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 announced that the U.S. Food and Drug
Administration (FDA) has accepted for filing a Biologics License
Application (BLA) for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an
investigational ophthalmic formulation of bevacizumab for the
treatment of wet age-related macular degeneration (wet AMD). The
FDA set a Prescription Drug User Fee Act (PDUFA) goal date of
August 29, 2023. ONS-5010, if approved, is expected to receive 12
years of regulatory exclusivity in the United States.
“This BLA acceptance and PDUFA date are
significant milestones in our mission to offer clinicians and their
patients the first and only on-label, ophthalmic bevacizumab to
treat wet AMD,” said Russell Trenary, President and CEO of Outlook
Therapeutics. “If approved, ONS-5010 (bevacizumab-vikg) will meet
the robust FDA requirements for use as an ophthalmic injectable. We
estimate that approximately 50% of the millions of anti-VEGF
injections in ophthalmology are off-label compounded bevacizumab
that is administered with no FDA-approved labeling. That product
configuration does not meet the same standards we must achieve to
earn FDA approval in ophthalmology. We hope to enhance the standard
of care in the anti-VEGF space, and we are proud of the entire team
and our clinical partners and advisors for bringing ONS-5010 to
this point in its journey towards FDA approval.”
“We are pleased the FDA has begun its review of
our application. ONS-5010 is designed and manufactured to be fully
compliant with the FDA’s criteria for ophthalmic intravitreal
biologics and we are excited about the prospect of filling the
public health need for an FDA-approved ophthalmic formulation of
bevacizumab,” added Terry Dagnon, Chief Operations Officer of
Outlook Therapeutics.As part of the Company’s multi-year commercial
planning process, and in anticipation of potential FDA approval in
August 2023, Outlook Therapeutics and AmerisourceBergen recently
announced a strategic commercialization agreement to expand the
Company’s reach for connecting to retina specialists and their
patients. AmerisourceBergen will provide third-party logistics
(3PL) services and distribution, as well as pharmacovigilance
services in the United States. Through this agreement, Outlook
Therapeutics expects to increase market access and efficient
distribution of ONS-5010, while not duplicating services provided
by AmerisourceBergen, thereby decreasing Outlook’s otherwise needed
expense for those same services.
Outlook Therapeutics also established
best-in-class partnerships with FUJIFILM Diosynth Biotechnologies
for drug substance manufacturing, and with drug product
manufacturer Ajinomoto Bio-Pharma Services for finished drug
product.
In addition to the U.S. filing, Outlook
Therapeutics is also developing registration documents on a
parallel path for approvals in Europe and expects to submit them in
the fourth quarter of 2022. Outlook Therapeutics is assessing both
direct commercialization and partnering in Europe and Asia on a
country-by-country basis.
About the NORSE Registration Clinical
Program for Wet AMD
NORSE ONE was a clinical experience trial
involving 61 wet AMD participants at nine trial sites in Australia.
NORSE ONE compared ONS-5010 to ranibizumab (LUCENTIS®) as a
treatment for wet AMD and showed the first markers of efficacy and
safety in humans for ONS-5010 ophthalmic bevacizumab. In the trial,
ONS-5010 efficacy and safety data were consistent with historical
published studies of bevacizumab in ophthalmology, and NORSE ONE
also supported the trial design and inclusion/exclusion criteria
for NORSE TWO, the pivotal Phase 3 registration clinical trial. The
NORSE TWO Phase 3 pivotal trial enrolled a total of 228 wet AMD
patients at 39 clinical trial sites in the United States. It
was designed as a superiority study comparing the safety and
efficacy of ONS-5010 ophthalmic bevacizumab dosed monthly against
ranibizumab (LUCENTIS®) dosed according to the PIER dosing regimen
described in the LUCENTIS® label. The trial data met both the
primary and secondary endpoints with high statistical significance
and clinical relevance. For its primary endpoint, 41.7% (p =
0.0052) of patients gained ≥ 15 letters of vision, and for its
secondary endpoints, 56.5% (p = 0.0016) of patients gained ≥ 10
letters of vision and 68.5% (p = 0.0116) gained ≥ 5 letters. The
key secondary endpoint, mean change in BCVA from baseline to Month
11, was 11.2 letters gained (p = 0.0043) compared to 5.8 letters
gained in the ranibizumab arm. The NORSE TWO data also showed that
the drug was well-tolerated, consistent with previously reported
data for ONS-5010 and prior research. NORSE THREE was an open-label
safety study of ONS-5010 in 197 patients conducted in the United
States to provide the necessary number of retina patients dosed
with ONS-5010 to complete the safety requirements for the BLA
submission.
Safety results across the first three NORSE
trials demonstrated a strong benefit-to-risk safety profile. Across
all three ONS-5010 registration trials, there was only one ocular
inflammation adverse event, which was reported in NORSE TWO; the
event was treated topically and resolved without sequelae. The most
common adverse reaction (≥ 5%) reported in patients receiving
ONS-5010 was conjunctival hemorrhage associated with the needle
injection procedure (5%). About ONS-5010 / LYTENAVA™
(bevacizumab-vikg) ONS-5010 is an
investigational ophthalmic formulation of bevacizumab under
development 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 can
replace the need to use unapproved repackaged oncologic IV
bevacizumab from compounding pharmacies for the treatment of wet
AMD. Bevacizumab-vikg is a recombinant humanized
monoclonal antibody (mAb) that selectively binds with high affinity
to all isoforms of human vascular endothelial growth factor (VEGF)
and neutralizes VEGF’s biologic activity through a steric blocking
of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR
(VEGFR-2) on the surface of endothelial cells. Following
intravitreal injection, the binding of bevacizumab-vikg to VEGF
prevents the interaction of VEGF with its receptors on the surface
of endothelial cells, reducing endothelial cell proliferation,
vascular leakage, and new blood vessel formation in the
retina.
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. The FDA accepted Outlook Therapeutics’ BLA submission
for ONS-5010 to treat wet AMD with a PDUFA goal date of August 29,
2023. The submission is supported by Outlook Therapeutics’ wet AMD
clinical program, which consists of three clinical trials: NORSE
ONE, NORSE TWO, and NORSE THREE. 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. 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 “anticipate,”
“estimate,” “expect,” “intend,” “may,” “might,” “plan,”
“potential,” “predict,” “project,” “should,” “will,” 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, expectations concerning
market exclusivity, Outlook’s partnership with AmerisourceBergen,
the services to be provided thereunder and the anticipated benefits
thereof, Outlook’s expected commercial reach, market access and
distribution network, the timing of a commercial launch of
ONS-5010, plans for regulatory submissions and potential launch in
international markets, plans for submission of an sBLA and the
related NORSE SEVEN clinical trial, and other statements that are
not historical fact. 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, 2021, as supplemented by its Quarterly
Report on Form 10-Q for the quarter ended June 30, 2022, 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:Anna ArmyAccount
SupervisorLaVoie Health ScienceT:
617-351-0246aarmy@lavoiehealthscience.com
Investor Inquiries:Jenene ThomasChief Executive
OfficerJTC Team, LLCT: 833-475-8247 OTLK@jtcir.com
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