Harrow斥1億美元收購TYRVAYA全球權利 擴充乾眼症產品線

EX-99.1
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Exhibit
99.1

 

 

 

Harrow
Acquires Global Rights to TYRVAYA®, 

the
First and Only FDA-Approved Nasal Spray for Dry Eye Disease

 

NASHVILLE,
Tenn., August 6, 2026 – Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America,
today announced that it has entered into a definitive agreement to acquire TYRVAYA® (varenicline solution) nasal spray 0.03 mg from
Viatris Inc., a global healthcare company. TYRVAYA is a cholinergic agonist indicated for the treatment of the signs and symptoms of
dry eye disease (DED) and is currently approved in the U.S., China, and Taiwan, with marketing authorization applications pending in
other countries.

 

This
acquisition expands Harrow’s dry eye portfolio, complementing the Company’s flagship VEVYE franchise by addressing dry eye
disease with a different underlying mechanism of action. Together, VEVYE and TYRVAYA enable Harrow to provide physicians with a broader
range of differentiated treatment options while addressing the diverse needs of patients with dry eye disease. Because TYRVAYA is delivered
as a nasal spray rather than an eye drop, it avoids ocular instillation-site reactions entirely; its prescribing information includes
no contraindications and no warnings or precautions, and its most common adverse reaction, sneezing, is transient. Drop-free DED management
is a meaningful differentiator for patients who struggle with or cannot tolerate topical drops, including those who experience burning,
stinging, or other ocular adverse reactions associated with eye drops. The acquisition also leverages Harrow’s sales, marketing,
market access, medical affairs, and reimbursement infrastructure and is expected to further strengthen the Company through the addition
of select talent from Viatris.

 

Under
the terms of the agreement, Harrow will pay $30 million in cash at closing and up to $70 million in contingent milestone payments tied
to TYRVAYA’s net sales, for a potential total consideration of up to $100 million. Harrow expects to fund the upfront cash payment
using cash on hand. The transaction is expected to close in the second half of 2026, subject to customary closing conditions.

 

“This
acquisition is about Harrow’s commitment to offer the most comprehensive set of tools to help U.S. ophthalmologists and optometrists
manage their patients’ dry eye disease. By adding TYRVAYA to our portfolio, we now have a highly effective and differentiated product
that may be prescribed separately from VEVYE or in addition to VEVYE,” said Mark L. Baum, Chief Executive Officer of Harrow. “While
VEVYE remains the cornerstone of our dry eye franchise, TYRVAYA strengthens our foundation by expanding the number of patients and physicians
we can serve through a complementary mechanism of action: VEVYE addresses the inflammatory component of dry eye disease, and TYRVAYA
stimulates the body’s natural basal tear production – literally within minutes of the first dosei. Also,
as the first and only FDA-approved nasal spray for dry eye disease, TYRVAYA offers the 45+ millionii U.S. contact lens wearers
a drop-free treatment option because it is the only prescription therapy that does not require lens removal before administration. We
believe Harrow is now uniquely positioned to accelerate growth across our dry eye franchise by providing physicians with greater flexibility
to individualize treatment for their patients.”

 

 

i
ONSET-1 and ONSET-2 pivotal clinical trials of TYRVAYA (varenicline solution) nasal spray. Published in Cornea (October 2022) and Ophthalmology
(April 2022)

ii
Centers for Disease Control and Prevention. “About Contact Lenses.” Healthy Contact Lens Wear and Care. Published May 8,
2024

 

  

 Harrow to Acquire TYRVAYA® from Viatris, Expanding Category-Leading Dry Eye Franchise Anchored by VEVYE®
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August 06, 2026

 

 

“This
transaction is another example of the disciplined approach to capital allocation and business development that has become a hallmark
of Harrow’s growth strategy,” said Andrew Boll, President and Chief Financial Officer of Harrow. “This transaction
aligns with what we believe is an attractive investment, providing a long-term stream of strategic value creation, with the primary purchase
payment from cash on hand and any additional payments made only if net revenue milestones are achieved. Moreover, TYRVAYA is ‘plug
and play’ with our existing cost structure, and given the existing stream of revenue TYRVAYA produces, is expected to be financially
accretive shortly after the transaction closes.”

 

Building
a Broad and Diverse U.S. Dry Eye Franchise

 

Dry
eye disease is a complex, multifactorial condition that often requires different therapeutic approaches depending on (i) the underlying
cause of the disease and (ii) the individual patient’s needs. Harrow’s unique approach to serving the dry eye community is
centered on VEVYE and TYRVAYA, as well as FreshKote® Preservative Free, an OTC lubricant eye drop for the temporary relief of dry
eye symptoms, and FLAREX®, a corticosteroid that treats ocular surface inflammation, well suited for managing flares – and
is supported by the Harrow commercial team. Collectively, Harrow has created one of the industry’s most comprehensive branded dry
eye franchises, with multiple complementary therapies that address distinct mechanisms of dry eye disease and all phases of the patient’s
treatment continuum.

