ISELIN, N.J., May 10, 2022 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first ophthalmic formulation of bevacizumab approved by the FDA for use in retinal indications, today announced that Terry Dagnon, chief operating officer of Outlook Therapeutics, will be a panelist at the World Retina Congress 2022 May 12-15, 2022 in Fort Lauderdale, Florida.
The panel details are as follows:
Session: Unplugged Retina
Title: Biosimilars (and other VEGFs)
Panelist: Terry Dagnon, COO, Outlook Therapeutics
Date and time: Thursday, May 12, 2022, 8:05 a.m. EDT
As part of the panel, Mr. Dagnon will discuss ONS-5010/LYTENAVA™ (bevacizumab-vikg) from Outlook Therapeutics, an investigational ophthalmic formulation of bevacizumab in development that will be administered by intravitreal injection for the treatment of AMD. wet and other retinal diseases. In March 2022, Outlook Therapeutics announced the submission to the United States Food and Drug Administration (FDA) of its new Biologics License Application (BLA) for ONS-5010 under regulatory pathway 351(a) of the Public Health Service Act (PHSA). If the BLA is approved, it should translate to 12 years of market exclusivity for ONS-5010 as the first and only FDA-approved bevacizumab ophthalmic formulation to treat wet AMD.
“Although off-label repackaged IV bevacizumab is widely used for retinal diseases, it is not currently formulated or approved for ophthalmic use and these repackaged versions are widely known to be associated with public health concerns due to FDA compliance and safety issues,” Terry commented. Dagnon, COO of Outlook Therapeutics. “Our ophthalmic formulation, ONS-5010, is the first bevacizumab molecule specifically formulated and optimized to meet FDA standards for ophthalmic intravitreal injection. During its development, there has been some misperception within the retina community as to whether ONS-5010 is a biosimilar to Avastin® (bevacizumab); however, in the absence of FDA-approved ophthalmic indications for Avastin®, a biosimilar regulatory pathway is not legally possible. The ONS-5010 BLA was submitted on March 30, 2022 to the FDA as a new PHSA 351(a) Biologics License Application (BLA).
For more information on Retina World Congress 2022, please visit the event website here.
About ONS-5010/LYTENAVA™ (bevacizumab-vikg)
ONS-5010 is an investigational ophthalmic formulation of bevacizumab in development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulation of bevacizumab is available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab supplied by compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 may replace the need to use unapproved repackaged IV bevacizumab from compounding pharmacies for the treatment of wet AMD.
Bevacizumab-vikg 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 the biological activity of VEGF through steric blockade of VEGF binding to its Flt-1 (VEGFR-1) and KDR (VEGFR-2) receptors on the surface of endothelial cells. After intravitreal injection, the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage and the formation of new blood vessels in the retina.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a pre-commercial biopharmaceutical company working to develop and launch ONS-5010/LYTENAVA™ (bevacizumab-vikg), an investigational therapy, as the first FDA-approved ophthalmic formulation of bevacizumab for use in the indications retinal diseases, including wet AMD, DME and BRVO. Outlook Therapeutics has submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010 to treat wet AMD under the PHSA 351(a) regulatory pathway. The submission is supported by Outlook Therapeutics’ wet AMD registration clinical program, which includes three clinical trials: NORSE ONE, NORSE TWO and NORSE THREE. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics plans to commercialize it as the first and only ophthalmic formulation of bevacizumab approved by the FDA for use in the treatment of retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. For more information, please visit www.outlooktherapeutics.com.
This press release contains forward-looking statements. All statements other than statements of historical fact are “forward-looking statements,” including those relating to future events. In some instances, you can identify forward-looking statements by words such as “may”, “could”, “will”, “should”, “expect”, “plan”, “anticipate”, ” projects”, “believes”, “estimates”, “predicts”, “potential”, “intends” or “continues”, the negative of terms like these or other comparable terms, and other words or terms of similar meaning. These include, among other things, statements on the potential of ONS-5010 as the first FDA-approved ophthalmic formulation of bevacizumab-vikg, including expectations of market exclusivity, and plans for the commercialization of ONS-5010. Although Outlook Therapeutics believes it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations regarding future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations. and its business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include risks associated with the development of drug product candidates, risks associated with conducting clinical trials and risks associated with obtaining necessary regulatory approvals, as well as the risks detailed in Outlook Therapeutics filings. with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the fiscal year ended September 30, 2021 and subsequent quarterly reports on Form 10-Q, which include the uncertainty of future impacts related to the ongoing COVID-19 pandemic. These risks could cause actual results to differ materially from those expressed or implied by the forward-looking statements contained 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 undertakes no obligation to update, change or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. .
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