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 submitted its
Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) for ONS-5010, an investigational therapy
which, if approved, will be branded as LYTENAVA™
(bevacizumab-vikg), for the treatment of wet age-related macular
degeneration (wet AMD). If approved, LYTENAVA™ (bevacizumab-vikg)
could replace the current practice of using unapproved repackaged
IV bevacizumab sourced from compounding pharmacies for the
treatment of wet AMD.“This BLA submission for our investigational
ONS-5010 not only marks a very significant moment for Outlook
Therapeutics, but represents a real step forward for potentially
providing an on-label, FDA-approved alternative for the most
frequently used anti-VEGF treatment in wet AMD patients in the
United States,” said Russ Trenary, President and Chief Executive
Officer, Outlook Therapeutics. “If approved for marketing, we hope
to see our ophthalmic bevacizumab become a valuable on-label
therapy offering clinicians and their patients a safe and effective
ophthalmic formulation of a treatment whose value has been proven
over many years of clinical practice. We are excited for the
potential to offer an ophthalmic bevacizumab formulation that ships
straight from our factory partners to distribution centers while
avoiding the risks of using unapproved repackaged IV bevacizumab
that is approved for intravenous use but not for intravitreal
administration.”
In anticipation of potential FDA marketing
approval in late 2022 or early 2023, Outlook Therapeutics has begun
commercial launch planning, including best-in-class partnerships
with FUJIFILM Diosynth Biotechnologies for drug substance, and with
drug product manufacturer Aji Biopharma Services for finished drug
product. The Company also is actively building out its distribution
and commercial team structures.
“The significant efficacy results we are
submitting from our NORSE TWO Phase 3 pivotal trial demonstrated
the one-, two- and three-line visual acuity responders one would
hope for in a pivotal wet AMD trial,” according to Terry Dagnon,
Chief Operations Officer with Outlook Therapeutics. “Additionally,
given the need to address the potential public health concerns
related to repackaged IV bevacizumab, we are submitting the
important integrated safety data from our NORSE registration
clinical program. While noting reported ocular inflammation safety
data from other recent product development efforts in wet AMD, we
are very excited to be submitting our safety dossier. We observed a
total of one ocular inflammation adverse event (iritis) reported
from our three completed NORSE clinical studies. When normalizing
this single event to the large number of ONS-5010 injections in our
clinical trials, it occurred at a 0.05% incidence.”
“The retina community is very excited about a
potential on-label treatment option of bevacizumab and the data we
have seen from Outlook Therapeutics makes this a real treatment
option for us upon FDA approval,” said Firas M. Rahhal, MD,
Retina-Vitreous Associates Medical Group, Assoc. Clinical Professor
of Ophthalmology, UCLA School of Medicine.
About the NORSE Registration Clinical
Program for Wet AMD The BLA 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.
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 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 a superiority trial design comparing the safety and
efficacy of ONS-5010 ophthalmic bevacizumab dosed monthly against
ranibizumab (LUCENTIS®) dosed according to the PIER dosing regimen
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 also met: mean change in BCVA from baseline
to Month 11, which was 11.2 letters gained (p = 0.0043). The NORSE
TWO data also showed a strong safety profile 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 of
the BLA.
Safety results across the 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 related to the 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.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 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 “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, and the timing of commercial launch of ONS-5010.
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, 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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