IHEEZO™ Represents the First Approved Use in
the U.S. Ophthalmic Market of Chloroprocaine Hydrochloride and the
First Branded Ocular Anesthetic Approved for the U.S. Ophthalmic
Market in Nearly 14 Years
IHEEZO™ was Licensed by Harrow for the U.S.
and Canadian Markets From 100-Year-Old International Pharmaceutical
Company Sintetica, S.A.
Harrow (Nasdaq: HROW), an eyecare pharmaceutical company
exclusively focused on the discovery, development, and
commercialization of innovative ophthalmic therapies, and
Sintetica, S.A., a growing pharmaceutical company focused on
analgesics, local anesthetics, and sterile injectable solutions,
today jointly announced the U.S. Food and Drug Administration (FDA)
approval of IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel)
3% for ocular surface anesthesia. IHEEZO is a sterile,
single-patient‑use, physician‑administered, ophthalmic gel
preparation, containing no preservatives, that is safe and
effective for ocular surface anesthesia. IHEEZO represents the
first approved use in the U.S. ophthalmic market of chloroprocaine
hydrochloride and the first branded ocular anesthetic approved for
the U.S. ophthalmic market in nearly 14 years. IHEEZO is protected
by an Orange Book-listed patent that is valid until 2038.
“On behalf of all our ophthalmic physician partners and the
patients they serve, we and our partners at Sintetica are grateful
to the FDA for a New Drug Application (NDA) review process that
resulted in the approval of IHEEZO in advance of our PDUFA target
action date,” said Mark L. Baum, Harrow Chairman and Chief
Executive Officer. “We have always believed in the unique clinical
value of IHEEZO, and now that IHEEZO is approved for use in the
U.S. market, it has the potential to become an indispensable
premium tool for eyecare professionals and their patients requiring
ocular surface anesthesia.”
Nicola Caronzolo, Sintetica Chief Executive Officer, added, “I
am particularly proud of this important milestone, which
exemplifies the quality of Sintetica’s research and development
groups and our ability to innovate – to be a global pharmaceuticals
leader. I want to give special thanks to our regulatory group, who
while working with the Harrow team, performed extraordinarily well,
resulting in this early U.S. market approval for this important new
medicine.”
The safety and efficacy of IHEEZO were demonstrated in three
human clinical studies. Studies 1 and 2 were randomized,
double-blinded, placebo-controlled studies that evaluated the
effect of IHEEZO on healthy volunteers, and Study 3 was a
randomized, prospective, multi-center, active-controlled,
observer‑masked study that evaluated the administration of IHEEZO
in patients undergoing cataract surgery. Study 3 marks the first
time a U.S. drug candidate was studied in a surgical model for FDA
approval in the ocular surface anesthesia category. This study
demonstrated that IHEEZO not only worked rapidly (about 1 to 1.5
minutes) and provided sufficient anesthesia to successfully perform
the surgical procedure (on average lasting 22 minutes), but
importantly, no patient dosed with IHEEZO required a supplemental
treatment to complete the surgical procedure.
According to a September 2021 report by Market Scope, there are
an estimated 4.5 million cataract surgeries and over 8 million
intravitreal injections performed annually in the U.S., all of
which typically utilize some form of ocular surface anesthesia.
Baum continued, “Harrow currently provides perioperative
medications for a significant number of the U.S. ophthalmic
surgical procedures. We believe our customer base of more than
10,000 ophthalmologists, optometrists, retina specialists,
outpatient hospital facilities, and ambulatory surgery centers will
appreciate the unique clinical value and practice efficiency IHEEZO
offers, including its single‑use packaging format, which according
to the Institute for Safe Medication Practices (ISMP), decreases
the risk of infection and medication errors associated with the use
of communal eye drops.
“We have been planning for the commercial launch of IHEEZO for
over a year, and with our national market access and sales
organization already in place, we are 100% ready. Given our earlier
FDA approval date, we have accelerated our market access strategy
to support a commercial launch date slightly ahead of our
previously planned launch at the May 2023 American Society of
Cataract and Refractive Surgery (ASCRS) meeting in San Diego,
CA.”
