Outlook Therapeutics® Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD
Outlook Therapeutics (Nasdaq: OTLK) announced the FDA's acceptance of their resubmitted Biologics License Application (BLA) for ONS-5010, their ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD). The FDA designated it as a Class 2 review with a PDUFA goal date of August 27, 2025.
If approved, ONS-5010 will be marketed as LYTENAVA™ in the United States and is expected to receive 12 years of regulatory exclusivity. The resubmission includes efficacy and safety data from the NORSE EIGHT trial, along with additional chemistry, manufacturing, and controls information requested by the FDA.
The company has already secured regulatory approval for this treatment in the European Union and United Kingdom, marking it as the first authorized ophthalmic formulation of bevacizumab for wet AMD in these regions.
Outlook Therapeutics (Nasdaq: OTLK) ha annunciato l'accettazione da parte della FDA della loro domanda di licenza biologica (BLA) rinnovata per ONS-5010, la loro formulazione oftalmica di bevacizumab per il trattamento della degenerazione maculare senile umida (wet AMD). La FDA l'ha designata come revisione di Classe 2 con una data obiettivo PDUFA del 27 agosto 2025.
Se approvato, ONS-5010 sarà commercializzato come LYTENAVA™ negli Stati Uniti e si prevede che riceverà 12 anni di esclusività regolatoria. La rinnovazione include dati di efficacia e sicurezza dal trial NORSE EIGHT, insieme a ulteriori informazioni su chimica, produzione e controlli richieste dalla FDA.
L'azienda ha già ottenuto l'approvazione regolatoria per questo trattamento nell'Unione Europea e nel Regno Unito, segnando così la prima formulazione oftalmica di bevacizumab autorizzata per wet AMD in queste regioni.
Outlook Therapeutics (Nasdaq: OTLK) anunció la aceptación por parte de la FDA de su solicitud de licencia biológica (BLA) reenvuelta para ONS-5010, su formulación oftálmica de bevacizumab para el tratamiento de la degeneración macular relacionada con la edad húmeda (wet AMD). La FDA la designó como revisión de Clase 2 con una fecha objetivo PDUFA del 27 de agosto de 2025.
Si se aprueba, ONS-5010 se comercializará como LYTENAVA™ en los Estados Unidos y se espera que reciba 12 años de exclusividad regulatoria. La reenvuelta incluye datos de eficacia y seguridad del ensayo NORSE EIGHT, junto con información adicional sobre química, fabricación y controles solicitada por la FDA.
La empresa ya ha obtenido la aprobación regulatoria para este tratamiento en la Unión Europea y el Reino Unido, marcando la primera formulación oftálmica de bevacizumab autorizada para wet AMD en estas regiones.
Outlook Therapeutics (Nasdaq: OTLK)는 습성 노인성 황반변성(wet AMD) 치료를 위한 베바시주맙의 안과 제형인 ONS-5010에 대한 재제출된 생물학적 제품 허가 신청(BLA)이 FDA에 의해 수용되었다고 발표했습니다. FDA는 이를 클래스 2 검토로 지정하며 2025년 8월 27일의 PDUFA 목표 날짜를 설정했습니다.
승인될 경우 ONS-5010은 미국에서 LYTENAVA™로 판매될 예정이며, 12년의 규제 독점권을 받을 것으로 예상됩니다. 재제출에는 NORSE EIGHT 임상시험의 효능 및 안전성 데이터와 함께 FDA가 요청한 추가 화학, 제조 및 품질 관리 정보가 포함되어 있습니다.
이 회사는 이미 유럽연합 및 영국에서 이 치료법에 대한 규제 승인을 확보했으며, 이 지역에서 습성 AMD에 대한 첫 번째 승인된 안과 제형으로 자리 잡고 있습니다.
Outlook Therapeutics (Nasdaq: OTLK) a annoncé l'acceptation par la FDA de sa demande de licence biologique (BLA) révisée pour ONS-5010, sa formulation ophtalmique de bévacizumab pour le traitement de la dégénérescence maculaire liée à l'âge humide (wet AMD). La FDA l'a désignée comme une révision de Classe 2 avec une date objectif PDUFA du 27 août 2025.
Si approuvé, ONS-5010 sera commercialisé sous le nom de LYTENAVA™ aux États-Unis et devrait bénéficier de 12 ans d'exclusivité réglementaire. La révision comprend des données sur l'efficacité et la sécurité issues de l'essai NORSE EIGHT, ainsi que des informations supplémentaires sur la chimie, la fabrication et les contrôles demandées par la FDA.
L'entreprise a déjà obtenu l'approbation réglementaire pour ce traitement dans l'Union européenne et au Royaume-Uni, marquant ainsi la première formulation ophtalmique de bévacizumab autorisée pour wet AMD dans ces régions.
