Harrow Health, Inc. (NASDAQ: HROW), an ophthalmic‑focused
healthcare company, today announced the completion of the transfer
to Harrow of the New Drug Applications (NDAs) of recently acquired,
FDA-approved ophthalmic medicines, IOPIDINE® 1%, MAXITROL®
3.5mg/10,000 units/0.1%, and MOXEZA® 0.5%. Harrow also announced
that IOPIDINE 1% and MAXITROL are now commercially available;
Harrow intends to commercialize MOXEZA 0.5% at a later date. Harrow
purchased these medicines in December 2021 and has been receiving
net profits from unit sales during the NDA transfer process.
“We are pleased to have completed the transfer of the NDAs for
these workhorse products, allowing us to market and sell these
well-known products under the Harrow umbrella,” said Mark L. Baum,
CEO of Harrow Health. “We believe there is strong interest from
physicians and their patients, hospitals, and ambulatory surgery
centers (ASCs) in these products. The transfer of these NDAs gives
Harrow a foundation to begin market access initiatives and lead
conversations with commercial payer decision makers as we continue
to execute our branded ophthalmic pharmaceuticals strategy.”
Product orders for IOPIDINE 1% and MAXITROL can be made directly
through Harrow’s dedicated customer service ordering partner,
Cardinal’s Cordlogistics, which includes a wholesaler distribution
system that encompasses McKesson and AmerisourceBergen.
About IOPIDINE® (apraclonidine hydrochloride ophthalmic
solution) 1%
IOPIDINE 1% Ophthalmic Solution contains apraclonidine
hydrochloride, an alpha-adrenergic agonist, in a sterile isotonic
solution for topical application to the eye.
INDICATIONS AND USAGE
IOPIDINE 1% Ophthalmic Solution is indicated to control or
prevent post-surgical elevations in intraocular pressure (IOP) that
occur in patients after argon laser trabeculoplasty, argon laser
iridotomy, or Nd:YAG posterior capsulotomy.
CONTRAINDICATIONS
IOPIDINE 1% Ophthalmic Solution is contraindicated for patients
receiving monoamine oxidase inhibitor therapy and for patients with
hypersensitivity to any component of this medication or to
clonidine.
WARNINGS
FOR TOPICAL OPHTHALMIC USE ONLY. Not for injection or oral
ingestion.
PRECAUTIONS
General
Patients who develop exaggerated reductions in IOP should be
closely monitored. Caution should be observed in treating patients
with severe cardiovascular disease including hypertension. IOPIDINE
1% Ophthalmic Solution should also be used with caution in patients
with severe coronary insufficiency, recent myocardial infarction,
cerebrovascular disease, chronic renal failure, Raynaud’s disease,
or thromboangiitis obliterans.
The possibility of a vasovagal attack occurring during laser
surgery should be considered and caution used in patients with a
history of such episodes.
Information for Patients
Apraclonidine can cause dizziness and somnolence. Patients who
engage in hazardous activities requiring mental alertness should be
warned of the potential for a decrease in mental alertness on the
day of surgery.
Adverse Reactions
The following adverse events, occurring in less than 2% of
patients, were reported in association with the use of IOPIDINE 1%
Ophthalmic Solution in laser surgery: ocular injection, upper lid
elevation, irregular heart rate, nasal decongestion, ocular
inflammation, conjunctival blanching, and mydriasis.
About MAXITROL® (neomycin and polymyxin B sulfates and
dexamethasone ophthalmic suspension) 3.5mg/10,000
units/0.1%
MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone
ophthalmic suspension) is a multiple dose anti-infective steroid
combination in sterile suspension form for topical application.
INDICATIONS AND USAGE
For steroid-responsive inflammatory ocular conditions for which
a corticosteroid is indicated and where bacterial infection or a
risk of bacterial infection exists. Ocular corticosteroids are
indicated in inflammatory conditions of the palpebral and bulbar
conjunctiva, cornea, and anterior segment of the globe where the
inherent risk of corticosteroids use in certain infective
conjunctivitides is accepted to obtain a diminution in edema and
inflammation. They are also indicated in chronic anterior uveitis
and corneal injury from chemical, radiation, or thermal burns; or
penetration of foreign bodies.
The use of a combination drug with an anti-infective component
is indicated where the risk of infection is high or where there is
an expectation that potentially dangerous numbers of bacteria will
be present in the eye.
The particular anti-infective drug in this product is active
against the following common bacterial eye pathogens:
Staphylococcus aureus, Escherichia coli, Haemophilus influenzae,
Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas
aeruginosa. This product does not provide adequate coverage
against: Serratia marcescens and Streptococci, including
Streptococcus pneumoniae.