About IHEEZO™
(chloroprocaine hydrochloride ophthalmic
gel) 3%
INDICATIONS AND USAGE
IHEEZO™ is indicated for ocular surface anesthesia.
CONTRAINDICATIONS
IHEEZO™ is contraindicated in patients with a history of
hypersensitivity to any component of this preparation.
WARNINGS AND PRECAUTIONS
IHEEZO™ should not be injected or intraocularly administered.
Patients should not touch the eye for at least 10 to 20 minutes
after using an anesthetic as accidental injuries can occur due to
insensitivity of the eye. Prolonged use of a topical ocular
anesthetic may produce permanent corneal opacification and
ulceration with accompanying visual loss. Do not touch the dropper
tip to any surface as this may contaminate the gel. IHEEZOTM is
indicated for administration under the direct supervision of a
healthcare provider. IHEEZO™ is not intended for patient
self-administration.
ADVERSE REACTIONS
The most common adverse reaction is mydriasis (approximately
25%).
For additional information about IHEEZO™, including important
safety information, please see the Full Prescribing
Information.
About Harrow
Harrow (Nasdaq: HROW) is an eyecare pharmaceutical company
exclusively focused on the discovery, development, and
commercialization of innovative ophthalmic therapies that are
accessible and affordable. For more information about Harrow,
including investment-related materials, please visit the corporate
website, harrowinc.com, or Harrow’s LinkedIn page.
About Sintetica
Based in Mendrisio, Switzerland, Sintetica is a growing
privately held international pharmaceutical company focused on
emergency and intensive care, analgesics, local anesthetics and
sterile injectable solutions in ampoules, vials and IV bags for
hospitals. Sintetica develops medicines in concentrated, premixed
and ready-to-use formulations, which enables healthcare
practitioners to administer these products without manipulation and
dilution, increasing patient safety and improving convenience for
patients and HCPs. Sintetica runs sales subsidiaries in selected
European markets and partners with leading distributors around the
world.
Harrow Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this release that are not historical facts
may be considered such “forward-looking statements.”
Forward-looking statements are based on management's current
expectations and are subject to risks and uncertainties which may
cause results to differ materially and adversely from the
statements contained herein. Some of the potential risks and
uncertainties that could cause actual results to differ from those
predicted include the continued impact of the COVID-19 pandemic and
any future health epidemics on our financial condition, liquidity
and results of operations; our ability to make commercially
available our FDA-approved products and compounded formulations and
technologies in a timely manner or at all; market acceptance of the
Company’s products and challenges related to the marketing of the
Company’s products; risks related to our pharmacy operations; our
ability to enter into other strategic alliances, including
arrangements with pharmacies, physicians and healthcare
organizations for the development and distribution of our products;
our ability to obtain intellectual property protection for our
assets; our ability to accurately estimate our expenses and cash
burn, and raise additional funds when necessary; risks related to
research and development activities; the projected size of the
potential market for our technologies and products; unexpected new
data, safety and technical issues; regulatory and market
developments impacting compounding pharmacies, outsourcing
facilities and the pharmaceutical industry; competition; and market
conditions. These and additional risks and uncertainties are more
fully described in Harrow’s filings with the Securities and
Exchange Commission, including its Annual Report on Form 10-K and
its Quarterly Reports on Form 10-Q. Such documents may be read free
of charge on the SEC's web site at www.sec.gov. Undue reliance
should not be placed on forward-looking statements, which speak
only as of the date they are made. Except as required by law,
Harrow undertakes no obligation to update any forward-looking
statements to reflect new information, events, or circumstances
after the date they are made, or to reflect the occurrence of
unanticipated events.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220927005982/en/
Harrow Investors: Jamie Webb Director of Communications and
Investor Relations jwebb@harrowinc.com 615-733-4737
Harrow Media: Deb Holliday Holliday Communications, Inc.
deb@hollidaycommunications.net 412-877-4519
Sintetica Media: Daniele Fontana Sustainability & HR
Corporate Director communications@sintetica.com +41 79 218 90
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