Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical
company working to achieve FDA approval for the first ophthalmic
formulation of bevacizumab for the treatment of retinal diseases,
today announced the U.S. Food and Drug Administration (FDA) has
issued a CRL to the Company’s BLA for ONS-5010, an investigational
ophthalmic formulation of bevacizumab under development to treat
wet AMD. While the FDA acknowledged the NORSE TWO pivotal trial met
its safety and efficacy endpoints, the Agency concluded it could
not approve the BLA during this review cycle due to several CMC
issues, open observations from pre-approval manufacturing
inspections, and a lack of substantial evidence.
“We continue to believe in the public health
need to provide the retina community with an FDA-approved
bevacizumab treatment option for wet AMD. We will request a formal
meeting as soon as possible with the FDA to further understand the
BLA deficiencies and how best to resolve them. Following this
meeting with the FDA, the Company will be able to discuss next
steps and the expected timing for resolution,” said Russell
Trenary, President and CEO of Outlook Therapeutics.
Julia A. Haller, MD, Ophthalmologist-in-Chief at
Wills Eye Hospital and an Outlook Therapeutics Board member,
commented, “The retina community needs an FDA-approved ophthalmic
bevacizumab to deliver an alternative targeted on-label treatment
for patients with wet AMD.”
Investor Conference Call and
Webcast
Outlook Therapeutics management will host a
corporate update conference call and webcast today, August 30, 2023
at 8:30 AM ET.
Interested participants and investors may access
the conference call by dialing (877) 407-8291 (domestic) or (201)
689-8345 (international). The live webcast will be accessible on
the Events page of the Investors section of the Outlook
Therapeutics website, outlooktherapeutics.com, and will be archived
there for 90 days.
About ONS-5010 / LYTENAVA™
(bevacizumab-vikg)
ONS-5010 is an investigational ophthalmic
formulation of bevacizumab under development as an intravitreal
injection for the treatment of wet AMD and other retinal diseases.
Because no FDA-approved ophthalmic formulations of bevacizumab are
available currently, 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 would provide an FDA-approved
option for physicians that currently have no choice but to
prescribe unapproved repackaged oncologic 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 biopharmaceutical
company working to achieve FDA approval for the launch of 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. The FDA accepted Outlook
Therapeutics’ BLA submission for ONS-5010 to treat wet AMD with an
initial PDUFA goal date of August 29, 2023; FDA did not approve the
BLA during this review cycle and the Company is working with the
FDA to address the issues that have been raised so that the BLA may
be re-submitted. The submission is supported by Outlook
Therapeutics’ wet AMD 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. As part of the Company’s multi-year commercial planning
process, Outlook Therapeutics and AmerisourceBergen entered into a
strategic commercialization agreement to expand the Company’s reach
for connecting to retina specialists and their patients.
AmerisourceBergen will provide third-party logistics (3PL) services
and distribution, as well as pharmacovigilance services and other
services in the United States. 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,” “believe,”
“continue,” “could,” “estimate,” “expect,” “may,” “might,”
“intend,” “potential,” “predict,” “should,” or “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, expectations concerning
our ability to remediate or otherwise resolve deficiencies
identified in the CRL, expectations concerning a formal meeting
with the FDA and the outcome thereof, our plans to discuss next
steps and timing for resolution of deficiencies identified in the
CRL, expectations concerning decisions of regulatory bodies,
including the FDA, and the timing thereof, expectations concerning
our relationship with AmerisourceBergen and the benefits and
potential expansion thereof 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 pharmaceutical product candidates,
risks of conducting clinical trials and risks in obtaining
necessary regulatory approvals, the content and timing of the
expected follow up meeting with the FDA, the content and timing of
decisions by the FDA, as well as those risks detailed in Outlook
Therapeutics’ filings with the Securities and Exchange Commission
(the “SEC”), including the Annual Report on Form 10-K for the
fiscal year ended September 30, 2022 as supplemented by the
Quarterly Report on Form 10-Q for the quarter ended June 30, 2023,
in each case as filed with the SEC and future quarterly reports we
file with the SEC, which include the uncertainty of future impacts
related to macroeconomic factors, including as a result of the
ongoing conflict between Russia and Ukraine, 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.
CONTACTS:
Media Inquiries:Harriet UllmanVice
PresidentLaVoieHealthScienceT:
617.429.5475hullman@lavoiehealthscience.com
Investor
Inquiries:
Jenene Thomas Chief Executive Officer JTC Team, LLC T: 833.475.8247
OTLK@jtcir.com
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