Outlook Therapeutics Announces LYTENAVA™ (bevacizumab-vikg), Anticipated Brand Name for ONS-5010, If Approved
March 05 2020 - 8:00AM
Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late
clinical-stage biopharmaceutical company working to develop the
first FDA-approved ophthalmic formulation of bevacizumab for use in
retinal indications, today announced that it has received U.S. Food
and Drug Administration (FDA) tentative approval of the Tradename
for ONS-5010 as LYTENAVA™ (bevacizumab-vikg). The Tradename is
conditionally approved by FDA and will be subject to further review
at the time of the Company’s planned filing of a new biologics
license application (BLA) with the FDA for LYTENAVA™
(bevacizumab-vikg) in 2021.
About LYTENAVA™ (bevacizumab-vikg)
LYTENAVA™ (bevacizumab-vikg) 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. LYTENAVA™
(bevacizumab-vikg) is currently being evaluated in two adequate and
well-controlled registration clinical trials for wet AMD (NORSE 1
and NORSE 2) and, if successful, is expected to be submitted to the
FDA as a new BLA for this ophthalmic indication. If approved,
LYTENAVA™ (bevacizumab-vikg) would be the first and only
FDA-approved ophthalmic formulation of bevacizumab to treat retinal
diseases. The Company currently intends to commercialize LYTENAVA™
(bevacizumab-vikg) in both vials and single-use pre-filled
syringes.
LYTENAVA™ (bevacizumab-vikg) is a full-length,
humanized anti-VEGF (Vascular Endothelial Growth Factor)
recombinant monoclonal antibody (or mAb) that inhibits VEGF
and associated angiogenic activity. With wet AMD, abnormally
high levels of VEGF are secreted in the eye. VEGF is a protein that
promotes the growth of new abnormal blood vessels. Anti-VEGF
injection therapy blocks this growth. 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 late clinical-stage
biopharmaceutical company working to develop the first FDA-approved
ophthalmic formulation of bevacizumab for use in retinal
indications, including wet AMD, DME and BRVO. If LYTENAVA™
(bevacizumab-vikg), its investigational ophthalmic formulation of
bevacizumab, is approved, Outlook Therapeutics expects to
commercialize it as the first and only on-label approved ophthalmic
formulation of bevacizumab for use in treating retinal diseases in
the United States, 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 “may,” “might,” “will,” “should,”
“expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,”
“predict,” “potential,” “intend” or “continue,” the negative of
terms like these or other comparable terminology, and other words
or terms of similar meaning. These include statements about plans
for filing a BLA for LYTENAVA™ (bevacizumab-vikg), plans for
offering LYTENAVA™ (bevacizumab-vikg) in unit-dose vials and
pre-filled syringes, FDA approval of LYTENAVA™ (bevacizumab-vikg),
and the benefits of having an FDA approved bevacizumab. Although
the Company believes that it has a reasonable basis for
forward-looking statements contained herein, they are based on
current expectations about future events affecting the Company 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 the Company’s filings with the
Securities and Exchange Commission. 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.
The Company 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.
For additional details on the Company’s financial performance
during the quarter, please see the Company’s filings with
the Securities and Exchange Commission.
CONTACTS: Outlook
Therapeutics:
Lawrence A. Kenyon LawrenceKenyon@outlooktherapeutics.com
Media Inquiries:Emmie TwomblyMedia Relations
SpecialistLaVoie Health ScienceM:
857.389.6042etwombly@lavoiehealthscience.com
Investor
Inquiries:
Jenene Thomas Chief Executive Officer JTC Team, LLC T:
833.475.8247OTLK@jtcir.com
Outlook Therapeutics (NASDAQ:OTLK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Outlook Therapeutics (NASDAQ:OTLK)
Historical Stock Chart
From Apr 2023 to Apr 2024