VEVYE® Offers Rapid Onset with Clinically
and Statistically Meaningful Improvement
Beginning as Early as 15 Days1 with
Sustained Improvement over 56 Weeks2
VEVYE® Patients to Have Access to a 100%
Money-Back Guarantee Program3
Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical
company, today announced that VEVYE® (cyclosporine ophthalmic
solution) 0.1%, a patented, non‑preserved, twice-daily (BID) dosed
prescription drug based on a “water‑free” semifluorinated alkane
eyedrop technology, is now available in the U.S. – and
includes a 100% Money‑Back Guarantee program. VEVYE, uniquely
dispensed in a 10 microliter drop, is the first and only
cyclosporine‑based product indicated for treating both the signs
and symptoms of dry eye disease (DED).
In commenting on the announcement, Mark L. Baum, Chairman and
Chief Executive Officer of Harrow, said, “We are thrilled to
announce the availability of VEVYE for our customers and their
patients. VEVYE is powered by the unique combination of the
reliable and trusted active ingredient, cyclosporine, and a
water-free semifluorinated alkane delivery vehicle,
perfluorobutylpentane. We are excited to see VEVYE’s exceptional
clinical trial data come to life as U.S. dry eye disease patients
are now able to access and experience a highly tolerable product
that provides rapid onset of relief and sustained improvement of
both signs and symptoms of dry eye disease. Because of VEVYE’s
unique combination of both a potent 0.1% cyclosporine solute and a
pH- and osmolarity-free semifluorinated alkane, VEVYE is both
evolutionary and revolutionary, solving an unmet need for eyecare
professionals treating the tens of millions of American chronic dry
eye disease sufferers.”
Dry eye disease (DED) is a common condition that occurs when the
eyes do not produce enough tears or when the tears evaporate too
quickly, and it is often associated with chronic inflammation.
Untreated DED can lead to discomfort such as stinging, burning or
blurry vision, and chronic DED can interfere with daily activities
like reading and using a computer. More serious consequences
include increased risk of eye infections and damage to the surface
of the eye, which can potentially result in serious vision problems
and even loss of sight. Causes of dry eye are varied and can
include aging, certain medications, medical conditions, or
environmental factors such as increased screen time and exposure to
pollutants, all of which are contributing to a forecast of
continued significant increase in DED. According to a 2020 report
from Market Scope, DED affects more than 38 million Americans. In
addition, 92% of this patient population remains un- or
under-treated due to limited efficacy and poor tolerability of
existing prescription and non-prescription choices.4
Comments from Ophthalmic KOLs (Key Opinion Leaders) on
VEVYE
“As an ophthalmologist and ocular surface specialist, I have
served as principal investigator in over 120 clinical trials, half
of which targeted dry eye disease. As participants in VEVYE’s
clinical trials, our team found the results to be compelling. The
data in both consecutive registration trials demonstrated
impressive efficacy, safety and tolerability, with rapid clinical
onset beginning as early as 15 days and continuous improvement for
more than one year. VEVYE represents not just an innovative
treatment; it exemplifies the penultimate synthesis of outstanding
vehicle with cyclosporine, the active pharmaceutical ingredient,
boasting a superlative decades long track record. Tolerability and
risk profile are impressive compared with most existing dry eye
products, portending improved patient compliance. Indicated for
both signs and symptoms, VEVYE should expand the market and
fundamentally enhance dry eye disease treatment algorithms.”
— John D. Sheppard, M.D., M.M.Sc., F.A.C.S., corneal external
disease fellowship trained ophthalmologist and founding senior
partner of Virginia Eye Consultants, Norfolk, VA
“When a patient presents with dry eye disease, it is often
difficult to initially classify them into a specific category, such
as aqueous deficient, evaporative, or a combination of the two. In
addition, they often present with inflammation leading to many of
their dry eye symptoms. That is why VEVYE, with cyclosporine in a
semifluorinated alkane solution, provides us with a valuable tool
to address the signs and symptoms of dry eye holistically,
regardless of etiology.”
— Paul Karpecki, OD, FAAO, Director, cornea and external
disease, Kentucky Eye Institute, and associate professor, Kentucky
College of Optometry UPIKE, Lexington, KY
“VEVYE continues the trend of advanced cyclosporine formulations
coming to market that are designed to address key issues of onset
of action and tolerability. As the first cyclosporine with an FDA
indication for signs and symptoms and the first anti‑inflammatory
drop in the new category of anhydrous or water-free formulations,
VEVYE is well-positioned to add unique clinical value to the
expanding market of excellent anti-inflammatory dry eye disease
therapeutics.”
— Richard Adler, M.D., corneal, refractive, and external disease
fellowship trained ophthalmologist at Belcara Health, Baltimore,
MD
“As a glaucoma specialist who treats advanced glaucoma, I’ve
been looking forward to the availability of VEVYE, a two-hit
treatment for ocular surface disease targeting longstanding
inflammation and corneal damage in as quickly as 15 days. A large
portion of patients with glaucoma also have dry eye disease with
extensive cornea damage due to the use of topical glaucoma
medications. I look forward to the rapid relief my patients will
receive from the addition of preservative-free VEVYE.”
— Courtney Bovee, M.D., cataract and glaucoma surgeon at The
Macula Center and Blue Ocean Clinical Research Center, Tampa Bay,
FL.
