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 it has re-submitted its
Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) for ONS-5010, an investigational ophthalmic
therapy which, if approved, will be branded as LYTENAVA™
(bevacizumab-vikg) for the treatment of wet age-related macular
degeneration (wet AMD).
“Over the past three months, we have worked
diligently to provide the additional required information that was
not included in our March 2022 BLA submission, to address requests
from the Agency to ensure our BLA is complete for acceptance and
review. We believe that this re-submission addresses each of the
comments and recommendations from the Agency, and we are confident
in the revised BLA application,” said Russell Trenary, President
and CEO of Outlook Therapeutics. “We remain committed to bringing
ophthalmic bevacizumab to market, which if approved, can provide
retina patients with an on-label treatment option that helps
patients avoid the health risks associated with unapproved
repackaged oncologic IV bevacizumab.”
“Our NORSE TWO pivotal trial for ONS-5010 showed
compelling efficacy and clinical relevance coupled with a robust
safety profile, and we are confident that our investigational drug,
if approved, will be a valuable therapeutic option to treat retina
diseases,” added Terry Dagnon, Chief Operations Officer of Outlook
Therapeutics. “ONS-5010 is designed and manufactured to be fully
compliant with FDA’s criteria for ophthalmic biologics to meet the
public health need for an FDA-approved ophthalmic formulation of
bevacizumab.”
In anticipation of potential FDA marketing
approval in 2023, Outlook Therapeutics has continued its commercial
launch planning. These activities include establishing
best-in-class partnerships with FUJIFILM Diosynth Biotechnologies
for drug substance, and with drug product manufacturer Ajinomoto
Bio-pharma Services for finished drug product. Outlook Therapeutics
is also actively building out its distribution and commercial
capabilities.
About the NORSE Registration Clinical
Program for Wet AMD The BLA re-submission is based on the
totality of data from Outlook Therapeutics’ wet AMD clinical
program for ONS-5010, which consists of three completed
registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE
– as well as a Phase 1 pharmacokinetic clinical trial and the
necessary pre-clinical testing.
NORSE ONE was a clinical experience trial
involving 61 wet AMD participants at nine trial sites in Australia.
It compared ONS-5010 to ranibizumab (LUCENTIS®) as a treatment for
wet AMD. NORSE ONE 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. NORSE ONE also
supported the trial design and inclusion/exclusion criteria
established 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 their primary and secondary
endpoints with high statistical significance and clinical
relevance. For its primary endpoint, 41.7% (p = 0.0052) of patients
gained at least 15 letters of vision, and for its secondary
endpoints 56.5% (p = 0.0016) of subjects gained ≥ 10 letters of
vision and 68.5% (p = 0.0116) gained at least 5 letters. The key
secondary endpoint was met: mean change in BCVA from baseline to
Month 11, which was 11.2 letters gained compared to 5.8 letters
gained in the ranibizumab arm (p = 0.0043). 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 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%). These safety findings continue to support
minimal ocular inflammation and safety signals consistent with what
was previously reported in the 2011 CATT trial (National Eye
Institute) and other large adequate and well-controlled ophthalmic
studies of bevacizumab.
As previously announced, if ONS-5010 receives
FDA approval, Outlook Therapeutics plans to submit a supplementary
application (sBLA) for approval to provide the product in a
pre-filled syringe that is free from liquid silicone oils and that
meets the FDA’s specifications for ophthalmic use. To support the
anticipated submission of this sBLA, Outlook Therapeutics is
conducting its NORSE SEVEN clinical trial to compare the safety of
ONS-5010 in vials versus ONS-5010 in pre-filled syringes. NORSE
SEVEN is expected to enroll approximately 120 subjects with visual
impairment due to retinal disorders. Patients will be treated for
three months, and patient enrollment in the arm of the study
receiving ONS-5010 in vials has already been
completed.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 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), an investigational therapy, as the first
FDA-approved ophthalmic formulation of bevacizumab for use in
retinal indications, including wet AMD, DME and BRVO. Outlook
Therapeutics has submitted its Biologics License Application (BLA)
to the U.S. Food and Drug Administration (FDA) for ONS-5010 to
treat wet AMD. The submission is supported by Outlook Therapeutics’
wet AMD registration 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 StatementsThis
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,” “believe,” “continue,” “could,” “estimate,”
“expect,” “may,” “might,” “intend,” “potential,” “predict,”
“should,” or “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, including benefits therefrom to patients, payors
and physicians, the potential approval and commercial launch of
ONS-5010 and the timing thereof, plans for additional clinical
trials and regulatory submissions, 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: 833.475.8247OTLK@jtcir.com
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