Outlook Therapeutics® Provides Update on Type A Meetings with FDA
02 November 2023 - 11:05PM
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 that it has completed the requested Type A Meetings
with the U.S. Food and Drug Administration (FDA) to discuss the
Complete Response Letter (CRL) dated August 29, 2023 regarding the
Biologics License Application (BLA) for ONS-5010, an
investigational ophthalmic formulation of bevacizumab under
development to treat wet AMD.
The FDA informed Outlook Therapeutics that an
additional adequate and well-controlled clinical trial would be
required for the approval of ONS-5010 for the treatment of wet AMD.
During the meetings, Outlook Therapeutics reached an agreement in
principle with the FDA on a clinical trial design that would most
likely allow for the resubmission of the ONS-5010 BLA as early as
the end of calendar year 2024, and subsequent approval around
mid-2025, pending final agreement on a clinical trial protocol with
the FDA and successful completion of the required additional
clinical trial. The FDA and Outlook Therapeutics also agreed on the
approaches needed to resolve the CMC comments in the CRL and
Outlook Therapeutics believes these efforts should be sufficient to
support approval.
“We are confident that we can meet the
additional requirements that the FDA is requiring for approval of
ONS-5010. The retina community of patients, physicians and payers
are all in need of an FDA-approved bevacizumab that meets
ophthalmic standards for the treatment of wet AMD, and we remain
focused on achieving this critical treatment option,” said Russell
Trenary, President and CEO of Outlook Therapeutics.
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. 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
Cencora, formerly AmerisourceBergen, entered into a strategic
commercialization agreement to expand the Company’s reach for
connecting to retina specialists and their patients. Cencora 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
the ability to remediate or otherwise resolve deficiencies
identified in the CRL, including with respect to the design and
completion of a subsequent clinical trial, anticipated timelines
for completion of another clinical trial and re-submission of a BLA
for ONS-5010, expectations concerning decisions of regulatory
bodies, including the FDA, and the timing 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,
receiving agreement from the FDA for any clinical trial protocols,
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 to be filed with the SEC, which
include the uncertainty of future impacts related to macroeconomic
factors, including as a result of the ongoing overseas conflict
between, 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
Outlook Therapeutics (NASDAQ:OTLKW)
Historical Stock Chart
From Aug 2024 to Sep 2024
Outlook Therapeutics (NASDAQ:OTLKW)
Historical Stock Chart
From Sep 2023 to Sep 2024