“Clinicians have been waiting a long time for a dry eye
treatment that combines the effectiveness of cyclosporine with the
tolerability of this unique semifluorinated alkane vehicle. In
VEVYE, the vehicle makes all the difference, allowing the product
to spread evenly over the ocular surface with longer residual time
and increased penetration of cyclosporine.”
— John A. Hovanesian, M.D., cataract, corneal and laser eye
surgeon and a principal at Harvard Eye Associates, Laguna Hills,
CA
“As an eyecare professional, I recognize the critical need for a
dry eye product that not only acts swiftly and effectively, but
also is comfortable enough to encourage continued patient use. A
dry eye product that is well tolerated, has no or mild discomfort
or adverse effects, and can easily be incorporated into a patient’s
daily routine is key to successful long-term management of dry eye
syndrome. VEVYE’s twice‑daily dosing should also contribute to
patient compliance, thus promoting overall effectiveness of the
treatment. I am excited to see the positive changes that VEVYE can
bring to patients suffering from dry eye disease.”
— William B. Trattler, M.D., cataract, refractive, and corneal
surgeon and Director of Cornea at the Center for Excellence in Eye
Care, Miami, FL
How to Order VEVYE
Eyecare professionals can send prescriptions for VEVYE, using
their electronic medical record (EMR), directly to Harrow’s
dedicated pharmacy partner, PhilRx. Prescriptions can also be sent
to any retail pharmacy. VEVYE is fully stocked in the wholesale
distribution channel and can be shipped to any retail pharmacy,
generally within 24 hours of order placement.
In addition, VEVYE is available directly through the wholesale
distributors, including McKesson, Cardinal and Cencora (f/k/a
AmerisourceBergen).
Interested patients should ask their trusted eyecare
professional whether VEVYE is right for them.
VEVYE Patient Access Program
Harrow has established a VEVYE Patient Access program, under
which eligible patients may receive their first VEVYE prescription
for as low as $0.5
Harrow also offers a 100% money-back guarantee for eligible
patients.3
More information on Harrow’s Patient Access program is available
at getvevye.com.
For more information about VEVYE, please visit vevye.com.
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 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, 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 VEVYE® (cyclosporine ophthalmic solution) 0.1%
VEVYE (cyclosporine ophthalmic solution) 0.1%, non-preserved,
for topical ophthalmic use. Approved by the U.S. Food and Drug
Administration (FDA) in June 2023, VEVYE combines a semifluorinated
alkane eyedrop technology (perfluorobutylpentane) with cyclosporine
0.1% in solution. VEVYE is indicated to treat both the signs and
symptoms of DED. Clinical trials for VEVYE have demonstrated that
it not only increases tear production, but it also has been shown
to improve the cornea surface as evidenced by total corneal
fluorescein staining (tCFS). Clinical trials also show that VEVYE’s
clinical benefits begin as early as 15 days and show sustained
improvement over 12 months – all while maintaining an excellent
patient tolerability and low adverse event profile.
INDICATIONS AND USAGE
VEVYE is indicated for the treatment of the signs and symptoms
of dry eye disease.
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Potential for Eye Injury and Contamination. To avoid the
potential for eye injury and/or contamination, patients should not
touch the bottle tip to the eye or other surfaces.
Use with Contact Lenses. VEVYE should not be administered while
wearing contact lenses. If contact lenses are worn, they should be
removed prior to administration of the solution. Lenses may be
reinserted 15 minutes following administration of VEVYE ophthalmic
solution.
ADVERSE REACTIONS
Clinical Trials Experience. 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 rates in the clinical trials of another drug and may
not reflect the rates observed in practice. In clinical trials with
738 subjects receiving at least 1 dose of VEVYE, the most common
adverse reactions were instillation site reactions (8%) and
temporary decreases in visual acuity (3%).
USE IN SPECIAL POPULATIONS
Pregnancy. There are no adequate and well-controlled studies of
VEVYE administration in pregnant women to inform a drug-associated
risk.
Lactation. Caution should be exercised when VEVYE is
administered to a nursing woman.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
For additional information about VEVYE, please see the Full
Prescribing Information.
1 Pooled study data. 2 An open-label, single-arm, extension
study. 3 This offer is available on one fill only, and is valid
only for eligible patients paying cash who do not have commercial
or government insurance. This offer is not valid for patients with
government insurance, including, but not limited to, Medicaid or
Medicare. Contact Harrow at 833-442-7769 for information on how to
apply for your money-back guarantee. Additional terms and
conditions apply. This offer is available through any participating
retail pharmacy. 4 Source: Ophthalmology Innovation Source (OIS)
Dry Eye Conference (March 2021) 5 By participating in the program,
patients acknowledge that they currently meet the eligibility
criteria. This program is only available for eligible commercially
insured patients who are dispensed VEVYE by PhilRx or another
participating pharmacy. This offer is not valid for patients with
government insurance, including, but not limited to, Medicaid or
Medicare. A patient’s out‑of‑pocket cost may be greater based on
patient’s plan benefit design. Additional terms and conditions
apply. All patients, including uninsured, commercially insured, and
government-insured, may be eligible for manufacturer cash discount
pricing subject to program terms and conditions for opt out.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240111803510/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
Harrow (NASDAQ:HROW)
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