Outlook Therapeutics Confirms Status of Biologics License Application (BLA) Submission for ONS-5010
June 14 2022 - 8:05AM
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, is providing an update on its
Biologics License Application (BLA) submission for ONS-5010 /
LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related
macular degeneration (wet AMD).
As previously announced, Outlook Therapeutics
submitted its BLA for ONS-5010 to the FDA in March 2022 and
subsequently voluntarily withdrew its submission in May 2022 to
provide additional information requested by the FDA. Following
receipt of further correspondence from the FDA, Outlook
Therapeutics has confirmed the additional information necessary to
re-submit the BLA for ONS-5010.
C. Russell Trenary, President and Chief
Executive Officer of Outlook Therapeutics, commented, “The
additional correspondence from the FDA confirms our commitment to
our shareholders to re-submit a completed BLA to FDA by September
of this year. As stated previously, we believe the results from our
clinical trials demonstrated safety and efficacy and we are
on-track to re-submit this BLA and, if approved, to deliver the
first FDA-approved ophthalmic formulation of bevacizumab to the
retina community.”
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 must 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.
VEGF is a protein that promotes the growth of abnormal new blood
vessels and promotes leakage from these vessels, leading to retinal
edema and hemorrhage. With wet AMD, abnormally high levels of VEGF
are secreted in the eye and lead to loss of vision. Since the
advent of anti-VEGF therapy, it has become the standard-of-care
treatment option within the retina community globally.
About Outlook Therapeutics,
Inc.Outlook Therapeutics is a pre-commercial
biopharmaceutical company working to develop and launch ONS-5010/
LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic
formulation of bevacizumab for use in retinal indications,
including wet AMD, DME and BRVO. 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 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,” “estimate,” “expect,” “intend,” “may,”
“might,” “plan,” “potential,” “predict,” “project,” “should,”
“will,” 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, our
ability to provide adequate information to the FDA to support a
successful resubmission of the BLA, the timing of a resubmission of
the BLA and commercial launch 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:
833.475.8247OTLK@jtcir.com
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