Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial
biopharmaceutical company working to develop and launch the first
FDA-approved ophthalmic formulation of bevacizumab for use in
retinal indications, today announced the appointment of Julia A.
Haller, MD, to the Company’s Board of Directors.
“We are pleased to welcome Dr. Haller to Outlook
Therapeutics’ Board of Directors. As one of the world’s most
accomplished professionals in ophthalmic education, research, and
clinical ophthalmic practice, she will add tremendous value and
insight to Outlook Therapeutics,” said Randy Thurman, Executive
Chairman of the Outlook Therapeutics Board of Directors.
Julia A. Haller, MD, Ophthalmologist-in-Chief at
Wills Eye Hospital and Professor and Chair of Ophthalmology at
Sidney Kimmel Medical College at Thomas Jefferson University, is a
trailblazing retina surgeon-scientist and leader who has innovated
translational advances against blindness that arises from many
retinal diseases. She also combines her deep medical and scientific
expertise with efforts to address healthcare disparities and gender
inequality.
A Board-certified ophthalmologist, Dr. Haller
began her career at the Wilmer Eye Institute at Johns Hopkins
Hospital and as a faculty member of the University. Subsequently
she moved to Wills Eye Hospital in Philadelphia, where she was
appointed Ophthalmologist-in-Chief and William Tasman, MD Endowed
Chair as well as Professor and Chair of Ophthalmology at the Sidney
Kimmel Medical College of Thomas Jefferson University. Her
innovative research has resulted in more than 400 published
scientific articles and book chapters on a range of subjects,
including clinical trials and other advances in retinal
pharmacology.
Dr. Haller commented, “I am delighted with the
therapeutic potential of ONS-5010 and the strategic approach
Outlook Therapeutics has taken in advancing this drug candidate. I
believe ONS-5010 has the potential, when approved, to meet the need
for broader patient access to on-label treatment for wet AMD and
other retinal diseases, and to mitigate the risks to patients
associated with the use of off-label repackaged intravenous
bevacizumab from compounding pharmacies. I am honored to become
part of this endeavor and look forward to working with the Board
and executive leadership team at Outlook Therapeutics.”
“We could not ask for a more accomplished and
respected ophthalmologist and scientist to join our Board of
Directors,” noted C. Russell Trenary, President and CEO of Outlook
Therapeutics. “We welcome Dr. Haller and look forward to her
contributions as we move ONS-5010 towards commercialization and
patient care. She joins the Board at a pivotal and exciting time at
Outlook Therapeutics. Dr. Haller’s expertise aligns perfectly with
our mission to develop therapies that preserve the vision of
patients worldwide.”
Dr. Haller is the distinguished recipient of
numerous honors, including election to the National Academy of
Medicine and awards from all the major ophthalmology and retina
societies. Her honors include the Crystal Apple Award of the
American Society of Retina Specialists for teaching and mentorship,
the Kreissig Award from EURETINA, the President's Award from Women
in Ophthalmology, a Secretariat Award from the AAO, the Gertrude
Pyron Award from the Retina Research Foundation and the ASRS, and a
Lifetime Achievement Award from the AAO. She is past President of
the American Society of Retina Specialists and the Retina Society,
Treasurer of the Macula Society, and former Chair of the Board of
Trustees of the Association of University Professors of
Ophthalmology and the Council of the American Ophthalmological
Society. Dr. Haller serves as Chair of the Board of the College of
Physicians of Philadelphia, Vice Chair of Section 6 of the National
Academy of Medicine, on the Executive Committee of the Board of the
Philadelphia Orchestra and Kimmel Center, and President of the
Johns Hopkins Medicine Alumni Association. She is an emeritus
trustee of Princeton University. She is a member of the editorial
boards of RETINA, Retinal Physician, Ocular Surgery News,
Ophthalmology Times, and Evidence-Based Eye Care.
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 need to use unapproved
repackaged oncologic 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 pre-commercial
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. 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, and
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: 833.475.8247OTLK@jtcir.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/128b9e2a-8277-43ca-a72e-ed703b82487e
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