Outlook Therapeutics Provides Update on Type A Meeting with FDA
Outlook Therapeutics (NASDAQ: OTLK) has completed its Type A Meeting with the FDA regarding the Complete Response Letter (CRL) for ONS-5010, its investigational ophthalmic bevacizumab formulation for wet AMD treatment. The meeting focused on discussing the CRL received on August 27, 2025, concerning the company's biologics license application (BLA).
Following the FDA discussion, Outlook Therapeutics plans to resubmit its BLA before the end of 2025, after reviewing the agency's feedback and meeting minutes. CEO Bob Jahr described the FDA meeting as productive and reaffirmed the company's commitment to providing a safe and effective ophthalmic bevacizumab treatment option for wet AMD patients in the U.S.
Outlook Therapeutics (NASDAQ: OTLK) ha portato a termine l'incontro di Tipo A con la FDA riguardo alla Complete Response Letter (CRL) per ONS-5010, formulazione oftalmica sperimentale di bevacizumab per il trattamento della DMAE umida. L'incontro si è concentrato sulla CRL ricevuta il 27 agosto 2025 relativa alla domanda di licenza biologica (BLA) dell'azienda. Dopo la discussione con la FDA, Outlook Therapeutics prevede di ripresentare la BLA entro la fine del 2025, dopo aver esaminato i feedback dell'agenzia e il verbale dell'incontro. Il CEO Bob Jahr ha descritto l'incontro come produttivo e ha riaffermato l'impegno dell'azienda a fornire una trattamento sicuro ed efficace a base di bevacizumab oftalmico per i pazienti con DMAE umida negli Stati Uniti.
Outlook Therapeutics (NASDAQ: OTLK) ha completado su Reunión de Tipo A con la FDA respecto a la Complete Response Letter (CRL) para ONS-5010, su formulación oftalmológica en investigación de bevacizumab para el tratamiento de la DMAE húmeda. La reunión se centró en discutir la CRL recibida el 27 de agosto de 2025, relacionada con la solicitud de licencia de biologics (BLA) de la empresa. Tras la discusión con la FDA, Outlook Therapeutics planea volver a presentar su BLA antes de finales de 2025, tras revisar los comentarios de la agencia y las actas de la reunión. El CEO Bob Jahr describió la reunión como productiva y reafirmó el compromiso de la empresa de proporcionar una opción de tratamiento con bevacizumab oftalmológico segura y eficaz para pacientes con DMAE húmeda en EE. UU.
Outlook Therapeutics (NASDAQ: OTLK)은 rhes FDA와의 Type A 회의를 완료했으며, 습성 황반변성(AMD) 치료를 위한 연구 중인 눈용 베바시주맙 제형 ONS-5010에 대한 Complete Response Letter(CRL)에 관해 논의했습니다. 회의는 2025년 8월 27일에 접수된 CRL과 회사의 생물학적 제제 면허 신청(BLA)에 관한 논의에 중점을 두었습니다. FDA와의 논의 후 Outlook Therapeutics는 2025년 말까지 BLA를 재제출할 계획이며, 기관의 피드백과 회의록을 검토한 후에 그렇게 할 예정입니다. CEO Bob Jahr는 FDA 회의를 생산적이라고 평가했고 미국의 습성 AMD 환자들에게 안전하고 효과적인 눈용 베바시주맙 치료 옵션을 제공하겠다는 회사의 약속을 재확인했습니다.
Outlook Therapeutics (NASDAQ: OTLK) a terminé sa Réunion de Type A avec la FDA concernant la Complete Response Letter (CRL) pour ONS-5010, sa formulation ophtalmologique expérimentale de bevacizumab pour le traitement de la DMLA humide. La réunion s'est concentrée sur la CRL reçue le 27 août 2025 relative à la demande de licence biologics (BLA) de l'entreprise. Suite à la discussion avec la FDA, Outlook Therapeutics prévoit de resoumettre sa BLA d'ici la fin 2025, après examen des retours de l'agence et du compte rendu de la réunion. Le PDG Bob Jahr a décrit la réunion de manière productive et a réaffirmé l'engagement de l'entreprise à offrir une option de traitement ophtalmologique à base de bevacizumab sûre et efficace pour les patients atteints de DMLA humide aux États-Unis.
