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, following receipt of written confirmation of
the NORSE EIGHT proposed clinical trial protocol with the U.S. Food
and Drug Administration (FDA), Outlook Therapeutics has submitted a
Special Protocol Assessment (SPA) request for the required
additional adequate and well-controlled study of ONS-5010.
As previously announced, following the Type A
meeting with the FDA held in October 2023, the FDA 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 efficacy endpoint at 2 months.
Subsequently, as discussed with and recommended by the FDA, Outlook
Therapeutics submitted a clinical trial protocol and requested a
Type A meeting with the FDA for feedback. The FDA has since
provided written feedback on the protocol, which Outlook
Therapeutics has incorporated. The revised protocol is the subject
of the SPA request, in which Outlook Therapeutics is seeking
further confirmation from the FDA that NORSE EIGHT, if successful,
addresses the FDA’s requirement for a second adequate and
well-controlled clinical trial to support the resubmission of the
ONS-5010 BLA for wet AMD. The FDA is expected to provide a response
to the SPA in early February 2024.
NORSE EIGHT will be a randomized, controlled,
parallel-group, masked study of neovascular age-related macular
degeneration subjects randomized in a 1:1 ratio to receive 1.25 mg
ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects
will receive injections at Day 0 (randomization), Week 4, and Week
8 visits. Approximately 400 patients are expected to be enrolled in
the study.
Outlook Therapeutics expects to resubmit the
ONS-5010 BLA by the end of calendar year 2024 to include the
results of NORSE EIGHT and the additional CMC work to address the
issues identified by FDA in the Complete Response Letter issued in
August 2023 to support approval.
“We have been working closely with FDA to meet
the remaining requirements provided by the Agency to support
approval of ONS-5010. Based on our ongoing discussions with FDA, we
believe we have agreement on a clinical trial protocol. With the
SPA now submitted, we are preparing to start NORSE EIGHT in the
first quarter of 2024,” commented Russell Trenary, President and
Chief Executive Officer of Outlook Therapeutics. “We remain
dedicated in our pursuit to achieve U.S. FDA approval for the first
ophthalmic formulation of bevacizumab and look forward to providing
further updates.”
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 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. 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, expectations concerning the NORSE EIGHT trial design, the
timing for initiation and 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.
Investor
Inquiries: Jenene
ThomasChief Executive OfficerJTC Team, LLCT:
833.475.8247 OTLK@jtcir.com
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