Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010
Outlook Therapeutics (Nasdaq: OTLK) re-submitted its Biologics License Application (BLA) for ONS-5010 to the U.S. FDA on Nov 3, 2025 after receiving official minutes from an FDA Type A meeting held in September 2025. ONS-5010 is an investigational ophthalmic bevacizumab formulation proposed to be branded LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).
The company said the resubmission is intended to resolve the outstanding issue identified in a Complete Response Letter (CRL) dated August 2025 and that it is accelerating commercial efforts in Europe while positioning for a potential near-term U.S. approval.
Outlook Therapeutics (Nasdaq: OTLK) ha nuovamente presentato la sua Biologics License Application (BLA) per ONS-5010 alla FDA statunitense il 3 novembre 2025, dopo aver ricevuto i verbali ufficiali di una riunione di tipo A con la FDA tenutasi a settembre 2025. ONS-5010 è una formulazione oftalmica sperimentale di bevacizumab proposta per essere marchiata LYTENAVA™ (bevacizumab-vikg) per il trattamento della degenerazione maculare legata all'età in fase essudativa (wet AMD).
L'azienda ha dichiarato che la presentazione ripetuta è finalizzata a risolvere la questione in sospeso identificata in una Lettera di risposta completa (CRL) risalente ad agosto 2025 e che sta accelerando gli sforzi commerciali in Europa mentre si posiziona per un potenziale'approvazione statunitense a breve termine.
Outlook Therapeutics (Nasdaq: OTLK) presentó nuevamente su Solicitation de Licencia Biológica (BLA) para ONS-5010 ante la FDA de EE. UU. el 3 de noviembre de 2025, después de recibir las actas oficiales de una reunión de Tipo A de la FDA celebrada en septiembre de 2025. ONS-5010 es una formulación oftálmica experimental de bevacizumab propuesta para ser comercializada como LYTENAVA™ (bevacizumab-vikg) para el tratamiento de la degeneración macular relacionada con la edad en su forma húmeda (wet AMD).
La compañía dijo que la nueva presentación tiene como objetivo resolver el asunto pendiente identificado en una Carta de Respuesta Completa (CRL) fechada en agosto de 2025 y que está acelerando los esfuerzos comerciales en Europa mientras se posiciona para una posible aprobación en EE. UU. a corto plazo.
Outlook Therapeutics (Nasdaq: OTLK)가 2025년 11월 3일 FDA의 생물학적 제제 허가 신청(BLA)를 미국 FDA에 재제출했으며, 2025년 9월에 개최된 FDA Type A 회의의 공식 회의록을 받은 후에 이와 같은 조치를 취했습니다. ONS-5010은 LYTENAVA™ (bevacizumab-vikg)로 브랜드화될 예정인 망막질환 치료용 시험적 안과용 베바시주맙 제형입니다.
회사는 재제출이 2025년 8월에 작성된 완전 응답 서한(CRL)에서 지적된 문제를 해결하기 위한 것이며, 유럽에서의 상업적 노력을 가속화하고 미국 내 근시일 내 승인을 위한 위치를 마련하고 있다고 밝혔습니다.
Outlook Therapeutics (Nasdaq: OTLK) a de nouveau soumis sa Biologics License Application (BLA) pour ONS-5010 à la FDA américaine le 3 novembre 2025, après avoir reçu les procès-verbaux officiels d'une réunion de type A de la FDA tenue en septembre 2025. ONS-5010 est une formulation ophtalmique expérimentale de bevacizumab proposée pour être commercialisée sous le nom LYTENAVA™ (bevacizumab-vikg) pour le traitement de la dégénérescence maculaire liée à l'âge humide (wet AMD).
La société a déclaré que la réouverture vise à résoudre la question en suspens identifiée dans une Lettre de réponse complète (CRL) datée d'août 2025 et qu'elle accélère ses efforts commerciaux en Europe tout en se positionnant pour une éventuelle approbation aux États-Unis à court terme.
Outlook Therapeutics (Nasdaq: OTLK) hat am 3. November 2025 erneut seinen Biologics License Application (BLA) für ONS-5010 bei der US-amerikanischen FDA eingereicht, nachdem offizielle Protokolle eines FDA Type-A-Meetings im September 2025 vorlagen. ONS-5010 ist eine experimentelle ophthalmische Bevacizumab-Formulierung, die voraussichtlich unter dem Markennamen LYTENAVA™ (bevacizumab-vikg) zur Behandlung der feuchten Makuladegeneration (wet AMD) eingesetzt werden soll.
Das Unternehmen sagte, die erneute Einreichung ziele darauf ab, das in einem Complete Response Letter (CRL) vom August 2025 identifizierte ausstehende Problem zu lösen, und beschleunigt seine kommerziellen Bemühungen in Europa, während es sich auf eine potenzielle Zulassung in den USA in naher Zukunft vorbereitet.
Outlook Therapeutics (ناسداك: OTLK) قدمت مرة أخرى طلب الحصول على ترخيص بيولوجي (BLA) لـ ONS-5010 لدى إدارة الغذاء والدواء الأمريكية في 3 نوفمبر 2025، بعد استلامها محاضر رسمية من اجتماع من النوع A مع FDA عقد في سبتمبر 2025. ONS-5010 هو صيغة عينات عينات بفي assistance ophthalmic bevacizumab مقترح أن يتم تسويقه كـ LYTENAVA™ (bevacizumab-vikg) لعلاج التنكس البقعي المرتبط بالعمر الرطب (wet AMD).
وقالت الشركة إن إعادة التقديم تهدف إلى حل القضية العالقة المحددة في رسالة استجابة كاملة (CRL) المؤرخة أغسطس 2025 وتعمل على تسريع الجهود التجارية في أوروبا بينما تجهز لApproval أمريكي محتمل في المدى القريب.
- BLA re-submitted to FDA on Nov 3, 2025
- Company aims to resolve Aug 2025 CRL issue
- Accelerating commercial efforts in Europe
- Previously received a Complete Response Letter (CRL) in Aug 2025
- U.S. approval remains uncertain until FDA acts on the resubmission
ISELIN, N.J., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, after receiving the official minutes from the FDA Type A meeting conducted in September 2025. ONS-5010 is an investigational ophthalmic formulation of bevacizumab which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).
“The resubmission of our BLA for ONS-5010 marks an important step forward in our mission to deliver a safe and effective ophthalmic bevacizumab for the treatment of wet AMD in the United States. Based on our productive meeting with the FDA in September, we believe this resubmission will resolve the outstanding issue highlighted in the Complete Response Letter (CRL) we received in August 2025. Looking ahead, we are accelerating our commercial efforts in Europe and positioning the Company for a potential near-term U.S. approval,” commented Bob Jahr, Chief Executive Officer of Outlook Therapeutics.
About ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma)
ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.
In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. In certain European Union Member States ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold.
Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to optimize the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD.
In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “expect,” “intend,” “may,” “on track,” “plan,” “potential,” “seek,” “target,” “will,” or “would” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, plans to resubmit the BLA for ONS-5010 and the expected timing thereof, Outlook Therapeutics’ ability to provide the additional clarity required by the FDA’ and to address the deficiency identified in the CRL, the potential to obtain FDA approval for ONS-5010, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD, and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, including the risk that the Outlook Therapeutics is unable to address the issues identified in the CRL and ultimately obtain FDA approval, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, as supplemented by the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2025 and future reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, tariffs and trade tensions, fluctuations in interest rates and inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
OTLK@jtcir.com
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