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 presented pivotal safety and
efficacy data from the Phase 3 NORSE TWO trial for ONS-5010, an
investigational ophthalmic formulation of bevacizumab for use in
wet age-related macular degeneration (wet AMD) and other retinal
indications, at the Retinal Subspecialty Day, AAO 2021 Annual
Conference.
The data presentation “Safety and Efficacy
Results of ONS-5010, as Ophthalmic Bevacizumab, Phase 3 Pivotal
Study of Monthly Intravitreal OS-5010 in Subjects with Wet AMD
(NORSE TWO)” was given during Section X: Late Breaking
Developments, Part II by Firas M. Rahhal, MD, Retina-Vitreous
Associates Medical Group, Assoc. Clinical Professor of
Ophthalmology, UCLA School of Medicine.
“If approved by the FDA, ONS-5010 will become
the first and only on-label ophthalmic bevacizumab, which is very
significant for thousands of patients needing anti-VEGF treatments
to control their wet AMD,” said Dr. Rahhal. “It will be great for
patients and their doctors to have more FDA-approved anti-VEGF
options that are prepared specifically for intraocular use.”
The NORSE TWO Phase 3 pivotal trial enrolled a
total of 228 wet AMD patients at 39 clinical trial sites
in the United States. NORSE TWO was a superiority trial
comparing the safety and efficacy of ONS-5010 ophthalmic
bevacizumab dosed monthly against ranibizumab (LUCENTIS®) dosed
according to the PIER regimen in the Lucentis labeling.
Participants in the trial were treated for 12 months, with the
primary endpoint at Month 11 being the difference in proportion of
patients who gained at least 15 letters (3 lines) in best corrected
visual acuity (BCVA). The key secondary endpoint was the mean
change in BCVA from baseline to Month 11. NORSE TWO data showed a
strong safety profile, results consistent with previously reported
safety data for ONS-5010, and similar to safety levels reported in
prior research for bevacizumab used off-label in ophthalmology.
The NORSE TWO pivotal data met both primary and
secondary endpoints with statistically significant and clinically
relevant results:
- 41.7% (p = 0.0052) ONS-5010 subjects gained ≥ 15 letters of
vision
- 56.5% (p = 0.0016) ONS-5010 subjects gained ≥ 10 letters of
vision
- 68.5% (p = 0.0116) ONS-5010 subjects gained ≥ 5 letters of
vision
- ONS-5010 subjects gained 11.2 letters (p = 0.0043) in BCVA
Results from NORSE TWO also demonstrated that
ONS-5010 ophthalmic bevacizumab has a strong safety profile. In
findings that are consistent with historical bevacizumab data
reported in prior research, in all three ONS-5010 registration
trials there was only one ocular inflammatory adverse event, which
was treated topically and resolved without sequelae. The safety
findings continue to support minimal ocular inflammation and safety
signals consistent with what was previously reported in the 2011
CATT trial (National Eye Institute) and other large
bevacizumab-controlled ophthalmic studies.
“With the positive results from NORSE TWO, we
are confident that, if approved, ONS-5010 has the potential to
become a valuable new tool in the armamentarium of therapies for
wet AMD. If approved as the first on-label ophthalmic formulation
of bevacizumab, ONS-5010 will enable patients to benefit from wider
access and provide an attractive alternative for anti-VEGF
treatment of wet AMD,” added C. Russell Trenary III, President and
CEO of Outlook Therapeutics. “We are moving ahead with our plans to
submit our BLA for wet AMD with the FDA in the first quarter of
calendar 2022 and working with other global regulatory authorities
to bring this important therapy to market.”
Outlook Therapeutics’ clinical program
investigating ONS-5010 ophthalmic bevacizumab to treat wet AMD
consists of three clinical trials – NORSE ONE, NORSE TWO, and NORSE
THREE – all of which have now been completed. Based on the strong
data from this clinical program, 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 in the US 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 can 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 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 and plans for regulatory
approvals in other markets. 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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