Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late
clinical-stage biopharmaceutical company working to develop the
first FDA-approved ophthalmic formulation of bevacizumab-vikg for
use in retinal indications, today announced the completion of
patient enrollment for its planned open-label safety study
evaluating ONS-5010/LYTENAVA™ (NORSE THREE). Patient enrollment for
the study was completed in less than one month, significantly ahead
of the planned four-month enrollment schedule.
The open-label safety study enrolled 195
subjects with a range of retinal diseases for which an anti-VEGF
drug is a therapeutic option, including wet age-related macular
degeneration (AMD), diabetic macular edema (DME) and branch retinal
vein occlusion (BRVO). Subjects enrolled in the study are receiving
three monthly intravitreal (IVT) doses of ONS-5010/LYTENAVA™. The
data from this study will be included in the complete data package
to support the planned Biologics License Application (BLA) for wet
AMD, on schedule for submission to the United States Food and Drug
Administration (FDA) in the second half of 2021.
“I am delighted to see the enthusiasm for
ONS-5010 that our clinical trial investigators have shown and their
ability to rapidly enroll patients. The expedited manner in which
enrollment was completed strengthens our confidence that an
FDA-approved ophthalmic formulation of bevacizumab represents a
significant unmet need in the ophthalmic community,” said Mark
Humayun, MD, PhD, Medical Advisor to Outlook Therapeutics.
While unapproved repackaged IV bevacizumab from
compounding pharmacies is already widely used in treating retinal
diseases, ONS-5010, if approved, will be the first and only
on-label ophthalmic formulation of bevacizumab-vikg for the
treatment of wet AMD. It will offer a new, approved treatment
option for wet-AMD, in the estimated $13 billion global market for
anti-VEGF retina therapies.
“On behalf of the entire Outlook Therapeutics
team, I would like to express our deep appreciation to the
dedicated clinicians conducting this safety study as part of our
ONS-5010 registration program,” added Lawrence Kenyon, President,
CEO and CFO, Outlook Therapeutics. “The speed with which we
completed enrollment in this safety study tells us a lot about the
confidence of physicians and patients in ONS-5010. We believe that
we remain well-positioned to file a new BLA for wet AMD as planned
in 2021, now that all three of the planned clinical trials have
either been completed or are fully enrolled.”
In addition to the planned BLA filing in the
United States, Outlook Therapeutics is also engaged with regulatory
authorities in Europe and other major markets for anticipated
approvals in those markets. Outlook Therapeutics also intends to
initiate registration clinical trials for ONS-5010 for DME and
BRVO.
Commercial launch planning for ONS-5010,
including distribution, physician and patient outreach, key opinion
leader support and payor community engagement, remains
ongoing. With an enhanced safety and cost-effectiveness
profile, Outlook Therapeutics expects ONS-5010, if approved, to be
widely adopted by payors and clinicians worldwide and to become the
first-line drug of choice for payor-mandated “step edit” in the
United States for retina indications. Outlook Therapeutics is also
engaged with several life sciences companies that could result in a
strategic partnership and definitive agreement for ONS-5010 as soon
as the end of 2020.
About ONS-5010 /
LYTENAVA™ (bevacizumab-vikg)
ONS-5010 / 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. 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 pharmacists, products that have known risks
of contamination and inconsistent potency and availability. If
approved, ONS-5010 will reduce the need for use of unapproved
repackaged IV bevacizumab from compounding pharmacists for retinal
disease.
ONS-5010 is a full-length, humanized anti-VEGF
(Vascular Endothelial Growth Factor) recombinant monoclonal
antibody (or mAb) that inhibits VEGF and associated angiogenic
activity. VEGF is a protein that promotes the growth of new
abnormal blood vessels. With wet AMD, abnormally high levels of
VEGF are secreted in the eye and lead to loss of vision. 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 ONS-5010/LYTENAVA™
(bevacizumab-vikg) as the first FDA-approved ophthalmic formulation
of bevacizumab-vikg for use in retinal indications, including wet
AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics
expects to commercialize it as the first and only FDA-approved
ophthalmic formulation of bevacizumab-vikg for use in treating a
range of retinal diseases in the United States, United Kingdom,
Europe, Japan and other markets. Outlook Therapeutics expects to
file ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a)
regulatory pathway, initially for wet AMD. 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 “expect,” “will,” “could,” “may,”
“might,” “should,” “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 the timing of completion of, and pivotal safety and efficacy
data from, the pivotal Phase 3 trial, the timing of BLA submission,
sufficiency of exposures and clinical trials conducted to support
such submission, ONS-5010’s potential as the first FDA-approved
ophthalmic formulation of bevacizumab-vikg, including benefits
therefrom to patients, payors and physicians, statements about
commercial launch of ONS-5010, the timing of entry into a strategic
partnership and definitive agreement with a global ophthalmic
company, including its ability to do so, 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, risks in obtaining
necessary regulatory approvals, and risks of negotiating strategic
partnership agreements, as well as those risks detailed in Outlook
Therapeutics’ filings with the Securities and Exchange Commission,
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 UllmanAssistant Vice
PresidentLaVoieHealthScienceT:
617-669-3082hullman@lavoiehealthscience.com
Investor
Inquiries: Jenene
ThomasChief Executive OfficerJTC Team, LLCT:
833.475.8247 OTLK@jtcir.com
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