Biofrontera Inc. Announces New Patent Protection on Ameluz® until 2043 and the Completion of Patient Enrollment in Phase 2b Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Moderate to Severe Acne Vulgaris
Biofrontera Inc. (BFRI) has achieved two significant milestones: patent approval for Ameluz® extending protection until December 2043, and completion of patient enrollment in a Phase 2b study for acne treatment. The study evaluates Ameluz® photodynamic therapy (PDT) for moderate to severe acne vulgaris, enrolling 120 patients with treatments involving 1-hour and 3-hour incubation periods.
The U.S. acne treatment market, valued at $5.7 billion in 2024, is growing at a 5.3% CAGR. Over 55% of market spending goes to oral antibiotics and isotretinoin, which often have systemic side effects. With approximately 50 million Americans suffering from acne vulgaris, Ameluz® PDT could provide an alternative treatment option without the side effects associated with current systemic therapies.
The Phase 2b trial's last-patient-out is expected in Q3 2025, marking a crucial step in expanding Ameluz®'s indications beyond its current approval for mild to moderate actinic keratosis.Biofrontera Inc. (BFRI) ha raggiunto due importanti traguardi: l'approvazione del brevetto per Ameluz®, che estende la protezione fino a dicembre 2043, e il completamento del reclutamento dei pazienti in uno studio di Fase 2b per il trattamento dell'acne. Lo studio valuta la fototerapia dinamica con Ameluz® (PDT) per l'acne volgare da moderata a grave, arruolando 120 pazienti con trattamenti che prevedono periodi di incubazione di 1 e 3 ore.
Il mercato statunitense dei trattamenti per l'acne, valutato 5,7 miliardi di dollari nel 2024, cresce a un tasso annuo composto del 5,3%. Oltre il 55% della spesa di mercato è destinata ad antibiotici orali e isotretinoina, spesso associati a effetti collaterali sistemici. Con circa 50 milioni di americani affetti da acne volgare, la PDT con Ameluz® potrebbe rappresentare un'opzione terapeutica alternativa senza gli effetti collaterali delle terapie sistemiche attuali.
La conclusione dello studio di Fase 2b, con l'uscita dell'ultimo paziente, è prevista per il terzo trimestre del 2025, segnando un passo fondamentale per ampliare le indicazioni di Ameluz® oltre l'attuale approvazione per cheratosi attinica da lieve a moderata.
Biofrontera Inc. (BFRI) ha logrado dos hitos importantes: la aprobación de la patente para Ameluz®, que extiende la protección hasta diciembre de 2043, y la finalización del reclutamiento de pacientes en un estudio de Fase 2b para el tratamiento del acné. El estudio evalúa la terapia fotodinámica con Ameluz® (PDT) para el acné vulgar moderado a severo, inscribiendo a 120 pacientes con tratamientos que incluyen periodos de incubación de 1 y 3 horas.
El mercado estadounidense de tratamientos para el acné, valorado en 5,7 mil millones de dólares en 2024, crece a una tasa anual compuesta del 5,3%. Más del 55% del gasto del mercado se destina a antibióticos orales e isotretinoína, que a menudo presentan efectos secundarios sistémicos. Con aproximadamente 50 millones de estadounidenses afectados por acné vulgar, la PDT con Ameluz® podría ofrecer una opción de tratamiento alternativa sin los efectos secundarios asociados a las terapias sistémicas actuales.
Se espera que la salida del último paciente del ensayo de Fase 2b ocurra en el tercer trimestre de 2025, marcando un paso crucial para ampliar las indicaciones de Ameluz® más allá de su aprobación actual para la queratosis actínica leve a moderada.
Biofrontera Inc. (BFRI)는 두 가지 중요한 성과를 달성했습니다: Ameluz® 특허 승인으로 보호 기간이 2043년 12월까지 연장되었으며, 여드름 치료를 위한 2b상 임상시험 환자 등록이 완료되었습니다. 이 연구는 중등도에서 중증의 여드름을 대상으로 Ameluz® 광역학 치료(PDT)를 평가하며, 1시간 및 3시간의 배양 기간을 포함한 치료를 받는 120명의 환자를 등록했습니다.
미국 여드름 치료 시장은 2024년에 57억 달러 규모로, 연평균 성장률 5.3%를 기록하고 있습니다. 시장 지출의 55% 이상이 경구용 항생제와 이소트레티노인에 할당되며, 이들 약물은 종종 전신 부작용을 동반합니다. 약 5천만 명의 미국인이 여드름을 앓고 있는 가운데, Ameluz® PDT는 현재 전신 치료제와 관련된 부작용 없이 대체 치료 옵션을 제공할 수 있습니다.
