Outlook Therapeutics Completes Patient Enrollment for NORSE 2 Study of ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
July 07 2020 - 8:05AM
Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late
clinical-stage biopharmaceutical company working to develop the
first FDA-approved ophthalmic formulation of bevacizumab for use in
retinal indications, today announced the completion of patient
enrollment in its NORSE 2 clinical trial for ONS-5010 / LYTENAVA™
(bevacizumab-vikg), an investigational ophthalmic formulation of
bevacizumab for use in retinal indications.
“We are extremely grateful to the patients and
medical staff who continue to take part in this study, even amidst
the effects of the COVID-19 pandemic. The hard work and dedication
shown by these individuals have made it possible for us to achieve
this important milestone, which now starts the clock to the
completion of the study and to our reporting of pivotal data,
expected in the third calendar quarter of 2021,” commented Lawrence
A. Kenyon, President, CEO and CFO of Outlook Therapeutics.
The NORSE 2 clinical trial commenced patient
enrollment in July 2019. Due to the number of patients in screening
at the time of achieving the trial’s stated goal of enrolling 220
patients in the study, Outlook Therapeutics has enrolled 227
patients at 39 clinical trial sites in the United States. Patients
in the trial are being treated for 12 months. The primary endpoint
for NORSE 2 is the difference in proportion of patients who gain at
least 15 letters in the best corrected visual acuity (BCVA) at 11
months for ONS-5010 dosed on a monthly basis, compared to
LUCENTIS®, which is being dosed quarterly per the PIER regimen.
Outlook Therapeutics expects to report pivotal safety and efficacy
data in the third calendar quarter of 2021. “Within the retina
community, the use of anti-VEGF therapy continues to be the
standard of care for many ophthalmic diseases. Given the high cost
of the present FDA-approved anti-VEGF therapies, many physicians
have turned to off-label repackaged bevacizumab supplied by
compounding pharmacists. There is significant unmet patient need
for an FDA-approved bevacizumab for use in treating retinal
diseases. I believe that LYTENAVA™, if approved, will offer
clinicians an important new safe and effective, on-label anti-VEGF
therapy option across the spectrum of retinal care,” commented Mark
Humayun M.D., Medical Advisor for Outlook Therapeutics.
Outlook Therapeutics intends to complete
development of ONS-5010 for submission to the FDA as a new BLA
under the 351(a) PHSA regulatory pathway for the treatment of wet
AMD and also has plans to submit for regulatory approvals in Europe
and Japan, as well as other countries.
If approved, ONS-5010 will be the first and only
on-label ophthalmic formulation of bevacizumab for treating retinal
diseases and has the potential to address a $9.1 billion anti-VEGF
market. 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 two adequate and well-controlled
registration clinical trials for wet AMD (NORSE 1 and NORSE 2) and,
if successful, is expected to be submitted to the FDA as a new BLA
for this ophthalmic indication under the 351(a) regulatory pathway.
If approved, ONS-5010 will be the first and only FDA-approved
ophthalmic formulation of bevacizumab to treat retinal diseases.
Outlook Therapeutics currently intends to commercialize ONS-5010 in
both vials and single-use pre-filled syringes.
ONS-5010 is a full-length, humanized anti-VEGF
(Vascular Endothelial Growth Factor) recombinant monoclonal
antibody (mAb) that inhibits VEGF and associated angiogenic
activity. With wet AMD, abnormally high levels of VEGF are
secreted in the eye. VEGF is a protein that promotes the growth of
new abnormal blood vessels. 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 the first FDA-approved
ophthalmic formulation of bevacizumab for use in retinal
indications, including wet AMD, DME and BRVO. If ONS-5010 /
LYTENAVA™ (bevacizumab-vikg), its investigational ophthalmic
formulation of bevacizumab, is approved, Outlook Therapeutics
expects to commercialize it as the first and only approved
ophthalmic formulation of bevacizumab for use in treating approved
retinal diseases in the United States, 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,
NORSE 2, ONS-5010’s potential as the first FDA-approved ophthalmic
formulation of bevacizumab, including benefits therefrom to
patients, payors and physicians, 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, 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.
For additional details on Outlook Therapeutics’
financial performance during the quarter, please see the Outlook
Therapeutics filings with the Securities and Exchange
Commission.
CONTACTS: Outlook
Therapeutics: Lawrence A. Kenyon
LawrenceKenyon@outlooktherapeutics.com
Investor Inquiries: Jenene Thomas Chief
Executive Officer JTC Team, LLC T:
833.475.8247OTLK@jtcir.com
Media Inquiries:Jessica MorrisAccount
ExecutiveLaVoie Health ScienceM:
857-701-9731jmorris@lavoiehealthscience.com
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