CONTRAINDICATIONS
MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone
ophthalmic suspension) is contraindicated in most viral diseases of
the cornea and conjunctiva, including epithelial herpes simplex
keratitis (dendritic keratitis), vaccinia, varicella, and also in
mycobacterial infection of the eye and fungal diseases of ocular
structures. MAXITROL is also contraindicated in individuals with
known or suspected hypersensitivity to any of the ingredients of
this preparation and to other corticosteroids.
WARNINGS
NOT FOR INJECTION. Use of ocular steroids may prolong the course
and may exacerbate the severity of many viral infections of the eye
(including herpes simplex). Employment of a corticosteroid
medication in the treatment of patients with a history of herpes
simplex requires great caution; frequent slit lamp microscopy is
recommended. Prolonged use of corticosteroids may result in
glaucoma with damage to the optic nerve, defects in visual acuity
and fields of vision, and in posterior subcapsular cataract
formation. Prolonged use may also suppress the host immune response
and thus increase the hazard of secondary ocular infections. Acute
purulent or parasitic infections of the eye may be masked or
activity enhanced by the presence of corticosteroid medication.
Various ocular diseases and long-term use of topical
corticosteroids have been known to cause corneal and scleral
thinning. Use of topical corticosteroids in the presence of thin
corneal or scleral tissue may lead to perforation. If this product
is used for 10 days or longer, intraocular pressure (IOP) should be
routinely monitored even though it may be difficult in children and
uncooperative patients. Steroids should be used with caution in the
presence of glaucoma. IOP should be checked frequently.
The use of steroids after cataract surgery may delay healing and
increase the incidence of bleb formation.
MAXITROL® is not for injection. It should never be injected
subconjunctivally, nor should it be directly introduced into the
anterior chamber of the eye. Products containing neomycin sulfate
may cause cutaneous sensitization. Sensitivity to topically
administered aminoglycosides, such as neomycin, may occur in some
patients. The severity of hypersensitivity reactions may vary from
local effects to generalized reactions such as erythema, itching,
urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or
bullous reactions. If hypersensitivity develops during the use of
the product, treatment should be discontinued.
Cross‑hypersensitivity to other aminoglycosides can occur, and the
possibility that patients who become sensitized to topical neomycin
may also be sensitive to other topical and/or systemic
aminoglycosides should be considered.
PRECAUTIONS
General
The initial prescription and renewal of the medication order
beyond 20 mL of MAXITROL® should be made by a physician only after
examination of the patient with the aid of magnification, such as
slit lamp biomicroscopy, and where appropriate, fluorescein
staining. If signs and symptoms fail to improve after two days, the
patient should be reevaluated.
As fungal infections of the cornea are particularly prone to
develop coincidentally with long-term corticosteroid applications,
fungal invasion should be suspected in any persistent corneal
ulceration where a corticosteroid has been used or is in use.
Fungal cultures should be taken when appropriate. Prolonged use of
topical anti-bacterial agents may give rise to overgrowth of
non-susceptible organisms including fungi.
Information for Patients
If inflammation or pain persists longer than 48 hours or becomes
aggravated, the patient should be advised to discontinue the use of
the medication and consult a physician.
This product is sterile when packaged. To prevent contamination,
care should be taken to avoid touching the bottle tip to eyelids or
to any other surface. The use of this bottle by more than one
person may spread infection. Keep the bottle tightly closed when
not in use. Keep out of reach of children.
Patients should be advised that their vision may be temporarily
blurred following dosing with MAXITROL® (neomycin and polymyxin B
sulfates and dexamethasone ophthalmic suspension). Care should be
exercised in operating machinery or driving a motor vehicle.
Adverse Reactions
The reactions due to the corticosteroid component are: elevation
of IOP with possible development of glaucoma, and infrequent optic
nerve damage; posterior subcapsular cataract formation; and delayed
wound healing. Corticosteroid-containing preparations have also
been reported to cause perforation of the globe. Keratitis,
conjunctivitis, corneal ulcers, and conjunctival hyperemia have
occasionally been reported following use of steroids.
Additional adverse reactions identified from post marketing use
include ulcerative keratitis, headache, and Stevens-Johnson
syndrome.
The following additional adverse reactions have been reported
with dexamethasone use: Cushing’s syndrome and adrenal suppression
may occur after use of dexamethasone in excess of the listed dosing
instructions in predisposed patients, including children and
patients treated with CYP3A4 inhibitors.
About MOXEZA® (moxifloxacin ophthalmic solution) 0.5%
MOXEZA® (moxifloxacin ophthalmic solution) is a sterile solution
for topical ophthalmic use.