2b상 임상시험의 마지막 환자 퇴원은 2025년 3분기로 예상되며, 이는 Ameluz®가 현재 승인된 경증에서 중등도의 광선각화증을 넘어 적응증을 확장하는 데 중요한 단계가 될 것입니다.
Biofrontera Inc. (BFRI) a atteint deux étapes importantes : l'approbation du brevet pour Ameluz®, prolongeant la protection jusqu'en décembre 2043, et la fin du recrutement des patients dans une étude de phase 2b pour le traitement de l'acné. L'étude évalue la thérapie photodynamique (PDT) avec Ameluz® pour l'acné vulgaire modérée à sévère, incluant 120 patients traités avec des périodes d'incubation de 1 heure et 3 heures.
Le marché américain du traitement de l'acné, estimé à 5,7 milliards de dollars en 2024, croît à un taux annuel composé de 5,3 %. Plus de 55 % des dépenses du marché sont consacrées aux antibiotiques oraux et à l'isotrétinoïne, qui présentent souvent des effets secondaires systémiques. Avec environ 50 millions d'Américains souffrant d'acné vulgaire, la PDT avec Ameluz® pourrait offrir une option de traitement alternative sans les effets secondaires associés aux thérapies systémiques actuelles.
La sortie du dernier patient de l'essai de phase 2b est prévue pour le troisième trimestre 2025, marquant une étape cruciale pour étendre les indications d'Ameluz® au-delà de son approbation actuelle pour la kératose actinique légère à modérée.
Biofrontera Inc. (BFRI) hat zwei bedeutende Meilensteine erreicht: die Patentgenehmigung für Ameluz®, die den Schutz bis Dezember 2043 verlängert, und den Abschluss der Patienteneinschreibung in einer Phase-2b-Studie zur Aknebehandlung. Die Studie bewertet die photodynamische Therapie (PDT) mit Ameluz® bei mittelschwerer bis schwerer Akne vulgaris und schließt 120 Patienten ein, die Behandlungen mit 1- und 3-stündigen Inkubationszeiten erhalten.
Der US-amerikanische Aknebehandlungsmarkt wird im Jahr 2024 auf 5,7 Milliarden US-Dollar geschätzt und wächst mit einer CAGR von 5,3 %. Über 55 % der Marktausgaben entfallen auf orale Antibiotika und Isotretinoin, die häufig systemische Nebenwirkungen verursachen. Da etwa 50 Millionen Amerikaner an Akne vulgaris leiden, könnte Ameluz® PDT eine alternative Behandlungsoption ohne die Nebenwirkungen der derzeitigen systemischen Therapien bieten.
Der Abschluss der Phase-2b-Studie mit dem letzten Patientenaustritt wird für das dritte Quartal 2025 erwartet und markiert einen wichtigen Schritt zur Erweiterung der Indikationen von Ameluz® über die derzeitige Zulassung für leichte bis mittelschwere aktinische Keratose hinaus.
- Patent protection for Ameluz® extended until December 2043, providing long-term protection against generic competition
- Successful completion of patient enrollment (120 patients) in Phase 2b trial for acne treatment
- Large market opportunity with U.S. acne treatment market valued at $5.7 billion and growing at 5.3% CAGR
- Potential expansion into new indication (acne) beyond current approval for actinic keratosis
- Phase 2b results not yet available - success not guaranteed
- Final trial results won't be available until after Q3 2025
Insights
Biofrontera secures critical patent protection until 2043 and advances acne clinical trials, strengthening market position and growth prospects.
This announcement contains two significant developments that substantially strengthen Biofrontera's commercial outlook. The patent approval for Ameluz's reformulation (without propylene glycol) extends protection until December 2043, effectively granting the company nearly two decades of market exclusivity. This patent shield represents extraordinary protection against generic competition in an industry where patent cliffs frequently devastate revenue streams.
Simultaneously, Biofrontera has completed enrollment of 120 patients in its Phase 2b trial evaluating Ameluz for moderate to severe acne vulgaris. The trial design, testing both 1-hour and 3-hour incubation periods, appears methodologically sound with appropriate blinding, randomization, and follow-up protocols. With the final patient expected to complete the study in Q3 2025, topline results should emerge by late 2025.