Outlook Therapeutics (NASDAQ: OTLK) hat sein Type-A-Meeting mit der FDA bezüglich des Complete Response Letter (CRL) für ONS-5010 abgeschlossen, einer experimentellen augenärztlichen Bevacizumab-Formulierung zur Behandlung der feuchten AMD. Das Meeting konzentrierte sich auf die CRL, die am 27. August 2025 im Zusammenhang mit dem Biologics License Application (BLA) des Unternehmens eingegangen ist. Nach der FDA-Diskussion plant Outlook Therapeutics, seine BLA vor Ende 2025 erneut einzureichen, nachdem das Feedback der Agentur und das Sitzungsprotokoll geprüft wurden. CEO Bob Jahr beschrieb das FDA-Meeting als produktiv und bestätigte erneut das Engagement des Unternehmens, eine sichere und wirksame augenärztliche Bevacizumab-Behandlung für Patienten mit feuchter AMD in den USA bereitzustellen.
Outlook Therapeutics (NASDAQ: OTLK) أكملت اجتماعا من النوع A مع إدارة الغذاء والدواء الأمريكية (FDA) بخصوص رسالة الاستجابة الكاملة (CRL) لـ ONS-5010، التركيبة العينية التجريبية من bevacizumab لعلاج AMD الرّطبة. يركّز الاجتماع على مناقشة CRL المستلمة في 27 أغسطس 2025 والمتعلقة بطلب ترخيص بيولوجي للشركة (BLA). عقب مناقشة FDA، تخطط Outlook Therapeutics لإعادة تقديم طلب BLA قبل نهاية 2025، بعد مراجعة تعليقات الوكالة ومحاضر الاجتماع. وصف الرئيس التنفيذي بوب يهر الاجتماع مع FDA بأنه مثمر وأعاد تأكيد التزام الشركة بتقديم خيار علاج bevacizumab عيني آمن وفعّال لمرضى AMD الرّطبة في الولايات المتحدة.
Outlook Therapeutics（纳斯达克股票代码：OTLK） 已完成与 FDA 的 Type A 会议，关于 ONS-5010 的 Complete Response Letter (CRL)，这是用于湿性 AMD 治疗的研究性眼用贝伐珠单抗制剂。会议重点讨论了于 2025 年 8 月 27 日收到的 CRL，涉及公司的生物制品许可申请（BLA）。在与 FDA 讨论后，Outlook Therapeutics 计划在 2025 年底前重新提交其 BLA，前提是审阅机构的反馈和会议纪要。CEO Bob Jahr 将此次 FDA 会议形容为富有成效，并重申公司致力于为美国湿性 AMD 患者提供安全有效的眼用贝伟珠单抗治疗选项的承诺。
- Company reports productive discussion with FDA regarding ONS-5010
- Clear timeline established for BLA resubmission by end of 2025
- Previous BLA submission received Complete Response Letter (CRL) indicating deficiencies
- Additional regulatory review and approval timeline extended due to resubmission requirement
ISELIN, N.J., Sept. 29, 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 it has completed the Type A Meeting with 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. Based on the discussion with the FDA, Outlook Therapeutics expects to resubmit its BLA before the end of calendar year 2025, after reviewing the agency’s feedback and meeting minutes.
“We had a productive discussion with the FDA. Based on our meeting, and pending receipt of the agency’s written minutes, we plan to resubmit the BLA later this year. We remain committed to providing patients, physicians and payors in the U.S. with a safe and effective ophthalmic bevacizumab for the treatment of wet AMD,” 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 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
FAQ
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