{"id":798954,"date":"2025-01-08T10:35:24","date_gmt":"2025-01-08T15:35:24","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/outlook-therapeutics-participates-in-virtual-investor-what-this-means-segment\/"},"modified":"2025-01-08T10:35:24","modified_gmt":"2025-01-08T15:35:24","slug":"outlook-therapeutics-participates-in-virtual-investor-what-this-means-segment","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/outlook-therapeutics-participates-in-virtual-investor-what-this-means-segment\/","title":{"rendered":"Outlook Therapeutics\u00ae Participates in Virtual Investor \u201cWhat This Means\u201d Segment"},"content":{"rendered":"
\n

\n Jedd Comiskey, Senior Vice President, Head of Europe, highlights the recent NICE recommendation of LYTENAVA\u2122 (bevacizumab gamma) for the treatment of wet AMD<\/em>\n <\/p>\n

\n
\n Access the segment here<\/em>
\n <\/a>\n <\/p>\n

ISELIN, N.J., Jan. 08, 2025 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc.<\/a> (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 \u201cWhat This Means\u201d segment<\/a>.<\/p>\n

As part of the segment, Mr. Comiskey discussed that the National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA\u2122 (bevacizumab gamma), as an option for the treatment of wet AMD. LYTENAVA\u2122 (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.<\/p>\n

The Virtual Investor \u201cWhat This Means\u201d segment featuring Outlook Therapeutics is now available here<\/a>.<\/p>\n

\n About ONS-5010 \/ LYTENAVA\u2122 (bevacizumab-vikg, bevacizumab gamma)<\/strong>\n <\/p>\n

ONS-5010\/LYTENAVA\u2122 is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA\u2122 (bevacizumab gamma)<\/a> 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).<\/p>\n

In the United States, ONS-5010\/LYTENAVA\u2122 (bevacizumab-vikg) is investigational and is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD.<\/p>\n

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\u2019s 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.<\/p>\n

\n About Outlook Therapeutics, Inc.<\/strong>
\n \n <\/p>\n

Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010\/LYTENAVA\u2122 (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA\u2122 (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\u2122 (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\u2122 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\u2122, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.<\/p>\n

\n Forward-Looking Statements<\/strong>\n <\/p>\n

This press release contains forward-looking statements. All statements other than statements of historical facts are \u201cforward-looking statements,\u201d including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as \u201canticipate,\u201d \u201ccontinue,\u201d \u201cexpect,\u201d \u201cmay,\u201d \u201cpotential,\u201d \u201cwill,\u201d or \u201cwould\u201d the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, Outlook Therapeutics\u2019 plans for commercial launch of LYTENAVA\u2122 in the\u00a0UK\u00a0and EU and timing thereof, expectations concerning Outlook Therapeutics\u2019 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\u2019 commercialization strategy, expectations concerning decisions of regulatory bodies and the timing thereof, the therapeutic potential of LYTENAVA\u2122 as a treatment of wet AMD, ONS-5010\/LYTENAVA\u2122\u2019s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in\u00a0the United States, and other statements that are not historical fact. Although\u00a0Outlook Therapeutics\u00a0believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting\u00a0Outlook Therapeutics\u00a0and 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\u2019 resources, as well as those risks detailed in Outlook Therapeutics\u2019 filings with the\u00a0Securities and Exchange Commission\u00a0(SEC), including the Annual Report on Form 10-K for the fiscal year ended\u00a0September 30, 2024, filed with the\u00a0SEC\u00a0on\u00a0December 27, 2024, and future quarterly reports\u00a0Outlook Therapeutics\u00a0files with the\u00a0SEC, 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.\u00a0Outlook Therapeutics\u00a0does 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.<\/p>\n

\n Investor Inquiries:<\/strong>
\n
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
OTLK@jtcir.com<\/a><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Jedd Comiskey, Senior Vice President, Head of Europe, highlights the recent NICE recommendation of LYTENAVA\u2122 (bevacizumab gamma) for the treatment of wet AMD Access the segment here 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 \u201cWhat This Means\u201d segment. As part of the segment, Mr. Comiskey discussed that the National Institute for Health and Care … <\/p>\n

Continue reading “Outlook Therapeutics\u00ae Participates in Virtual Investor \u201cWhat This Means\u201d Segment”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-798954","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nOutlook Therapeutics\u00ae Participates in Virtual Investor \u201cWhat This Means\u201d Segment - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/outlook-therapeutics-participates-in-virtual-investor-what-this-means-segment\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Outlook Therapeutics\u00ae Participates in Virtual Investor \u201cWhat This Means\u201d Segment - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Jedd Comiskey, Senior Vice President, Head of Europe, highlights the recent NICE recommendation of LYTENAVA\u2122 (bevacizumab gamma) for the treatment of wet AMD Access the segment here 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 \u201cWhat This Means\u201d segment. 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