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 the results from its
NORSE THREE supplemental safety study evaluating ONS-5010 /
LYTENAVA™ (bevacizumab-vikg) at the 39th Annual Meeting of the
American Society of Retina Specialists in San Antonio, Texas. As
previously reported, topline data from the NORSE THREE open-label
study of ONS-5010 ophthalmic bevacizumab demonstrated no unexpected
safety trends and had a safety profile consistent with those of
other trials of ONS-5010 as well as prior published data such as
that undertaken by the National Eye Institute (e.g., 2011 CATT
trial).
Suber Huang, MD, MBA, FASRS, Founder and CEO of
the Retina Center of Ohio and presenter at the 39th Annual Meeting
of the American Society of Retina Specialists, said “I am excited
to see that in the NORSE THREE trial the safety profile of ONS-5010
ophthalmic bevacizumab reinforces what has been previously reported
in other studies of ONS-5010 as well as in earlier published
research on the use of bevacizumab in ophthalmology. If approved,
ONS-5010 will offer retina specialists the first safe and
effective, on-label bevacizumab that avoids the potentially serious
adverse events associated with off-label repackaged IV bevacizumab
from compounding pharmacies. I hope to see it become an important
new weapon in our therapeutic armamentarium.”
The three-month NORSE THREE safety study, which
was conducted to ensure that an adequate number of subjects with
retinal disease had been dosed with ONS-5010 to support Outlook
Therapeutics’ planned BLA submission to the U.S. Food and Drug
Administration (FDA), enrolled 197 treatment-naïve and previously
treated subjects who suffered from a variety of retinal conditions
for which an anti-VEGF therapy is appropriate, such as wet
age-related macular degeneration (wet AMD), diabetic macula edema
(DME) and branch retinal vein occlusion (BRVO). Participants
received three monthly intravitreal doses of ONS-5010 ophthalmic
bevacizumab. The study examined the frequency and incidence of
adverse events as well as any changes in safety parameters.
Data from NORSE THREE indicated that in this
study ONS-5010 showed no intraocular inflammation or vasculitis,
and the frequency and incidence of adverse events and ocular
adverse events were low. The most common adverse event in the study
eye was conjunctival hemorrhage related to injection procedure, not
to ONS-5010, and there were no additional serious adverse events
associated with these injections. NORSE THREE showed no
unanticipated safety signals.
"The strong safety results from NORSE THREE
reinforce the safety profile seen across all three NORSE clinical
trials for ONS-5010 and reflect the consistent safety observed both
in decades of real-world clinical practice and in prior published
research on the use of bevacizumab in ophthalmology,” said C.
Russell Trenary, President and CEO, Outlook Therapeutics. “With our
wet AMD clinical program investigating ONS-5010 as the first
ophthalmic formulation of bevacizumab to be potentially approved to
treat retinal conditions now complete, we are actively preparing
our BLA, and we expect to file it with the FDA in early 2022. If
approved, we believe ONS-5010 has the potential to make a
significant impact in the retina community and to address the need
for an approved ophthalmic bevacizumab.”
Outlook Therapeutics’ wet AMD ONS-5010 clinical
program for the planned BLA submission consists of three clinical
trials, NORSE ONE, NORSE TWO, and NORSE THREE, all of which have
now been completed. In early August, Outlook Therapeutics reported
positive topline data from its NORSE TWO pivotal Phase 3 clinical
trial. In NORSE TWO, ONS-5010 achieved statistically significant
and clinically relevant primary (p = 0.0052) and key secondary (p =
0.0043) efficacy endpoints with 41% of subjects gaining at least 15
letters of BVCA. ONS-5010 was also found to be safe and well
tolerated in the NORSE TWO trial.
With the registration clinical trials now
completed, 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 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 will 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 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, 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, plans for regulatory approvals
in other markets, and plans for future clinical trials. 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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