Outlook Therapeutics® Participates in Virtual Investor “What This Means” Segment
Outlook Therapeutics (OTLK) announced that Jedd Comiskey, Senior Vice President and Head of Europe, participated in a Virtual Investor segment discussing the recent NICE recommendation of LYTENAVA™ (bevacizumab gamma) for treating wet age-related macular degeneration (wet AMD).
LYTENAVA™ is significant as it represents the first and only authorized ophthalmic formulation of bevacizumab for wet AMD treatment in adults in both the EU and UK. The company has secured regulatory approvals in these regions earlier this year, with an initial 10-year market exclusivity period.
Outlook Therapeutics (OTLK) ha annunciato che Jedd Comiskey, Vicepresidente Senior e Responsabile per l'Europa, ha partecipato a un segmento virtuale per gli investitori, discutendo la recente raccomandazione NICE per LYTENAVA™ (bevacizumab gamma) nel trattamento della degenerazione maculare legata all'età umida (wet AMD).
LYTENAVA™ è significativo poiché rappresenta la prima e unica formulazione oftalmica autorizzata di bevacizumab per il trattamento della wet AMD negli adulti sia nell'UE che nel Regno Unito. L'azienda ha ottenuto approvazioni regolatorie in queste regioni all'inizio di quest'anno, con un periodo iniziale di esclusività di mercato di 10 anni.
Outlook Therapeutics (OTLK) anunció que Jedd Comiskey, Vicepresidente Senior y Jefe de Europa, participó en un segmento virtual para inversores discutiendo la reciente recomendación de NICE para LYTENAVA™ (bevacizumab gamma) en el tratamiento de la degeneración macular asociada a la edad húmeda (wet AMD).
LYTENAVA™ es significativo ya que representa la primera y única formulación oftálmica autorizada de bevacizumab para el tratamiento de wet AMD en adultos tanto en la UE como en el Reino Unido. La compañía ha asegurado aprobaciones regulatorias en estas regiones a principios de este año, con un período de exclusividad de mercado inicial de 10 años.
Outlook Therapeutics (OTLK)는 제드 코미스키(Jedd Comiskey) 유럽 담당 수석 부사장이 최근 NICE 권고안에 대해 논의하기 위해 온라인 투자자 세그먼트에 참여했다고 발표했습니다. 이 권고안은 LYTENAVA™ (bevacizumab gamma)의 습기 관련 노인 황반변성 (wet AMD) 치료에 대한 것입니다.
LYTENAVA™는 성인을 위한 습기 관련 노인 황반변성 치료에 있어 EU와 영국에서 승인된 최초이자 유일한 안과 제형으로 중요합니다. 회사는 올 초 이 지역에서 규제 승인을 확보했으며, 초기 10년의 시장 독점권 기간을 보장받았습니다.
Outlook Therapeutics (OTLK) a annoncé que Jedd Comiskey, Vice-Président Senior et Responsable de l'Europe, a participé à un segment virtuel pour les investisseurs, discutant de la récente recommandation de NICE concernant LYTENAVA™ (bevacizumab gamma) pour le traitement de la dégénérescence maculaire liée à l'âge humide (wet AMD).
LYTENAVA™ est significatif car il représente la première et unique formulation ophtalmique autorisée de bevacizumab pour le traitement de la wet AMD chez les adultes dans l'UE et au Royaume-Uni. L'entreprise a obtenu des approbations réglementaires dans ces régions au début de cette année, avec une période initiale d'exclusivité sur le marché de 10 ans.
Outlook Therapeutics (OTLK) hat bekannt gegeben, dass Jedd Comiskey, Senior Vice President und Leiter für Europa, an einem virtuellen Investoren-Segment teilgenommen hat, in dem die aktuelle NICE-Empfehlung für LYTENAVA™ (bevacizumab gamma) zur Behandlung der feuchten altersbedingten Makuladegeneration (feuchte AMD) diskutiert wurde.
LYTENAVA™ ist bedeutsam, da es die erste und einzige zugelassene ophthalmologische Formulierung von Bevacizumab zur Behandlung von feuchter AMD bei Erwachsenen sowohl in der EU als auch im Vereinigten Königreich darstellt. Das Unternehmen hat in diesen Regionen zu Beginn dieses Jahres Genehmigungen erhalten, mit einer initialen Marktexklusivität von 10 Jahren.
- Secured NICE recommendation for LYTENAVA™ in the UK market
- First and only authorized ophthalmic bevacizumab formulation for wet AMD in EU and UK
- 10-year market exclusivity period granted
- Obtained both EU and UK regulatory approvals
- None.
Insights
The NICE recommendation for LYTENAVA™ in the UK represents a substantial market opportunity for Outlook Therapeutics in the <money>$7.5 billion</money> European wet AMD market. With 10 years of market exclusivity and being the first authorized ophthalmic formulation of bevacizumab, OTLK has positioned itself strategically in a market traditionally dominated by more expensive alternatives like Lucentis and Eylea. The NICE endorsement typically leads to widespread NHS adoption, potentially capturing a significant portion of the UK's <money>$800 million</money> wet AMD market.
For a company with a market cap of just <money>$61.8 million</money>, this regulatory milestone could catalyze substantial revenue growth. The cost-effectiveness emphasis of NICE suggests LYTENAVA™ could be priced competitively while maintaining healthy margins. This creates a compelling value proposition for both healthcare systems and shareholders, particularly given the aging European population and increasing wet AMD prevalence.
NICE's recommendation is particularly noteworthy as it validates LYTENAVA™'s clinical profile and cost-effectiveness. This decision will likely influence other European healthcare systems' reimbursement policies, as NICE assessments are widely respected globally. The authorization of LYTENAVA™ as the first ophthalmic formulation of bevacizumab addresses a long-standing regulatory gap, where off-label bevacizumab use was common despite lacking formal approval for ocular use.
The 10-year market exclusivity period provides critical protection against potential competitors, allowing Outlook Therapeutics to establish strong market presence. This regulatory framework, combined with NICE's endorsement, creates a unique first-mover advantage in a market seeking cost-effective solutions for wet AMD treatment.
Jedd Comiskey, Senior Vice President, Head of Europe, highlights the recent NICE recommendation of LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD
ISELIN, N.J., Jan. 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) earlier this year 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 Jedd Comiskey, Senior Vice President, Head of Europe of Outlook Therapeutics, participated in a Virtual Investor “What This Means” segment.
As part of the segment, Mr. Comiskey discussed that the National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ (bevacizumab gamma), as an option for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and UK and has an initial 10 years of market exclusivity.
The Virtual Investor “What This Means” segment featuring Outlook Therapeutics is now available here.
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 European Union (EU) and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for the treatment of wet age-related macular degeneration (wet AMD).
In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational and is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD.
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 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,” “continue,” “expect,” “may,” “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’ plans for commercial launch of LYTENAVA™ in the UK and EU and timing thereof, expectations concerning Outlook Therapeutics’ ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, including plans to resubmit the BLA for ONS-5010, Outlook Therapeutics’ commercialization strategy, expectations concerning decisions of regulatory bodies and the timing thereof, 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, 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
What is the significance of NICE's recommendation for OTLK's LYTENAVA™?
How long is OTLK's market exclusivity period for LYTENAVA™ in the EU and UK?
What makes LYTENAVA™ unique in the wet AMD treatment market?
When did OTLK receive regulatory approval for LYTENAVA™ in the EU and UK?
