Contract Enhances Purchasing Power for 340B
Prime Vendor Program (PVP) Participants; Aligns with Harrow’s
Mission to Make Its Products Accessible and Affordable
Harrow (Nasdaq: HROW), a leading North American eyecare
pharmaceutical company, today announced that as of July 1, 2024, it
has entered into an agreement with Apexus to make IHEEZO®
(chloroprocaine hydrochloride ophthalmic gel) 3% and other Harrow
products available through its 340B Prime Vendor Program. IHEEZO,
indicated for ocular anesthesia, is a low-viscosity topical ocular
anesthetic gel with reliable efficacy, a proven safety profile, and
simple administration. Other Harrow products available through the
program include VIGAMOX®, a topical eye drop for bacterial
conjunctivitis, and ILEVRO®, an ocular nonsteroidal
anti-inflammatory (NSAID) topical eye drop for pain and
inflammation.
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In commenting on the agreement, Mark L. Baum, Chairman and Chief
Executive Officer of Harrow, said, “We believe the value this
agreement provides to eligible participants will open access to
IHEEZO for the U.S. hospital market. According to the U.S. Centers
for Disease Control and Prevention, approximately 2.4 million
annual emergency room visits in U.S. hospitals are due to
eye-related problems, including the removal of foreign bodies and
other acute conditions, many of which require anesthetizing the
eye. Consistent with our commitment to ensure access and
affordability to our products, with around 44% of U.S. hospitals
participating in the Apexus 340B Prime Vendor Program, we are
thrilled about the potential benefits we see from our new
relationship, especially for vulnerable populations.”
The 340B Prime Vendor Program, managed by Apexus, is a contract
awarded by the Health Resources and Services Administration
(“HRSA”), an agency of the U.S. Department of Health and Human
Services, which is responsible for administering the 340B Drug
Pricing Program. As the Prime Vendor, Apexus contracts with
manufacturers and distributors to help ensure access to discounted
medications, provides 340B education to all stakeholders, and helps
support program integrity through technical assistance.
About Harrow
Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical
company engaged in the discovery, development, and
commercialization of innovative ophthalmic pharmaceutical products
for the North American market. Harrow helps eyecare professionals
preserve the gift of sight by making its portfolio of prescription
and non-prescription pharmaceutical products accessible and
affordable to millions of patients 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, among others, risks related to: liquidity or
results of operations; our ability to successfully implement our
business plan, develop and commercialize our products, product
candidates and proprietary formulations in a timely manner or at
all, identify and acquire additional products, manage our pharmacy
operations, service our debt, obtain financing necessary to operate
our business, recruit and retain qualified personnel, manage any
growth we may experience and successfully realize the benefits of
our previous acquisitions and any other acquisitions and
collaborative arrangements we may pursue; competition from
pharmaceutical companies, outsourcing facilities and pharmacies;
general economic and business conditions, including inflation and
supply chain challenges; regulatory and legal risks and
uncertainties related to our pharmacy operations and the pharmacy
and pharmaceutical business in general; physician interest in and
market acceptance of our current and any future formulations and
compounding pharmacies generally. 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 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.
About
IHEEZO® (chloroprocaine hydrochloride ophthalmic gel)
3%
- 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 was approved by the FDA on September 26, 2022.
- Clinical trials of IHEEZO demonstrated that patients treated
with IHEEZO did not require any supplemental treatment to complete
the intended surgical procedure.
- 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.
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. IHEEZO™ 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 complete product information about IHEEZO®, including
important safety information, please visit:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea3b2d2c-8b33-d199-e053-2995a90a699c.
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 ILEVRO® (nepafenac ophthalmic
suspension) 0.3%
ILEVRO® (nepafenac ophthalmic suspension) 0.3%, a nonsteroidal,
anti-inflammatory eye drop indicated for pain and inflammation
associated with cataract surgery.
INDICATIONS AND USAGE
ILEVRO® 0.3% is indicated for the treatment of pain and
inflammation associated with cataract surgery.
CONTRAINDICATIONS
ILEVRO® 0.3% is contraindicated in patients with previously
demonstrated hypersensitivity to any of the ingredients in the
formula or to other nonsteroidal anti-inflammatory drugs
(NSAIDs).
WARNINGS AND PRECAUTIONS
Increased Bleeding Time. With some NSAIDs including ILEVRO®
0.3%, there exists the potential for increased bleeding time due to
interference with thrombocyte aggregation. There have been reports
that ocularly applied nonsteroidal anti-inflammatory drugs may
cause increased bleeding of ocular tissues (including hyphema) in
conjunction with ocular surgery. It is recommended that ILEVRO®
0.3% be used with caution in patients with known bleeding
tendencies or who are receiving other medications which may prolong
bleeding time.
Delayed Healing. Topical NSAIDs including ILEVRO® 0.3%, may slow
or delay healing. Topical corticosteroids are also known to slow or
delay healing. Concomitant use of topical NSAIDs and topical
steroids may increase the potential for healing problems.
Corneal Effects. Use of topical NSAIDs may result in keratitis.
In some susceptible patients, continued use of topical NSAIDs may
result in epithelial breakdown, corneal thinning, corneal erosion,
corneal ulceration, or corneal perforation. These events may be
sight threatening. Patients with evidence of corneal epithelial
breakdown should immediately discontinue use of topical NSAIDs
including ILEVRO® 0.3% and should be closely monitored for corneal
health.
Postmarketing experience with topical NSAIDs suggests that
patients with complicated ocular surgeries, corneal denervation,
corneal epithelial defects, diabetes mellitus, ocular surface
diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat
ocular surgeries within a short period of time may be at increased
risk for corneal adverse events, which may become sight
threatening. Topical NSAIDs should be used with caution in these
patients. Postmarketing experience with topical NSAIDs also
suggests that use more than 1 day prior to surgery or use beyond 14
days post-surgery may increase patient risk and severity of corneal
adverse events.
Contact Lens Wear. ILEVRO® 0.3% should not be administered while
using contact lenses.
ADVERSE REACTIONS
Because clinical studies are conducted under widely varying
conditions, adverse reaction rates observed in the clinical studies
of a drug cannot be directly compared to the rates in the clinical
studies of another drug and may not reflect the rates observed in
practice.
Serious and Otherwise Important Adverse Reactions. The following
adverse reactions are discussed in greater detail in other sections
of labeling: (1) Increased Bleeding Time, (2) Delayed Healing and
(3) Corneal Effects.
Ocular Adverse Reactions. The most frequently reported ocular
adverse reactions following cataract surgery were capsular opacity,
decreased visual acuity, foreign body sensation, increased
intraocular pressure, and sticky sensation. These reactions
occurred in approximately 5 to 10% of patients. Other ocular
adverse reactions occurring at an incidence of approximately 1 to
5% included conjunctival edema, corneal edema, dry eye, lid margin
crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular
pruritus, photophobia, tearing and vitreous detachment. Some of
these reactions may be the consequence of the cataract surgical
procedure.
Non-Ocular Adverse Reactions. Non-ocular adverse reactions
reported at an incidence of 1 to 4% included headache,
hypertension, nausea/vomiting, and sinusitis.
For complete product information about ILEVRO®, including
important safety information, please visit:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10f411d3-a81e-074a-e063-6294a90ab547.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240709623740/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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