 

Harrow’s
Chief Commercial Officer, Patrick Sullivan, added, “There are literally thousands of physicians writing TYRVAYA today, and the
brand comes to us with real promotional awareness already built – that is a rare thing to be able to acquire. VEVYE will remain
positioned as Harrow’s first-line anchor product for chronic dry eye disease, with TYRVAYA promoted and fully supported as a unique,
fast-acting, safe, and clinically proven prescription tool in physicians’ armamentaria for patients who struggle with, or resist
drops or contact lens wear. Our team can now introduce VEVYE to the established base of TYRVAYA prescribers and TYRVAYA to the physicians
who already trust VEVYE, adding unique writers to both franchises. Every physician interaction now carries two branded prescription options
instead of one, which we expect to raise the productivity of our commercial organization and strengthen the growth trajectory of both
VEVYE and TYRVAYA, as well as our entire ocular surface franchise.”

 

VEVYE®
(cyclosporine ophthalmic solution) 0.1%

 

Indications
and Usage

 

VEVYE®
(cyclosporine ophthalmic solution) 0.1% is indicated for the treatment of the signs and symptoms of dry eye disease.

 

Important
Safety Information

 

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 the administration of VEVYE®.

 

ADVERSE
REACTIONS

 

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%).

 

TYRVAYA®
(varenicline solution) nasal spray 0.03 mg

 

INDICATIONS
AND USAGE

 

TYRVAYA
(varenicline solution) nasal spray is a cholinergic agonist indicated for the treatment of the signs and symptoms of dry eye disease

 

  

 Harrow to Acquire TYRVAYA® from Viatris, Expanding Category-Leading Dry Eye Franchise Anchored by VEVYE®
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August 06, 2026

 

 

ADVERSE
REACTIONS

 

The
most common adverse reaction reported in 82% of patients was sneezing. Events that were reported in 5-16% of patients were cough, throat
irritation, and instillation-site (nose) irritation.

 

FLAREX®
(fluorometholone acetate ophthalmic suspension) 0.1%

 

Indications
and Usage

 

FLAREX®
(fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid-responsive inflammatory conditions
of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

 

Important
Safety Information

 

CONTRAINDICATIONS

 

Contraindicated
in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva; mycobacterial
infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be
masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation.

 

WARNINGS
AND PRECAUTIONS

 

Topical
Ophthalmic Use: Not for injection.

 

Intraocular
Pressure Increase: Prolonged use may result in glaucoma, damage to the optic nerve, and defects in visual acuity and visual field. It
is advisable that the intraocular pressure be checked frequently.

 

Cataracts:
Use of corticosteroids may result in cataract formation.

 

Delayed
Healing: Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera,
perforation has been known to occur with chronic use of topical steroids.

 

Viral
Infections: Use in the treatment of herpes simplex infection requires great caution.

 

Bacterial
Infections: Use of corticosteroids may suppress the host response and thus aid in the establishment of secondary ocular infections. Acute
purulent infections of the eye may be masked or exacerbated by the presence of steroid medication.

 

Fungal
Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application.
Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.

 

  

 Harrow to Acquire TYRVAYA® from Viatris, Expanding Category-Leading Dry Eye Franchise Anchored by VEVYE®
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August 06, 2026

 

 

Contamination:
Do not touch dropper tip to any surface as this may contaminate the suspension.

 

Contact
Lens Wear: Contact lenses should be removed during instillation of FLAREX but may be reinserted 15 minutes after instillation.

 

Temporarily
Blurred Vision: Vision may be temporarily blurred following dosing with FLAREX. Care should be exercised in operating machinery or driving
a motor vehicle.

 

ADVERSE
REACTIONS

 

Glaucoma
with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host
response, and perforation of the globe may occur. Post marketing 

 

Experience:
The following reaction has been identified during post marketing use of FLAREX in clinical practice. Because reactions are reported voluntarily
from a population of unknown size, estimates of frequency cannot be made. The reaction, which has been chosen for inclusion due to either
its seriousness, frequency of reporting, possible causal connection to FLAREX, or a combination of these factors, includes dysgeusia.
The following rare adverse reactions have been reported: Cushing’s syndrome and adrenal suppression may occur after very frequent
use of topical ophthalmic corticosteroids, particularly in very young children.

 

FRESHKOTE®

 

FRESHKOTE®
Preservative Free (PF) is a lubricant eye drop that temporarily relieves burning, itching and other dry eye symptoms.

 

About
Harrow

 

Harrow,
Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio
of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related
macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina.
Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance
and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn.

 

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,
including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing
facility in New Jersey; 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 (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. 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.

 

Contacts:

Mike
Biega

Vice
President of Investor Relations and Communications

[email protected]

617-913-8890

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