Harrow Announces Availability of Fortisite™ Formulations for In-Office Use
January 05 2023 - 7:00AM
Business Wire
Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical
company, today announced the availability, for in-office use, of
Fortisite™ (compounded Tobramycin 1.5% + Vancomycin 5%) from its
FDA‑registered and FDA‑inspected ImprimisRx® 503B outsourcing
facility. Fortisite formulations are patent-pending
high-concentration, refrigeration-stable, fortified antibiotic
formulations, in solution. The availability of Fortisite for
in-office use represents the first time eyecare professionals have
been able to stock a fortified or high-concentration compounded
antibiotic formulation for the immediate treatment of patients in
need.
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Fortisite, available from Harrow's
ImprimisRx 503B outsourcing facility. (Photo: Business Wire)
ImprimisRx offers a robust Fortisite patient access program and
a 100% replacement guarantee for any expired 503B Fortisite
product, ensuring all prescribing U.S. eyecare professionals can
continuously stock Fortisite formulations in their offices. Eyecare
professionals can order Fortisite online or call ImprimisRx
Customer Care at (844) 446-6979.
In commenting on the announcement, Mark L. Baum, Chairman and
Chief Executive Officer of Harrow, said, “The availability of
Fortisite formulations will provide eyecare professionals with new
and important tools in their pharmaceutical armamentarium as they
consider how to treat potentially sight-threatening infections.
Until there is an FDA-approved product to meet these needs,
Fortisite formulations have the potential to become the standard of
care for ophthalmology and optometry practices across the
country.
“Because Fortisite is now available for in-office use from our
FDA-registered 503B outsourcing facility, each bottle must strictly
adhere to rigorous analytical testing protocols that are not
required for locally regulated 503A compounding pharmacies.”
Comments from eyecare professionals regarding Fortisite (none of
whom are consultants to Harrow):
- At a recent panel discussion at the annual Ocular Surgery News
(OSN) New York conference, Dr. Eric Donnenfeld, an internationally
recognized refractive and cataract surgeon at Ophthalmic
Consultants of Long Island, NY, said, “Every ophthalmologist who
has an anterior segment practice should have Fortisite available in
their refrigerator for that ounce of protection you need on that
Friday afternoon for that patient that comes in with infection that
you say, ‘what do I do next?’ To have this available from Harrow’s
ImprimisRx [division] is a really nice thing to have.”
- Dr. Brian Shafer, a cataract, refractive, cornea, and glaucoma
surgeon with Chester County Eye Care, added, “The commercial
availability of Fortisite is truly a game changer in the management
of certain serious infectious eye diseases. Gone are the days of
sending patients to compounding pharmacies hours away. Now, we can
provide patients with the care they need and deserve directly from
the office refrigerator!”
- Dr. Terrence O’Brien, distinguished professor of ophthalmology
at Bascom Palmer Eye Institute, said, “Topical broad-spectrum
ophthalmic antibacterial agents are an essential therapy for
severe, sight-threatening ocular infections. Finally, a reliable
source for stable, commercially available, shelf-ready potent
formulations for immediate application is changing traditional
access and reliability challenges while allowing more rapid
achievement of microbicidal concentrations in ocular tissues for
potentially enhancing treatment response.”
Compounded medications are not reviewed by the FDA for safety or
efficacy. ImprimisRx does not compound copies of commercially
available products.
PLEASE REVIEW THE FORTISITE PACKAGE INSERT
BEFORE USING.
About Harrow
Harrow (Nasdaq: HROW) is a leading U.S. eyecare pharmaceutical
company that serves eyecare professionals by providing both branded
FDA-approved and innovative compounded prescription medicines that
are accessible and affordable. Harrow meets its mission by serving
ophthalmologists and optometrists as they protect the gift of sight
for their patients. For more information about Harrow, please visit
the Investors section of the corporate website, harrow.com.
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 website 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230105005349/en/
Investors Jamie Webb
Director of Communications and Investor Relations
jwebb@harrowinc.com 615-733-4737
Media Deb Holliday Holliday
Communications, Inc. deb@hollidaycommunications.net
412-877-4519
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