Outlook Therapeutics (Nasdaq: OTLK) gab die Annahme ihres erneut eingereichten Antrags auf eine Biologika-Lizenz (BLA) für ONS-5010 bekannt, ihre ophthalmologische Formulierung von Bevacizumab zur Behandlung der feuchten altersbedingten Makuladegeneration (wet AMD). Die FDA hat dies als Klasse-2-Überprüfung eingestuft, mit einem PDUFA-Zieldatum vom 27. August 2025.
Im Falle einer Genehmigung wird ONS-5010 in den Vereinigten Staaten als LYTENAVA™ vermarktet und es wird erwartet, dass es 12 Jahre regulatorische Exklusivität erhält. Die erneute Einreichung umfasst Wirksamkeits- und Sicherheitsdaten aus der NORSE EIGHT-Studie sowie zusätzliche Informationen zu Chemie, Herstellung und Kontrollen, die von der FDA angefordert wurden.
Das Unternehmen hat bereits die regulatorische Genehmigung für diese Behandlung in der Europäischen Union und im Vereinigten Königreich erhalten und damit die erste genehmigte ophthalmologische Formulierung von Bevacizumab für wet AMD in diesen Regionen etabliert.
- Already secured regulatory approval in EU and UK markets
- Potential 12-year regulatory exclusivity period in US if approved
- Would be the first FDA-approved ophthalmic bevacizumab for wet AMD
- FDA accepted BLA resubmission with 6-month review timeline
- Previous Complete Response Letter (CRL) from FDA required additional clinical trial
- Final approval still uncertain pending FDA review
- Commercialization delayed until at least late 2025
Insights
The FDA's acceptance of Outlook Therapeutics' BLA resubmission for ONS-5010 represents a critical regulatory milestone for this small-cap company. After addressing a previous Complete Response Letter through the NORSE EIGHT clinical trial, securing this Class 2 review with a August 27, 2025 PDUFA date creates a clear regulatory timeline.
What makes this particularly significant is that ONS-5010 aims to be the first FDA-approved ophthalmic formulation of bevacizumab for wet AMD. Currently, retina specialists commonly use off-label, compounded Avastin (bevacizumab) injections for wet AMD due to cost considerations, but these lack the standardization and regulatory oversight of an approved product.
The 12 years of regulatory exclusivity mentioned would provide substantial market protection if approved. Importantly, the product has already secured regulatory approval in the EU and UK, which may partially de-risk the US approval process.
This acceptance indicates the FDA believes the resubmission package addresses previous deficiencies, including both clinical (NORSE EIGHT data) and manufacturing (CMC) requirements. For a company with a
Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025
- Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025
ISELIN, N.J., April 08, 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 the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD. The FDA has determined that the BLA is a Class 2 review, which results in a six-month review period from the date of resubmission. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025. ONS-5010, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) in the United States for the treatment of wet AMD and is expected to receive 12 years of regulatory exclusivity.
“Our team has worked diligently to advance our development and regulatory strategies for ONS-5010 to get to this point and we are proud of the continued progress we have been able to achieve,” commented Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics. “This BLA acceptance and PDUFA date are significant milestones in our continued mission to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD. We are committed to bringing an ophthalmic bevacizumab to market in the United States and are continuing our activities for potential commercialization.”
The ONS-5010 BLA resubmission was based on the efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing and controls (CMC) information requested by the FDA. As previously announced, following Type A meetings with the FDA in Q4 CY2023 to address the ONS-5010 Complete Response Letter (CRL), the FDA informed Outlook Therapeutics that, in order to meet the FDA’s requirement for a second adequate and well-controlled clinical trial of ONS-5010, it could conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 12 week study of treatment naïve patients with a primary efficacy endpoint at 8 weeks (NORSE EIGHT). Outlook Therapeutics believes that the complete data set for NORSE EIGHT and the additional CMC information in the BLA resubmission, combined with the data from the other NORSE clinical trials, provides the required evidence to support approval of the ONS-5010 BLA in the United States.
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.
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), 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 second quarter of calendar 2025. In the United States, ONS-5010/LYTENAVA™ is investigational, and a BLA has been resubmitted to the FDA. 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 in the resubmitted BLA, expectations concerning decisions of regulatory bodies and the timing thereof, including the PDFUA review goal date, expectations concerning the therapeutic potential of LYTENAVA™ as a treatment of wet AMD, 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, Outlook Therapeutics’ plans for commercial launch of LYTENAVA™ in the UK and EU and timing thereof, Outlook Therapeutics’ commercialization strategy, 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 is the PDUFA date for Outlook Therapeutics' ONS-5010 (OTLK) wet AMD treatment?
What regulatory exclusivity period will OTLK's LYTENAVA receive if approved in the US?
Which clinical trial data supported OTLK's BLA resubmission for ONS-5010?
Where has Outlook Therapeutics' ONS-5010 already received regulatory approval?
