Outlook Therapeutics® Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010
27 November 2023 - 2:05PM
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 the receipt of the official minutes from the Type A
meeting with the U.S. Food and Drug Administration (FDA) held in
October 2023 regarding the Complete Response Letter (CRL) dated
August 29, 2023 for the Biologics License Application (BLA) for
ONS-5010, an investigational ophthalmic formulation of bevacizumab
under development to treat wet AMD.
As previously reported, the FDA requires an
additional adequate and well-controlled study to support the
ONS-5010 BLA. The FDA has informed Outlook Therapeutics that it can
conduct a non-inferiority study evaluating ONS-5010 versus
ranibizumab in a 3-month study of treatment naïve patients with a
primary endpoint at 2 months. As recommended by the FDA at the Type
A meeting, Outlook Therapeutics has been working with the Division
of Ophthalmology to design an appropriate study to satisfy the
FDA’s requirements. The FDA and Outlook Therapeutics have also
identified the approaches needed to resolve the CMC comments in the
CRL.
“We are encouraged by the productive discussions
we have had with the FDA regarding next steps for our ONS-5010
approval pathway. We continue to believe in the potential of
ONS-5010 to address the need here in the United States, as well as
globally, for an approved ophthalmic bevacizumab that meets FDA
standards for the treatment of wet AMD,” commented Russell Trenary,
President and CEO of Outlook Therapeutics.
Based on the October Type A meeting and ongoing
informal discussions with the FDA, Outlook Therapeutics has
submitted a protocol for review at an upcoming Type A meeting with
the FDA in December 2023. Upon confirmation of the protocol details
with the FDA, Outlook Therapeutics intends to submit a Special
Protocol Assessment (SPA) to memorialize the agreement with the FDA
on the trial design and confirm that, if successful, this
additional study, in combination with the successful completion of
the ongoing work related to the CMC requests in the CRL, would
support approval of a resubmitted ONS-5010 BLA. Outlook
Therapeutics continues to believe that the proposed clinical trial
design as included in the Type A meeting request would allow for
completion of the study in 2024 and resubmission of the ONS-5010
BLA by the end of calendar year 2024.
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; the 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,” “will,” or “would” 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 issued by the FDA,
including with respect to an additional clinical trial and CMS
issues, the timing for completion of an additional clinical trial
and resubmission of the BLA for ONS-5010, expectations concerning
decisions of regulatory bodies, and the timing thereof, plans for
potential commercial launch of ONS-5010, expectations concerning
the relationship with Cencora 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 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 overseas conflict, 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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