Outlook Therapeutics Presents Positive NORSE THREE Safety Data for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) at EURETINA Virtual 2021 Medical Conference
September 13 2021 - 8:05AM
Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical
company working to develop and launch the first FDA-approved
ophthalmic formulation of bevacizumab for use in
retinal indications, today announced the presentation of
safety data from the NORSE THREE trial evaluating ONS-5010 /
LYTENAVA™ (bevacizumab-vikg) at the EURETINA Virtual 2021
conference on September 12, 2021. The previously announced topline
results from the open-label safety study demonstrated that ONS-5010
ophthalmic bevacizumab, under evaluation for the treatment of wet
AMD, showed no unexpected safety trends and had a safety profile
consistent with that of prior published data undertaken by the
National Eye Institute (2011 CATT trial).
“ONS-5010 has the potential to close the gap on
a high unmet need for patients and retinal clinicians,” said
Professor Timothy L. Jackson, PhD, MB ChB FRCOphth, Ophthalmic and
Retinal Surgeon and Professor of Retinal Research at King’s College
London and data presenter at EURETINA. “If approved, ONS-5010
ophthalmic bevacizumab may improve clinical outcomes of patients
with wet AMD while potentially avoiding serious adverse events
associated with off-label repackaging of IV bevacizumab, including
variability in potency, eye infections and loss of sight.”
The NORSE THREE study was conducted to ensure an
adequate number of patients with wet AMD and other retinal diseases
had been dosed with ONS-5010 to support Outlook Therapeutics’
planned new biologics license application (BLA) submission in the
United States and for other global regulatory filings. The
open-label study met its goal of ensuring that a sufficient number
of individuals have now been treated with ONS-5010 by enrolling 197
treatment-naïve and previously treated subjects with a range of
retinal diseases for which an anti-VEGF drug is a therapeutic
option, including wet AMD, diabetic macular edema (DME) and branch
retinal vein occlusion (BRVO). Subjects enrolled in the study
received three monthly intravitreal doses of ONS-5010 ophthalmic
bevacizumab.
“ONS-5010 has been rigorously tested to support
our efforts to provide the first approved ophthalmic formulation of
bevacizumab,” said C. Russell Trenary III, President and Chief
Executive Officer, Outlook Therapeutics. “With the trial data and
market insight seen to date, we believe ONS-5010 has the potential
to become the cornerstone of care for multiple retinal indications
and we look forward to working closely with the U.S. Food and Drug
Administration and other global regulatory authorities toward our
goal of bringing this important therapy to market.”
Outlook Therapeutics’ wet AMD ONS-5010 clinical
program for the planned BLA submission consists of three clinical
trials, NORSE ONE, NORSE TWO, and NORSE THREE, all of which have
now been completed. Most recently, Outlook Therapeutics reported
positive topline data from its NORSE TWO pivotal Phase 3 clinical
trial. In NORSE TWO, ONS-5010 achieved statistically significant
and clinically relevant primary (p = 0.0052) and key secondary (p =
0.0043) efficacy endpoints with 41% of subjects gaining at least 15
letters of BVCA. ONS-5010 was also found to be safe and well
tolerated in the NORSE TWO trial.
With the registration clinical trials now
completed, Outlook Therapeutics plans to submit a new BLA under the
Public Health Service Act (PHSA) 351(a) regulatory pathway in the
first quarter of calendar 2022. If the BLA is approved, it is
expected to result in 12 years of marketing exclusivity for
ONS-5010 as the first and only ophthalmic formulation of
bevacizumab approved by the FDA to treat wet AMD.
About ONS-5010 / LYTENAVA™
(bevacizumab-vikg)
ONS-5010 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. Because no currently approved ophthalmic
formulations of bevacizumab are available, 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 will replace the
need to use unapproved repackaged IV bevacizumab from compounding
pharmacies for the treatment of wet AMD.ONS-5010 is a full-length,
humanized anti-VEGF (Vascular Endothelial Growth Factor)
recombinant monoclonal antibody (mAb) that inhibits VEGF and
associated angiogenic activity. VEGF is a protein that
promotes the growth of abnormal new blood vessels and promotes
leakage from these vessels, leading to retinal edema and
hemorrhage. With wet AMD, abnormally high levels of VEGF are
secreted in the eye and lead to loss of vision. Anti-VEGF injection
therapy treats the vision-threatening leakage and hemorrhage as
well as blocks the growth of the abnormal blood vessels. 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 biopharmaceutical
company working to develop and launch 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. Outlook Therapeutics expects to
submit ONS-5010 ophthalmic bevacizumab to the U.S. FDA as a new BLA
under the PHSA 351(a) regulatory pathway. 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, among others,
statements about ONS-5010’s potential as the first FDA-approved
ophthalmic formulation of bevacizumab-vikg, including benefits
therefrom to patients, payors and physicians, including
expectations of market exclusivity, the timing of BLA submission
and commercial launch of ONS-5010, plans for regulatory approvals
in other markets, and plans for future clinical trials. 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, as
well as those risks detailed in Outlook Therapeutics’ filings with
the Securities and Exchange Commission, including the Annual Report
on Form 10-K for the fiscal year ended September 30, 2020, as
amended, and subsequent Quarterly Reports on Form 10-Q, which
include the uncertainty of future impacts related to the ongoing
COVID-19 pandemic. 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 PresidentLaVoie Health
ScienceT: 617-669-3082hullman@lavoiehealthscience.com
Investor Inquiries:Jenene ThomasChief Executive
OfficerJTC Team, LLCT: 833.475.8247 OTLK@jtcir.com
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