Outlook Therapeutics to Participate in Retina World Congress 2022
May 10 2022 - 8:35AM
Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial
biopharmaceutical company working to develop and launch the first
FDA-approved ophthalmic formulation of bevacizumab for use in
retinal indications, today announced that Terry Dagnon, Chief
Operations Officer of Outlook Therapeutics, will be a panelist at
the Retina World Congress 2022 taking place May 12-15, 2022 in Fort
Lauderdale, Florida.
Details for the panel are as follows:
Session: Retina UnpluggedTitle:
Biosimilars (and other VEGFs)Panelist: Terry Dagnon,
Chief Operations Officer, Outlook TherapeuticsDate and
time: Thursday, May 12, 2022, 8:05 AM EDT
As part of the panel, Mr. Dagnon will discuss
Outlook Therapeutics’ ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an
investigational ophthalmic formulation of bevacizumab under
development to be administered as an intravitreal injection for the
treatment of wet AMD and other retinal diseases. In March 2022,
Outlook Therapeutics announced the submission to the U.S. Food and
Drug Administration (FDA) of its new Biologics License Application
(BLA) for ONS-5010 under the Public Health Service Act (PHSA)
351(a) regulatory pathway. If the BLA is approved, it is expected
to result in 12 years of marketing exclusivity for ONS-5010 as the
first and only ophthalmic formulation of bevacizumab approved by
the FDA to treat wet AMD.
“While off-label repackaged IV bevacizumab is
widely used for retina 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,” commented Terry Dagnon, Chief
Operations Officer 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. Over the course of its
development, there has been some misperception within the retina
community as to whether ONS-5010 is a biosimilar to Avastin®
(bevacizumab); however, with no 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 FDA
as a PHSA 351(a) new Biologics License Application (BLA).”
For more information about the 2022 Retina World
Congress, please visit the event website here.About
ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
ONS-5010 is an investigational ophthalmic
formulation of bevacizumab under development to be administered as
an intravitreal injection for the treatment of wet AMD and other
retinal diseases. Because no currently approved ophthalmic
formulations of bevacizumab are available, clinicians wishing to
treat retinal patients with bevacizumab have had to use unapproved
repackaged IV bevacizumab provided by compounding pharmacies,
products that have known risks of contamination and inconsistent
potency and availability. If approved, ONS-5010 can 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 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-vikg 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 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
retinal indications, 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 consists of three clinical
trials: NORSE ONE, NORSE TWO, and NORSE THREE. If ONS-5010
ophthalmic bevacizumab is approved, Outlook
Therapeutics expects to commercialize it as the first and only
FDA-approved ophthalmic formulation of bevacizumab for use in
treating retinal diseases in the United States, United
Kingdom, Europe, Japan and other markets. For more
information, please visit www.outlooktherapeutics.com.
Forward-Looking StatementsThis
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 “may,” “might,” “will,” “should,” “expect,” “plan,”
“anticipate,” “project,” “believe,” “estimate,” “predict,”
“potential,” “intend” or “continue,” the negative of terms like
these or other comparable terminology, and other words or terms of
similar meaning. These include, among others, statements about
ONS-5010’s potential 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 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 pharmaceutical product candidates,
risks of conducting clinical trials and risks in obtaining
necessary regulatory approvals, as well as those 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 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.
CONTACTS:Media
Inquiries:Harriet UllmanVice PresidentLaVoie Health
ScienceT: 617-669-3082hullman@lavoiehealthscience.com
Investor Inquiries:Jenene ThomasChief Executive
OfficerJTC Team, LLCT: 833.475.8247 OTLK@jtcir.com
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