The company's strategic targeting of the acne market (valued at $5.7 billion with 5.3% CAGR) demonstrates excellent commercial foresight. Current standard treatments for moderate-to-severe acne—oral antibiotics and isotretinoin—comprise 55% of market spending but carry significant systemic side effects. Ameluz's photodynamic therapy (PDT) approach could potentially offer comparable efficacy without these complications, positioning it as a differentiated alternative in this substantial market.
The convergence of extended patent protection and expansion into the lucrative acne indication significantly enhances Biofrontera's long-term value proposition. If the Phase 2b results prove positive, the company would likely advance to Phase 3 trials, potentially achieving FDA approval for acne by approximately 2027-2028, with nearly 15 years of remaining patent exclusivity thereafter.
- Biofrontera has received patent approval for the revised formulation of Ameluz®, which extends patent protection through to December 2043
- Ameluz PDT offers the potential for effective treatment of moderate to severe acne without the side effects associated with some systemic therapies4
- Approximately 50 million people in the US are suffering from acne vulgaris, including both adolescents and adults1,2
- The US acne treatment market was valued at
$5.7 billion in 2024 and is growing annually5
WOBURN, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), received confirmation that the updated formulation of the Ameluz® nanoemulsion gel without propylene glycol received patent approval through to December 2043. The formulation was earlier accepted for use in Ameluz® by the US Food and Drug Administration (FDA) and is in use since 2024. In addition to this long-lasting protection of Ameluz® against generic competition, Biofrontera today announced the successful enrollment of the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris.
The multicenter, randomized, double-blind study is designed to assess the safety and efficacy of PDT with the BF-RhodoLED® lamp and Ameluz® or vehicle gel after two different incubation periods —1 hour and 3 hours. One tube of Ameluz® or vehicle gel is applied to the entire face, followed by illumination for 10 minutes after the specified incubation period has taken place.
Patients received up to three PDT sessions spaced one month apart and will receive follow-up consultations for two months following their final treatment. A total of 120 patients has been enrolled. The Company anticipates last-patient-out in Q3 2025, marking a key milestone in the clinical development of Ameluz® for a potential new dermatological indication.
Dr. Mitchel P. Goldman, MD, FAAD, the coordinating investigator of the study and Medical Director of Cosmetic Laser Dermatology and Platinum Dermatology Partners, expressed enthusiasm about its potential impact. “We see many patients who suffer from inflammatory acne. The possibility of expanding the indication for Ameluz® PDT to treat this disorder would be welcomed by physicians and our patients. I look forward to seeing the final results of the study.”
The U.S. acne treatment market was valued at approximately
“We are thrilled to reach this pivotal stage in our clinical program,” said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “The successful enrollment of our last patient in this important Phase 2b study brings us closer to offering an effective treatment option for patients with moderate to severe acne. It marks a significant step in expanding the indications for Ameluz® PDT over and above the currently approved treatment of mild to moderate actinic keratosis on the face and scalp. Together with our patent protection now lasting to December 2043, extensions of the Ameluz approved indications position our company for future growth.”
About Acne vulgaris
Acne vulgaris is the most common skin condition in the United States, affecting an estimated 50 million people annually1. While often associated with adolescence, studies have shown that acne affects approximately
According to U.S. clinical guidelines, treatment options for moderate to severe inflammatory acne include topical therapies, oral antibiotics, and isotretinoin which may have serious side effects4. As a result, there is a growing need for effective alternatives.
References:
- American Academy of Dermatology Association. Acne: Overview. https://www.aad.org/public/diseases/acne ↩
- Collier CN et al. “The prevalence of acne in adults 20 years and older.” J Am Acad Dermatol. 2008;58(1):56–59. ↩
- Tan JK, Bhate K. “A global perspective on the epidemiology of acne.” Br J Dermatol. 2015;172 Suppl 1:3–12. ↩
- Zaenglein AL et al. “Guidelines of care for the management of acne vulgaris.” J Am Acad Dermatol. 2016;74(5):945–973.e33. ↩
- Fortune Business Insights. Acne Treatment Market Size, Share & Trends Report, 2024–2032. https://www.fortunebusinessinsights.com/acne-treatment-market-102596 ↩
- IQVIA Institute Report, U.S. Dermatology Market Analysis, 2023. (Note: Replace with actual IQVIA data if available or request specific spending data from your market access team.)
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 Twitter.
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 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; 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; 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
Andrew Barwicki
1-516-662-9461
ir@bfri.com
FAQ
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