Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late
clinical-stage biopharmaceutical company working to develop the
first FDA-approved ophthalmic formulation of bevacizumab-vikg for
use in retinal indications, today announced the creation of its
Global Retina Advisory Council. Mark Humayun, MD, PhD, has agreed
to act as Chairman of the Advisory Council and Firas Rahhal, MD,
has agreed to join him as an inaugural member.
The Global Retina Advisory Council is being
established by Outlook Therapeutics to ensure that it has access to
guidance and advice on all relevant topics from a group of
pre-eminent global specialists in retinal medicine. Outlook
Therapeutics intends to include additional expert advisors from
around the world as it advances its ongoing clinical program and
pre-commercialization planning for ONS-5010/LYTENAVA™
(bevacizumab-vikg), an investigational ophthalmic formulation of
bevacizumab for treatment of wet age-related macular degeneration
(wet AMD) and other retinal diseases.
“As we expand our pre-commercialization
activities in anticipation of our planned BLA filing for ONS-5010
to treat wet AMD in mid-2021, collaborating with leading experts in
the retinal field will be critical to lay the groundwork for the
eventual adoption by the clinical community,” said Lawrence Kenyon,
President, CEO and CFO of Outlook Therapeutics. “We thank Drs.
Humayun and Rahhal for agreeing to join us to help bring the first
approved ophthalmic formulation of bevacizumab to market. We
anticipate that ONS-5010, if approved, will address the potential
issues that retinal clinicians and their patients currently
experience with unapproved repackaged IV bevacizumab from
compounding pharmacists.”
Mark Humayun, MD, PhD, is Medical Advisor at
Outlook Therapeutics and a recognized retinal specialist worldwide,
with over 250 publications and more than 125 issued patents. Over
the course of his career, Dr. Humayun has received several research
awards, including the 2005 Innovator of the Year award (R&D
magazine) and more recently the 2020 Medal for Innovations in
Healthcare Technology (Institute of Electrical and Electronics
Engineers). He also has been recognized for his clinical work,
voted by U.S. News and World Report as one of the top 1% of
Ophthalmologists in America. Most notably, in 2016 Dr. Humayun
received the National Medal of Technology and Innovation from
President Barack Obama for his innovative work on bioengineered
implants including the development of the Argus II, the world’s
first FDA-approved artificial retinal prosthesis.
Firas Rahhal, MD, is a partner at
Retina-Vitreous Associates Medical Group in Los Angeles and is an
Associate Clinical Professor of Ophthalmology at the UCLA School of
Medicine – Jules Stein Eye Institute. He has published dozens of
scientific papers and is a frequent presenter at major
international scientific meetings. He has extensive expertise in
advancing clinical development programs, having been an
investigator in over 100 national or international trials, many of
which led to novel therapies for vitreo-retinal diseases. Dr.
Rahhal has been consistently named “Top Doctor” by his physician
peers in the Los Angeles Magazine annual review. He is Board
Certified by the American Board of Ophthalmology and is a member of
the American Academy of Ophthalmology, the American Society of
Retina Specialists, and The Retina Society. He is Co-Director of
the RVA-USC Joint Vitreoretinal Fellowship training program.
“I am honored to be the Chairman of the Global
Retina Advisory Council and look forward to working closely with
Dr. Rahhal and the Outlook Therapeutics management team to advance
Outlook Therapeutics’ clinical program for ONS-5010 for the
treatment of retina indications. The potential for an FDA-approved
ophthalmic formulation of bevacizumab would be a significant
addition to the retinal treatment armamentarium, and is anticipated
to provide physicians a safe, approved formulation of a drug they
are already using off-label in more than 50% of all wet AMD cases,”
added Dr. Humayun.
Outlook Therapeutics’ clinical program for
ONS-5010 is on track to report pivotal Phase 3 data in mid-2021,
with an expected new Biologics License Application (BLA) to be
submitted to the U.S. Food and Drug Administration (FDA) for
treatment of wet AMD in the second half of next year. If all goes
as planned, Outlook Therapeutics anticipates FDA approval for
ONS-5010 in mid-2022 as the first and only approved bevacizumab to
treat wet AMD. In addition to the planned BLA filing in the United
States, Outlook Therapeutics is also engaged with regulatory
authorities in Europe and other major markets for anticipated
approvals in those markets. Outlook Therapeutics also intends to
initiate registration clinical trials for ONS-5010 for DME and
BRVO.
With an enhanced safety and cost-effectiveness
profile, Outlook Therapeutics expects ONS-5010, if approved, to be
widely adopted by payors and clinicians worldwide and to become the
first-line drug of choice for payor-mandated “step edit” in the
United States for retinal indications. Outlook Therapeutics is also
engaged with several life sciences companies that could result in a
strategic partnership and definitive agreement for ONS-5010 as soon
as the end of 2020.
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. 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 pharmacists, products that have known risks
of contamination and inconsistent potency and availability. If
approved, ONS-5010 will reduce the need for use of unapproved
repackaged IV bevacizumab from compounding pharmacists for retinal
disease.
ONS-5010 is a full-length, humanized anti-VEGF
(Vascular Endothelial Growth Factor) recombinant monoclonal
antibody (or mAb) that inhibits VEGF and associated angiogenic
activity. VEGF is a protein that promotes the growth of new
abnormal blood vessels. With wet AMD, abnormally high levels of
VEGF are secreted in the eye and lead to loss of vision. 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 ONS-5010/LYTENAVA™
(bevacizumab-vikg) as the first FDA-approved ophthalmic formulation
of bevacizumab-vikg for use in retinal indications, including wet
AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics
expects to commercialize it as the first and only FDA-approved
ophthalmic formulation of bevacizumab-vikg for use in treating a
range of retinal diseases in the United States, United Kingdom,
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, initially for wet AMD. 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 “potential,” “may,” “might,”
“will,” “should,” “expect,” “plan,” “anticipate,” “project,”
“believe,” “estimate,” “predict,” “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 potential benefits of establishing the Global Retina Advisory
Council, ONS-5010’s potential as the first FDA-approved ophthalmic
formulation of bevacizumab-vikg, including benefits therefrom to
patients, payors and physicians, the ability of ONS-5010 to gain
widespread acceptance in the retinal treatment community, the
timing of completion of, and pivotal safety and efficacy data from,
the pivotal Phase 3 trial, the timing of BLA submission and
sufficiency of exposures to support such submission, statements
about 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, risks in obtaining
necessary regulatory approvals, and risks of funding such ongoing
development, 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.
CONTACTS:
Media Inquiries:
Harriet UllmanAssistant Vice PresidentLaVoieHealthScienceT:
617-669-3082hullman@lavoiehealthscience.com
Investor Inquiries:
Jenene ThomasChief Executive OfficerJTC Team, LLCT:
833.475.8247OTLK@jtcir.com
Outlook Therapeutics (NASDAQ:OTLK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Outlook Therapeutics (NASDAQ:OTLK)
Historical Stock Chart
From Apr 2023 to Apr 2024