Outlook Therapeutics Reports Final Visit for Last Patient in Open-Label Safety Study for ONS-5010/LYTENAVA™ (bevacizumab-vi...
February 11 2021 - 7:05AM
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 that the last patient
completed their final visit for the ongoing open-label safety study
evaluating ONS-5010/LYTENAVA™ (bevacizumab-vikg) to treat retinal
diseases (NORSE THREE).
Two of the three planned clinical trials for the
ONS-5010 / LYTENAVA™ wet age-related macular degeneration (wet AMD)
U.S. Biologics License Application (BLA) are now completed. The
open-label safety study enrolled 197 subjects, in only 4 weeks,
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 (IVT) doses of ONS-5010 /
LYTENAVA™. The data from this study is expected to be reported in
the second quarter of calendar 2021 and will be included in the
complete data package to support the planned BLA for wet AMD, on
schedule for submission to the U.S. Food and Drug Administration
(FDA) in the fourth quarter of calendar 2021.
“We sincerely thank the clinicians and study
participants for their commitment and dedication to completing this
safety study in this ongoing pandemic environment. The NORSE THREE
study plays a key role in our overall ONS-5010 registration
program. With the last patient visit now completed in this study,
we are focused on the successful completion and data readout for
the pivotal NORSE TWO Phase 3 study of ONS-5010 for the treatment
of wet AMD, followed by our planned BLA submission,” added Lawrence
A. Kenyon, President, CEO and CFO, Outlook Therapeutics.
Following the data readout from both the
open-label safety study and the pivotal safety and efficacy study,
Outlook Therapeutics plans to submit a new BLA filing to the FDA
under the PHSA 351(a) regulatory pathway. If the BLA is approved,
it will result in 12 years of marketing exclusivity for
ONS-5010.
Commercial launch planning has begun, including
distribution, physician and patient outreach, key opinion leader
support and payor community engagement. 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 retinal
indications.
In addition to the clinical development plan
evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received
agreements from the FDA on three Special Protocol Assessments
(SPAs) for three additional registration clinical trials. These
SPAs cover the protocols for a planned registration clinical trial
evaluating ONS-5010 to treat BRVO (NORSE FOUR), and two planned
registration clinical trials evaluating ONS-5010 for the treatment
of DME (NORSE FIVE and NORSE SIX). Outlook Therapeutics expects to
initiate registration clinical trials for ONS-5010 for DME and BRVO
later in 2021.
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, China 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 “intend,” “will,” “potential,”
“may,” “might,” “should,” “expect,” “plan,” “anticipate,”
“project,” “believe,” “estimate,” “predict” or “continue,” the
negative of terms like these or other comparable terminology, and
other words or terms of similar meaning. These include statements
about timing of data from ongoing clinical trials of ONS-5010,
timing of BLA submission, expectations regarding marketing
exclusivity, market acceptance, ONS-5010’s ability to meet a
clinical and market need, ONS-5010’s potential as the first
FDA-approved ophthalmic formulation of bevacizumab-vikg,
commercialization if approved, initiation of clinical trials in
other indications, 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 funding such ongoing
development, as well as those risks detailed in Outlook
Therapeutics’ filings with the Securities and Exchange Commission.
These risks, which include the uncertainty of future impacts
related to the ongoing COVID-19 pandemic, 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:
833.475.8247OTLK@jtcir.com
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