Harrow Launches VIGAMOX® in the U.S.
July 31 2023 - 7:00AM
Business Wire
Harrow (NASDAQ: HROW), a leading U.S. eyecare pharmaceutical
company, today announced the completion of the transfer to Harrow
of the New Drug Application (NDA) for VIGAMOX® (moxifloxacin
hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone
antibiotic eye drop for the treatment of bacterial conjunctivitis
caused by susceptible strains of organisms. The U.S. commercial
rights to VIGAMOX were purchased by Harrow in January of 2023, and
VIGAMOX is the fourth FDA-approved ophthalmic product from that
acquisition to have completed the NDA transfer process and become
commercially available under the Harrow name.
“Having now completed the NDA transfer of VIGAMOX, we are
excited to begin the implementation of the market access,
marketing, inventory management, national sales detailing, and
other brand‑leveraging strategies that we have developed during
this transfer period,” said Mark L. Baum, Chief Executive Officer
of Harrow. “With an exceptional record of safety and efficacy,
VIGAMOX is a well-known, reliable, and trusted product by U.S.
eyecare professionals, many of whom regard VIGAMOX as the preferred
broad-spectrum topical antibiotic to treat patients for bacterial
conjunctivitis (sometimes referred to as 'pink eye') as well as
many other common bacterial-based infections.”
Product orders for VIGAMOX can be made directly through Harrow’s
dedicated customer service ordering partner, Cardinal’s
Cordlogistics, which includes a wholesaler distribution system
encompassing McKesson and AmerisourceBergen.
About VIGAMOX® (moxifloxacin hydrochloride ophthalmic
solution) 0.5%:
INDICATIONS AND USAGE
VIGAMOX® is a topical fluoroquinolone anti-infective indicated
for the treatment of bacterial conjunctivitis caused by susceptible
strains of the following organisms: Corynebacterium species*,
Micrococcus luteus*, Staphylococcus aureus, Staphylococcus
epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis,
Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus
viridans group, Acinetobacter lwoffii*, Haemophilus influenzae,
Haemophilus parainfluenzae*, and Chlamydia trachomatis.
*Efficacy for this organism was studied in fewer than 10
infections.
IMPORTANT SAFETY INFORMATION
Contraindications
VIGAMOX® is contraindicated in patients with a history of
hypersensitivity to moxifloxacin, to other quinolones, or to any of
the components in this medication.
Warnings and Precautions
- Hypersensitivity Reactions – Hypersensitivity and anaphylaxis
have been reported with systemic use of moxifloxacin.
- Prolonged Use – May result in overgrowth of non-susceptible
organisms, including fungi.
- Avoid Contact Lens Wear – Patients should not wear contact
lenses if they have signs or symptoms of bacterial
conjunctivitis.
Adverse Reactions
The most frequently reported ocular adverse events were
conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular
discomfort, ocular hyperemia, ocular pain, ocular pruritus,
subconjunctival hemorrhage, and tearing. These events occurred in
approximately 1%-6% of patients.
Nonocular adverse events reported at a rate of 1%-4% were fever,
increased cough, infection, otitis media, pharyngitis, rash, and
rhinitis.
For complete product information about VIGAMOX®, including
important safety information, please visit:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ad783689-2b59-448c-b0d6-e8b70cf8b062.
About Harrow
Harrow Health, Inc. (Nasdaq: HROW) is a leading eyecare
pharmaceutical company engaged in the discovery, development, and
commercialization of innovative ophthalmic pharmaceutical products
for the U.S. market. Harrow helps U.S. eyecare professionals
preserve the gift of sight by making its comprehensive portfolio of
prescription and non-prescription pharmaceutical products
accessible and affordable to millions of Americans each year. For
more information about Harrow, please visit 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 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/20230731229519/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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