Press Details

Agreements Support the Upcoming Launch of VEVYE^®

NASHVILLE, Tenn.--(BUSINESS WIRE)--Jan. 3, 2024-- Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced that it has partnered with three leading healthcare technology platforms to expand U.S. availability of VEVYE^® (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, twice-daily (BID) dosed, ophthalmic solution prescription drug based on a “water-free” semifluorinated alkane (SFA) eyedrop technology. VEVYE, uniquely dispensed in a 10 microliter drop, is the first and only cyclosporine-based product indicated for treating both signs and symptoms of dry eye disease (DED).

Harrow’s three market access partnerships for VEVYE include:

• PhilRx is an innovative patient access platform that provides end-to-end visibility into the entire prescription life cycle, starting when the eyecare professional (ECP) writes a VEVYE prescription electronically to PhilRx directly from their electronic health record (EHR). Using the PhilRx platform simplifies the prior authorization process (PA) for physicians by providing one-click submission of PAs, streamlining the insurance coverage process for patients, and increasing the chances of insurance reimbursement. PhilRx offers a variety of patient benefits, including best price, fast free shipping, text refill reminders, and best‑in-class customer service.
• Apollo Care is a comprehensive program designed to establish and manage copay program deployment, optimizing patient access and affordability of VEVYE.
• PARx Solutions is a web-based technology stack that helps prescribers – free of charge – overcome cumbersome, frustrating, and time-consuming challenges resulting from prior authorizations, thus ensuring that patients get the medication prescribed.

In commenting on the announcement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “Harrow was founded on a commitment to patient access. Our 360-degree approach to market access for VEVYE, including these new partnerships with PhilRx, Apollo Care, and PARx, is designed to ensure that all patients who can benefit from VEVYE and who are prescribed VEVYE – can get VEVYE.

“We believe VEVYE represents an important new prescription choice in the U.S. dry eye disease market, and we are excited to streamline the prior authorization process, guiding patients through their insurance coverage and ensuring competitive pricing – with minimum hassle. Harrow’s VEVYE market access program perfectly aligns with our commitment to providing physicians and their patients with innovative and affordable ophthalmic pharmaceutical products and the Harrow team eagerly anticipates the availability of VEVYE – next week.”

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.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240103973471/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

Source: Harrow, Inc.