Outlook Therapeutics® Participates in Virtual Investor “What This Means” Segment
Outlook Therapeutics (OTLK) announced that Dr. Jennifer Kissner, SVP Clinical Development, participated in a Virtual Investor segment to discuss the NORSE EIGHT clinical trial results. The segment focuses on the complete 12-week safety and efficacy data for ONS-5010, their ophthalmic bevacizumab formulation for wet AMD treatment.
The company, which has already secured regulatory approval in the European Union and United Kingdom for the first authorized ophthalmic bevacizumab formulation to treat wet age-related macular degeneration, plans to resubmit its Biologics License Application (BLA) in Q1 2025. NORSE EIGHT represents the second of two adequate and well-controlled clinical trials evaluating ONS-5010 in wet AMD patients.
Outlook Therapeutics (OTLK) ha annunciato che la Dr.ssa Jennifer Kissner, SVP Sviluppo Clinico, ha partecipato a un segmento virtuale per investitori per discutere i risultati del trial clinico NORSE EIGHT. Il segmento si concentra sui dati completi di sicurezza ed efficacia dopo 12 settimane per ONS-5010, la loro formulazione oftalmica di bevacizumab per il trattamento della degenerazione maculare legata all'età umida.
La società, che ha già ottenuto l'approvazione normativa nell'Unione Europea e nel Regno Unito per la prima formulazione oftalmica di bevacizumab autorizzata per trattare la degenerazione maculare legata all'età umida, prevede di ripresentare la sua Domanda di Licenza Biologica (BLA) nel primo trimestre del 2025. NORSE EIGHT rappresenta il secondo dei due trial clinici adeguati e ben controllati che valutano ONS-5010 nei pazienti con AMD umida.
Outlook Therapeutics (OTLK) anunció que la Dra. Jennifer Kissner, SVP de Desarrollo Clínico, participó en un segmento virtual para inversores para discutir los resultados del ensayo clínico NORSE EIGHT. El segmento se centra en los datos completos de seguridad y eficacia durante 12 semanas para ONS-5010, su formulación oftálmica de bevacizumab para el tratamiento de la degeneración macular asociada a la edad húmeda.
La empresa, que ya ha obtenido la aprobación regulatoria en la Unión Europea y el Reino Unido para la primera formulación oftálmica de bevacizumab autorizada para tratar la degeneración macular relacionada con la edad húmeda, planea volver a presentar su Solicitud de Licencia Biológica (BLA) en el primer trimestre de 2025. NORSE EIGHT representa el segundo de dos ensayos clínicos adecuados y bien controlados que evalúan ONS-5010 en pacientes con AMD húmeda.
Outlook Therapeutics (OTLK)는 Jennifer Kissner 박사가 임상 개발 수석 부사장으로서 가상 투자자 세션에 참여하여 NORSE EIGHT 임상 시험 결과에 대해 논의했다고 발표했습니다. 이 세션은 ONS-5010에 대한 12주간의 안전성 및 효능 데이터의 전체 내용을 다루고 있으며, 이는 습식 나이 관련 황반변성 치료를 위한 안과용 베바시주맙 제형입니다.
회사는 이미 습식 나이 관련 황반변성을 치료하기 위한 최초의 승인된 안과용 베바시주맙 제형에 대해 유럽 연합 및 영국에서 규제 승인을 확보한 상태이며, 2025년 1분기에 생물학적 라이선스 신청(BLA)을 재제출할 계획입니다. NORSE EIGHT는 습식 AMD 환자를 대상으로 ONS-5010을 평가하는 두 개의 적절하고 잘 통제된 임상 시험 중 두 번째입니다.
Outlook Therapeutics (OTLK) a annoncé que Dr. Jennifer Kissner, SVP du Développement Clinique, a participé à un segment virtuel pour les investisseurs afin de discuter des résultats de l'
L'entreprise, qui a déjà obtenu l'approbation réglementaire dans l'
Outlook Therapeutics (OTLK) gab bekannt, dass Dr. Jennifer Kissner, SVP für klinische Entwicklung, an einem virtuellen Investorensegment teilgenommen hat, um die Ergebnisse der NORSE EIGHT-Studie zu besprechen. Das Segment konzentriert sich auf die vollständigen 12-wöchigen Sicherheits- und Wirksamkeitsdaten für ONS-5010, ihre ophthalmologische Bevacizumab-Formulierung zur Behandlung von feuchter altersbedingter Makuladegeneration.
Das Unternehmen, das bereits die regulatorische Genehmigung in der Europäischen Union und im Vereinigten Königreich für die erste zugelassene ophthalmologische Bevacizumab-Formulierung zur Behandlung von feuchter altersbedingter Makuladegeneration erhalten hat, plant, im ersten Quartal 2025 seinen Biologics License Application (BLA) erneut einzureichen. NORSE EIGHT ist die zweite von zwei angemessenen und gut kontrollierten klinischen Studien, die ONS-5010 bei Patienten mit feuchter AMD bewertet.
- Secured regulatory approval in EU and UK for ophthalmic bevacizumab
- Completed NORSE EIGHT clinical trial with 12-week safety and efficacy data
- BLA resubmission planned for Q1 2025
- None.
Dr. Jennifer Kissner, SVP Clinical Development, discusses the 12-week safety and efficacy results for NORSE EIGHT clinical trial
Watch the “What This Means” segment here
ISELIN, N.J., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that Jennifer Kissner, Ph.D., SVP Clinical Development of Outlook Therapeutics participated in a Virtual Investor “What This Means” segment.
As part of the segment, Dr. Kissner discusses the complete 12-week safety and efficacy results for NORSE EIGHT, the second of two adequate and well controlled clinical trials evaluating ONS-5010 in wet AMD patients and the Company’s planned Biologics License Application (BLA) resubmission of ONS-5010 in the first quarter of calendar 2025.
The Virtual Investor “What This Means” segment featuring Outlook Therapeutics is now available here.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. 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 is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the first half of calendar 2025. In the United States, ONS-5010/LYTENAVA™ is investigational, is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD, and if successful, the data may be sufficient for Outlook to resubmit a BLA to the FDA in the United States. 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,” “may,” “plan,” “potential,” “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, Outlook Therapeutics’ ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, plans to resubmit the BLA for ONS-5010 and the timing thereof, Outlook Therapeutics’ plans for commercial launch of LYTENAVA™ in the UK and EU and timing thereof, expectations concerning the therapeutic potential of LYTENAVA™ as a treatment of wet AMD, Outlook Therapeutics’ commercialization strategy, expectations concerning decisions of regulatory bodies and the timing thereof, ONS-5010/LYTENAVA™’s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in the United States 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, 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 (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, and future quarterly 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, high interest rates, 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
When will Outlook Therapeutics (OTLK) resubmit its BLA for ONS-5010?
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What condition does Outlook Therapeutics' (OTLK) ONS-5010 treat?
