Form 8-K

8-K — HARROW, INC.

Accession: 0001493152-26-036256

Filed: 2026-08-06

Period: 2026-08-03

CIK: 0001360214

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Entry into a Material Definitive Agreement

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date

of Report (Date of earliest event reported): August 3, 2026

HARROW,

INC.

(Exact

name of registrant as specified in its charter)

Delaware

001-35814

45-0567010

(State

or other jurisdiction

incorporation)

(Commission

File

Number)

(IRS

Employer

Identification

No.)

Burton Hills Blvd., Suite 200

Nashville,

Tennessee

37215

(Address

of principal executive offices)

(Zip

Code)

Registrant’s

telephone number, including area code: (615) 733-4730

Not

Applicable

(Former

Name or Former Address, if Changed Since Last Report)

Securities

registered pursuant to Section 12(b) of the Act:

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which registered

Common

Stock, $0.001 par value per share

HROW

The

Nasdaq Stock Market LLC

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under

any of the following provisions:

☐

Written

communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate

by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2

of the Securities Act of 1934: Emerging growth company ☐

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item

1.01. Entry into a Material Definitive Agreement.

August 3, 2026, Harrow, Inc. (the “Company”) entered into an Asset Purchase Agreement (the “Purchase Agreement”)

with Viatris Inc. (“Viatris”), pursuant to which the Company agreed to acquire the global rights to TYRVAYA® (varenicline

solution) nasal spray 0.03 mg (“TYRVAYA”), a cholinergic agonist indicated for the treatment of the signs and symptoms of

dry eye disease (the “Acquisition”).

Under

the terms of the Purchase Agreement, the Company will acquire the assets primarily related to TYRVAYA, including the related new drug

application and other regulatory approvals, intellectual property, developed technology, inventory, and certain related contracts, and

will assume certain specified liabilities relating to the acquired assets.

consideration for the Acquisition, the Company will pay Viatris thirty million dollars ($30,000,000) in cash at the closing of the Acquisition

(the “Closing”) and has agreed to pay up to an additional seventy million dollars ($70,000,000) in contingent milestone payments,

payable if specified annual net sales thresholds for TYRVAYA are achieved in certain calendar years following the Closing. The Company

expects to fund the cash payment due at Closing with cash on hand. The purchase price is subject to a customary post-Closing adjustment

based on the net working capital transferred at the Closing.

The

Purchase Agreement contains customary representations, warranties, and covenants of the Company and Viatris, including covenants

regarding the operation of the TYRVAYA business prior to the Closing, employee matters, and a customary non-competition covenant

applicable to Viatris. The Purchase Agreement also contains customary indemnification provisions and customary termination rights.

The Closing is subject to the satisfaction or waiver of customary closing conditions. The Company expects the Closing to occur in

the second half of 2026, although there can be no assurance that the Acquisition will be completed on the anticipated timeline or at

all. In connection with the Closing, the Company and Viatris will also enter into certain ancillary agreements, including a

transition services agreement.

The

foregoing description of the Purchase Agreement is a summary only, does not purport to be complete, and is qualified in its entirety

by reference to the full text of the Purchase Agreement. The Company intends to file the Purchase Agreement as an exhibit to its Quarterly

Report on Form 10-Q for the quarterly period ending September 30, 2026.

The

representations, warranties, and covenants contained in the Purchase Agreement were made only for purposes of that agreement and as of

specific dates; were solely for the benefit of the parties to the Purchase Agreement; may be subject to limitations, qualifications,

and exceptions agreed upon by the parties, including being qualified by confidential disclosures made for the purpose of allocating contractual

risk between the parties rather than establishing matters as facts; and may be subject to standards of materiality applicable to the

contracting parties that differ from those generally applicable to investors. Investors should not rely on the representations, warranties,

and covenants, or any description thereof, as characterizations of the actual state of facts or condition of the Company, Viatris, or

any of their respective subsidiaries or affiliates.

Item

7.01. Regulation FD Disclosure.

August 6, 2026, the Company issued a press release announcing the execution of the Purchase Agreement. A copy of the press release is

furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The

information contained in this Item 7.01, including Exhibit 99.1 furnished herewith, shall not be deemed “filed” for purposes

of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities

of that Section, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the

Exchange Act, except as expressly set forth by specific reference in such a filing.

Forward-Looking

Statements

This

Current Report on Form 8-K contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation

Reform Act of 1995, including statements regarding the expected timing and completion of the Acquisition, the satisfaction of closing

conditions, the anticipated funding of the purchase price, and the potential achievement of contingent milestone payments. Any statements

that are not historical facts may be considered forward-looking statements. Forward-looking statements are based on management’s

current expectations and are subject to risks and uncertainties that may cause actual results to differ materially and adversely from

those expressed or implied, including risks that the Acquisition may not be completed on the anticipated timeline or at all, that the

anticipated benefits of the Acquisition may not be realized, and the other risks described in the Company’s filings with the Securities

and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025 and its subsequent Quarterly Reports

on Form 10-Q. 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, the Company undertakes no obligation to update any forward-looking statements.

Item

9.01. Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit

No.

Description

99.1

Press Release, dated August 6, 2026

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned hereunto duly authorized.

HARROW,

INC.

Dated:

August 6, 2026

By:

/s/

Andrew R. Boll

Andrew

R. Boll

President

& Chief Financial Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

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.”

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

(April 2022)

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®

Page 2

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

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®

Page 3

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®

Page 4

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®

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

mbiega@harrowinc.com

617-913-8890

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Title of a 12(b) registered security.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Name of the Exchange on which a security is registered.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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