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 initiation and
enrollment of the first patients in its planned supplemental
open-label safety study evaluating ONS-5010 / LYTENAVA™
(bevacizumab-vikg) for the treatment of wet age-related macular
degeneration (AMD) (NORSE THREE).
The open-label safety study is being conducted
to ensure that an adequate number of safety exposures to ONS-5010 /
LYTENAVA™ (bevacizumab-vikg) are available to support Outlook
Therapeutics’ initial Biologics License Application (BLA) filing
for wet AMD with the U.S. Food and Drug Administration (FDA). In
total, approximately 180 patients with a wide range of different
retinal diseases for which an anti-VEGF drug can be used as a
therapeutic option, including wet AMD, diabetic macular edema (DME)
and branch retinal vein occlusion (BRVO), are expected to be
enrolled. Patients in the safety study will receive three doses of
ONS-5010 over a three-month period.
“The initiation of this open-label safety study,
the third clinical trial in our wet AMD program, is an important
step in our overall development plan for ONS-5010. This study is
intended to ensure that enough patients have been treated with
ONS-5010 in our streamlined clinical program to support submission
for a new BLA,” said Lawrence Kenyon, President, CEO and CFO of
Outlook Therapeutics. “With both this supplemental safety study and
our fully enrolled pivotal Phase 3 trial moving towards completion
in the first half of 2021, we remain on track to report the full
complement of data needed for our new BLA filing for wet AMD in the
third quarter of 2021.”
The data from this supplemental safety study,
the results from a previously completed clinical experience trial,
which demonstrated anticipated safety and efficacy as well as
positive proof-of-concept, and the data from the ongoing, fully
enrolled pivotal Phase 3 trial will form the complete data set
required for a potential new BLA filing for the treatment of wet
AMD in the second half of 2021.
While unapproved repackaged IV bevacizumab from
compounding pharmacies is already widely used in treating retinal
diseases, ONS-5010, if approved, will be the first on-label
injectable ophthalmic formulation of bevacizumab-vikg for the
treatment of wet AMD and other retinal diseases; it will offer a
new approved anti-VEGF treatment option across the spectrum of
retinal care, currently estimated to be over $13 billion globally
for anti-VEGF therapies. In addition to working towards a new BLA
filing under the 351(a) PHSA regulatory pathway, Outlook
Therapeutics is also engaged with regulatory authorities in Europe
and other major markets for anticipated approvals in those markets.
In addition to seeking regulatory approval for treating wet AMD,
Outlook Therapeutics intends to initiate registration clinical
trials for ONS-5010 for DME and BRVO.
Commercial launch planning for ONS-5010 is
ongoing, 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 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. 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. ONS-5010 is
currently being evaluated in a Phase 3 clinical trial for wet AMD
and, if successful, is expected to be filed with the FDA as a new
BLA for this ophthalmic indication under the 351(a) regulatory
pathway. 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.
If approved, ONS-5010 will be the first and only
FDA-approved ophthalmic formulation of bevacizumab-vikg to treat
retinal diseases. Outlook Therapeutics currently intends to
commercialize ONS-5010 in both vials and single-use pre-filled
syringes.
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
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. 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 the
timing of completion of, and pivotal safety and efficacy data from,
the pivotal Phase 3 trial, ONS-5010’s potential as the first
FDA-approved ophthalmic formulation of bevacizumab-vikg, including
benefits therefrom to patients, payors and physicians, the timing
of BLA submission and sufficiency of exposures to support such
submission, 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:Jessica MorrisAccount ExecutiveLaVoie Health
ScienceT: 857.701.9731jmorris@lavoiehealthscience.com
Investor Inquiries:Jenene ThomasChief Executive
OfficerJTC Team, LLCT: 833.475.8247 OTLK@jtcir.com
Outlook Therapeutics (NASDAQ:OTLK)
Historical Stock Chart
From Feb 2024 to Mar 2024
Outlook Therapeutics (NASDAQ:OTLK)
Historical Stock Chart
From Mar 2023 to Mar 2024