INDICATIONS AND USAGE
MOXEZA is a topical fluoroquinolone anti-infective indicated for
the treatment of bacterial conjunctivitis caused by susceptible
strains of the following organisms: Aerococcus viridans*,
Corynebacterium macginleyi*, Enterococcus faecalis*, Micrococcus
luteus*, Staphylococcus arlettae*, Staphylococcus aureus,
Staphylococcus capitis, Staphylococcus epidermidis, Staphylococcus
haemolyticus, Staphylococcus hominis, Staphylococcus
saprophyticus*, Staphylococcus warneri*, Streptococcus mitis*,
Streptococcus pneumoniae, Streptococcus parasanguinis*, Escherichia
coli*, Haemophilus influenzae, Klebsiella pneumoniae*,
Propionibacterium acnes, Chlamydia trachomatis.*
*Efficacy for this organism was studied in fewer than 10
infections.
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Corneal Endothelial Damage and Toxic Anterior Segment
Syndrome
NOT FOR INTRACAMERAL USE OR INJECTION. MOXEZA will cause damage
to the corneal endothelium if introduced directly into the anterior
chamber of the eye.
Toxic Anterior Segment Syndrome (TASS) has been reported
following intraocular administration of moxifloxacin. TASS is
typically characterized by anterior chamber inflammatory reactions,
such as fibrin, cell or flare and corneal edema, but other events,
such as hypopyon, keratic precipitates or vitreous opacities may
also occur.
Hypersensitivity Reactions
In patients receiving systemically administered quinolones,
including moxifloxacin, serious and occasionally fatal
hypersensitivity (anaphylactic) reactions have been reported, some
following the first dose. Some reactions were accompanied by
cardiovascular collapse, loss of consciousness, angioedema
(including laryngeal, pharyngeal or facial edema), airway
obstruction, dyspnea, urticaria, and itching. If an allergic
reaction to moxifloxacin occurs, discontinue use of the drug.
Serious acute hypersensitivity reactions may require immediate
emergency treatment. Oxygen and airway management should be
administered as clinically indicated.
Growth of Resistant Organisms With Prolonged Use
As with other anti-infectives, prolonged use may result in
overgrowth of non-susceptible organisms, including fungi. If
superinfection occurs, discontinue use and institute alternative
therapy. Whenever clinical judgment dictates, the patient should be
examined with the aid of magnification, such as slit‑lamp
biomicroscopy, and, where appropriate, fluorescein staining.
Avoidance of Contact Lens Wear
Patients should be advised not to wear contact lenses if they
have signs or symptoms of bacterial conjunctivitis.
Information for Patients
Avoid Contamination of the Product
Advise patients not to touch the dropper tip to any surface to
avoid contaminating the contents.
Avoid Contact Lens Wear
Advise patients not to wear contact lenses if they have signs
and symptoms of bacterial conjunctivitis.
Hypersensitivity Reactions
Systemically administered quinolones, including moxifloxacin,
have been associated with hypersensitivity reactions, even
following a single dose. Advise patients to discontinue use
immediately and contact their physician at the first sign of a rash
or allergic reaction [see Warnings and Precautions].
Adverse Reactions
Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials
of a drug cannot be directly compared to the rates in the clinical
trials of another drug and may not reflect the rates observed in
practice.
The data described below reflect exposure to MOXEZA in 1263
patients, between 4 months and 92 years of age, with signs and
symptoms of bacterial conjunctivitis. The most frequently reported
adverse reactions were eye irritation, pyrexia and conjunctivitis,
reported in 1% to 2% of patients.
Please see Full Prescribing Information for IOPIDINE, MAXITROL,
and MOXEZA.
About Harrow Health
Harrow Health, Inc. (NASDAQ: HROW) is an ophthalmic-focused
healthcare company. The Company owns and operates ImprimisRx, one
of the nation’s leading ophthalmology-focused pharmaceutical
businesses, and Visionology, a direct-to-consumer eye care
subsidiary focused on chronic vision care. Harrow Health also holds
non-controlling equity positions in Eton Pharmaceuticals, Surface
Ophthalmics and Melt Pharmaceuticals, all of which started as
Harrow Health subsidiaries, and owns royalty rights in four
clinical‑stage drug candidates being developed by Surface
Ophthalmics and Melt Pharmaceuticals. For more information about
Harrow Health, please visit the Investors section of the corporate
website, harrowinc.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 Health’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 Health 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/20220624005018/en/
Investors Jamie Webb
Director of Communications and Investor Relations
jwebb@harrowinc.com 615-733-4737
Ordering Information Andrew
Thorrens VP/Head of Market Access athorrens@harrowinc.com
844-446-6979
Media Deb Holliday Holliday
Communications, Inc. deb@hollidaycommunications.net
412-877-4519
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