Leading Ophthalmology Organization Launches Podcast Video with Firas Rahhal, MD, to Explore the Genesis and Promise of Outloo...
January 12 2021 - 8:05AM
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, announces the release of a podcast
video produced by the Ophthalmology Innovation Summit (OIS)
featuring Firas Rahhal, MD, a partner at Retina-Vitreous Associates
Medical Group and Associate Clinical Professor of Ophthalmology at
the UCLA School of Medicine and two members of Outlook
Therapeutics’ management team, Terry Dagnon, Chief Operating
Officer, and Jeff Evanson, Chief Commercial Officer. The interview,
led by Dr. Rahhal, discusses how and why Outlook Therapeutics is
advancing its investigational compound ONS-5010, now in Phase 3
clinical trials, towards filing with the Food and Drug
Administration (FDA) as the first approved and cGMP-manufactured
ophthalmic formulation of bevacizumab designed to meet the needs of
the retina community.
The clinical value of bevacizumab in treating
retinal disease is already well established, based on prior
research and nearly 15 years of clinical use. However, to date
clinicians who wish to use it as a less expensive alternative to
the costly approved drugs, EYLEA®, LUCENTIS® and BEOVU®, must use
off-label repackaged IV bevacizumab (Avastin®) from compounding
pharmacies because no FDA-approved ophthalmic formulation of
bevacizumab is currently available.
“There is a real clinical and market need for an
approved bevacizumab that is manufactured in a cGMP facility and
falls within the regular drug supply chain. In my practice we
currently use off-label repackaged IV bevacizumab for approximately
half my wet AMD patients, which makes me very interested to learn
more about the development of an FDA-approved ophthalmic
bevacizumab such as ONS-5010 that I could use,” said Dr. Rahhal.
“It was great to hear from seasoned biopharma industry
professionals about the strategy behind their clinical development
program for such a noteworthy product.”
In the podcast video, Mr. Dagnon and Mr. Evanson
explain how Outlook Therapeutics intends to meet this clinical and
market need with ONS-5010, which if approved will offer clinicians
and their retina patients a safe and efficacious, cGMP-produced
bevacizumab in the estimated $13 billion global market for
anti-VEGF retina therapies. Outlook Therapeutics expects to
commercialize ONS-5010, if approved, under a responsible pricing
policy, bringing a win-win-win to clinicians, patients and payors.
Outlook Therapeutics’ initial BLA filing with the FDA will be for
treatment of wet AMD, expected in the second half of this year.
Additional clinical trials are planned for indications in diabetic
macular edema (DME) and branch retinal vein occlusion (BRVO).
“On behalf of Outlook Therapeutics, Jeff and I
want to thank OIS and Dr. Rahhal for spearheading this insightful
podcast on our clinical development program for ONS-5010,” said
Terry Dagnon, COO of Outlook Therapeutics. “We are tremendously
excited by the opportunity to have a significant positive impact on
retina patients’ lives around the world and to work with retina
thought leaders like Dr. Rahhal and OIS to raise awareness of this
potential new therapy in the retina community.”
The full podcast video is available on the OIS
Website here.
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 (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, China 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 and the podcast video to
which it relates contain 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 “intend,” “will,” “potential,” “may,” “might,” “should,”
“expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,”
“predict” or “continue,” the negative of terms like these or other
comparable terminology, and other words or terms of similar
meaning. These include statements about ONS-5010’s ability to meet
a clinical and market need, ONS-5010’s potential as the first
FDA-approved ophthalmic formulation of bevacizumab-vikg,
commercialization and pricing of ONS-5010 if approved, the timing
of BLA submission, clinical trials in other indications, , 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:
833.475.8247 OTLK@jtcir.com
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