Outlook Therapeutics Requests Type A Meeting with FDA
Outlook Therapeutics (Nasdaq: OTLK) has requested a Type A Meeting with the FDA following a Complete Response Letter (CRL) regarding their ONS-5010 biologics license application. The CRL, issued on August 27, 2025, acknowledged that the NORSE TWO pivotal trial met safety and efficacy endpoints but recommended additional confirmatory evidence for the wet AMD treatment.
ONS-5010 is an investigational ophthalmic formulation of bevacizumab designed to provide a regulated alternative to compounded bevacizumab, which has been used off-label as a first-line wet-AMD treatment. The Type A meeting aims to clarify the specific confirmatory evidence required by the FDA for approval.
Outlook Therapeutics (Nasdaq: OTLK) ha richiesto un incontro di Tipo A con la FDA dopo aver ricevuto una Complete Response Letter (CRL) relativa alla domanda di autorizzazione biologica per ONS-5010. La CRL, emessa il 27 agosto 2025, ha confermato che lo studio pivotale NORSE TWO ha raggiunto gli endpoint di sicurezza ed efficacia, ma ha raccomandato ulteriori evidenze confermative per il trattamento della degenerazione maculare umida (wet AMD).
ONS-5010 è una formulazione oftalmica sperimentale di bevacizumab sviluppata come alternativa regolamentata al bevacizumab preparato in compounding, usato off-label come trattamento di prima linea per la wet AMD. L'incontro di Tipo A servirà a chiarire quali prove confermative specifiche la FDA ritiene necessarie per concedere l'approvazione.
Outlook Therapeutics (Nasdaq: OTLK) ha solicitado una reunión Tipo A con la FDA tras recibir una Complete Response Letter (CRL) sobre su solicitud de licencia biológica para ONS-5010. La CRL, emitida el 27 de agosto de 2025, reconoció que el ensayo pivotal NORSE TWO cumplió los criterios de seguridad y eficacia, pero recomendó evidencia confirmatoria adicional para el tratamiento de la DMAH húmeda (wet AMD).
ONS-5010 es una formulación oftálmica en investigación de bevacizumab diseñada para ofrecer una alternativa regulada al bevacizumab preparado por compounding, que se ha usado off-label como tratamiento de primera línea para la wet AMD. La reunión Tipo A pretende clarificar qué evidencia confirmatoria concreta exige la FDA para la aprobación.
Outlook Therapeutics (Nasdaq: OTLK)는 ONS-5010 생물학적 제제 품목허가에 대한 Complete Response Letter(CRL) 발행 후 FDA에 Type A 미팅을 요청했습니다. 2025년 8월 27일 발행된 CRL은 NORSE TWO 중추 임상이 안전성과 유효성 평가를 충족했음을 인정하면서도, 습성 황반변성(wet AMD) 치료를 위해 추가적인 확증적 근거를 권고했습니다.
ONS-5010은 오프라벨로 1차 치료에 사용되어 온 조제형(bevacizumab compounding)과 달리 규제된 대안으로 개발 중인 베바시주맙의 안과용 시험 제형입니다. Type A 미팅은 FDA가 승인에 필요하다고 보는 구체적 확증 근거가 무엇인지 명확히 하기 위한 것입니다.
Outlook Therapeutics (Nasdaq: OTLK) a demandé une réunion de type A avec la FDA après réception d'une Complete Response Letter (CRL) concernant sa demande d'autorisation biologique pour ONS-5010. La CRL, datée du 27 août 2025, a reconnu que l'essai pivot NORSE TWO avait atteint les critères de sécurité et d'efficacité, mais a recommandé des preuves confirmatoires supplémentaires pour le traitement de la DMLA humide (wet AMD).
ONS-5010 est une formulation ophtalmique expérimentale de bevacizumab conçue pour offrir une alternative réglementée au bevacizumab préparé en compounding, utilisé hors AMM comme traitement de première intention de la wet AMD. La réunion de type A vise à préciser quelles preuves confirmatoires la FDA exige pour l'approbation.
Outlook Therapeutics (Nasdaq: OTLK) hat nach Erhalt eines Complete Response Letter (CRL) zur Biologika-Zulassungsanmeldung für ONS-5010 ein Type-A-Meeting mit der FDA beantragt. Das CRL, ausgestellt am 27. August 2025, stellte fest, dass die NORSE-TWO-Pivotalstudie die Sicherheits- und Wirksamkeitsendpunkte erreicht hat, empfahl jedoch zusätzliche bestätigende Nachweise für die Behandlung der neovaskulären Makuladegeneration (wet AMD).
ONS-5010 ist eine experimentelle ophthalmische Formulierung von Bevacizumab, die als regulierte Alternative zu kompoundiertem Bevacizumab entwickelt wird, das off-label als Erstlinienbehandlung bei wet AMD verwendet wurde. Das Type-A-Meeting soll klären, welche spezifischen bestätigenden Nachweise die FDA für eine Zulassung verlangt.
- NORSE TWO pivotal trial successfully met safety and efficacy endpoints
- Company taking proactive steps to address FDA requirements through Type A meeting
- Product addresses regulatory oversight concerns in current wet-AMD treatment market
- FDA requires additional confirmatory evidence for ONS-5010 approval
- BLA resubmission received Complete Response Letter, delaying potential approval
- Timeline for potential approval remains uncertain pending FDA meeting outcome
ISELIN, N.J., Sept. 02, 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 that a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.
In the FDA’s recently issued CRL, although the Agency acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, it recommended that confirmatory evidence of efficacy be submitted to support the application for ONS-5010. The requested Type A meeting seeks to clarify the details of the confirmatory evidence required by the FDA.
“We believe this Type A meeting will provide us with additional clarity on the FDA’s requirements to remedy the deficiency identified in the CRL,” commented Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “The Outlook Therapeutics team remains dedicated to our mission to provide patients in the U.S. with a safe and effective alternative to compounded bevacizumab, which has been used off-label as a first-line treatment for wet-AMD for years despite concerns around potency, sterility, consistency and regulatory oversight associated with the use of compounded products.”
About ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma)
ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab 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 meet with the FDA, seek additional clarity on the FDA’s requirements to and work 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 to mitigate certain risks associated with the current off-label use of repackaged bevacizumab, 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
FAQ
What was the FDA's response to Outlook Therapeutics' (OTLK) ONS-5010 BLA submission?
What is ONS-5010 being developed for by Outlook Therapeutics?
Why did Outlook Therapeutics request a Type A Meeting with the FDA?
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How does ONS-5010 differ from current wet-AMD treatments?
