube approval.
Biofrontera has reached a significant milestone in its clinical development program with the completion of the active treatment phase in its Phase 3 trial for Ameluz® PDT. This study specifically targets actinic keratoses (AKs) on the extremities, neck, and trunk - expanding beyond the currently approved face and scalp indications. All 172 patients have now entered the 12-month follow-up phase, with study completion anticipated by Q2 2026.
The trial design is particularly noteworthy as it builds upon the October 2024 FDA approval for using up to 3 tubes of Ameluz® per treatment, allowing for treatment of larger surface areas (up to 240 cm²). This represents a strategic advancement in the product's clinical utility, as it addresses the real-world need to treat multiple lesions across broader anatomical regions.
From a market perspective, this expansion is substantial considering the epidemiology: 58 million US adults have at least one AK lesion, with over 70% of cutaneous squamous cell carcinomas originating from these precancerous lesions. The potential label expansion would address a critical gap in dermatological care, as current treatment options for non-facial AKs are limited.
The double-blind, randomized design comparing Ameluz® to vehicle gel strengthens the validity of any positive outcomes. The study's inclusion of recurrence and new lesion development over a 12-month period will provide valuable efficacy data on the durability of treatment response - a key consideration for both clinicians and payers when evaluating therapeutic options for precancerous conditions.
Assuming positive results and subsequent FDA approval following the planned Q2 2026 sNDA submission, Biofrontera would be positioned to significantly expand the addressable market for Ameluz® PDT, potentially strengthening its competitive position in the photodynamic therapy space.
- 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® (
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
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.
“We are delighted to reach this stage in our clinical program,” said Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “Building on the recent FDA approval for the use of up to 3 tubes of Ameluz® per treatment, today’s milestone marks another step in broadening the label and market potential for this product. Together, these developments reflect Biofrontera’s strategic progress toward leadership in PDT.”
Dr. Nathalie Zeitouni, Mohs surgeon and clinical investigator at Medical Dermatology Specialists, Professor of Dermatology at the University of Arizona COM Phoenix and the coordinating investigator in the study, expressed enthusiasm about its’ potential impact. “We frequently see people with AKs on the trunk and extremities, and current treatment options are limited. Expanding the use of Ameluz® PDT to these areas would be a welcome advancement for dermatologists and our patients.”
The 12-month follow-up phase is expected to be completed by Q2 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) that same quarter.
About Actinic Keratosis
AK is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp, arms or the back of the hands. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed.1
About Biofrontera Inc.
Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of any extraordinary external events; any changes in the Company’s relationship with its licensors; the ability of the Company’s licensors to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company’s ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz ® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company’s expectations; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.
Contact:
Investor Relations
Ben Shamsian, Lytham Partners
+1-646-829-9701
ir@bfri.com
References
1. Skin Cancer Foundation Actinic Keratosis Overview. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/#:~:text=Actinic%20keratosis%20(AK)%20is%20the,to%20ultraviolet%20(UV)%20radiation
2. Thomson et al, Br J Derm, 189 (1): July 2023; e4–e5
FAQ
What is the status of Biofrontera's (BFRI) Phase 3 trial for Ameluz® PDT?
What is the purpose of BFRI's Phase 3 study for Ameluz®?
When will Biofrontera (BFRI) submit the sNDA for Ameluz® expanded use?
How many tubes of Ameluz® can be used per treatment following the October 2024 approval?
What is the market potential for Ameluz® in treating actinic keratoses?
