Harrow Announces Market Access Wins for VEVYE®

Rhea-AI Summary

Harrow (HROW) has secured significant market access for VEVYE in the 2025 Medicare Part D Prescription Drug Program. Starting January 1, 2025, VEVYE will be included in formularies managed by Express Scripts, Cigna, Kaiser Permanente, and CVS Caremark, reaching over 25 million Medicare Part D beneficiaries. The drug has achieved coverage across 100% of U.S. Medicaid programs and 60% of commercial insurance coverage. This expansion particularly benefits older adults among the 67 million Medicare beneficiaries, including 54 million with Part D coverage, who are at increased risk for chronic dry eye disease (DED).

Positive

• Secured inclusion in major Medicare Part D formularies reaching over 25 million beneficiaries
• Achieved 100% coverage across U.S. Medicaid programs
• Obtained 60% commercial insurance coverage
• Access to large market potential with 54 million Medicare Part D beneficiaries

Negative

• None.

Insights

Market Research Analyst

The securing of major Medicare Part D formulary coverage for VEVYE represents a significant commercial milestone for Harrow. The combined reach of Express Scripts, Cigna, Kaiser Permanente and CVS Caremark provides access to over 25 million Medicare Part D beneficiaries, dramatically expanding VEVYE's market potential. With 100% Medicaid coverage and 60% commercial insurance coverage already in place, this Medicare expansion creates a robust foundation for revenue growth.

The timing is strategically important, targeting the 67 million Medicare beneficiaries in the U.S., of which 54 million have Part D coverage. The dry eye disease market among seniors represents a substantial opportunity, as the condition's prevalence increases with age. This expanded access positions VEVYE to capture a larger share of the competitive dry eye treatment market, potentially driving significant revenue growth starting in 2025.

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced its first major market access wins in the 2025 Medicare Part D Prescription Drug Program. Starting January 1, 2025, VEVYE will be included in key formularies managed by major plan sponsors such as Express Scripts, Cigna, Kaiser Permanente, and CVS Caremark. In the aggregate, these sponsors represent over 25 million Medicare Part D beneficiaries.

In addition to Medicare Part D, VEVYE has achieved broad coverage across other major insurance programs, including 100% of U.S. Medicaid programs and 60% of commercial insurance coverage. This breadth of coverage underscores Harrow’s commitment to ensuring that patients, regardless of their insurance type, have access to effective treatment for chronic dry eye disease (DED), a condition that affects millions of Americans and is especially impactful to older adults.

“Medicare access is essential for VEVYE’s continued successful progression as a preferred dry eye disease prescription choice, and we’re thrilled that we’ve secured these initial Medicare Part D formulary coverages – including with some of the largest 2025 Medicare Part D payers,” said Mark L. Baum, Chairman and Chief Executive Officer of Harrow. “For too long, Medicare beneficiaries have lacked an accessible, effective, and highly tolerable dry eye treatment. With 67 million Medicare beneficiaries in the U.S., including the 54 million with Medicare Part D prescription coverage, there is a substantial need for the unique clinical benefits that VEVYE offers. The prevalence of DED rises with age, and seniors face an increased risk for this chronic condition, affecting their comfort, vision, and overall quality of life. With this expanded access, we can better serve Medicare beneficiaries by improving their eye health, independence, and quality of life.”

About VEVYE

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 uniquely dispensed in a 10 microliter drop and is the first and only cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease (DED).

About Dry Eye Disease

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.¹

1 Source: Ophthalmology Innovation Source (OIS) Dry Eye Conference (March 2021)

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.

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 (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Quarterly Reports on Form 10-Q 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.

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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

Source: Harrow, Inc.

FAQ

When will VEVYE be available through Medicare Part D for Harrow (HROW)?

VEVYE will be available through Medicare Part D starting January 1, 2025.

What insurance coverage has VEVYE achieved for Harrow (HROW)?

VEVYE has achieved 100% coverage across U.S. Medicaid programs, 60% of commercial insurance coverage, and will be included in major Medicare Part D formularies.

Which major plan sponsors will include VEVYE in their 2025 Medicare Part D formularies?

Express Scripts, Cigna, Kaiser Permanente, and CVS Caremark will include VEVYE in their Medicare Part D formularies.