Harrow Enters into 340B Prime Vendor Program Contract with Apexus™ for IHEEZO® and Other Key Harrow Products

Rhea-AI Summary

Harrow (Nasdaq: HROW) has entered into an agreement with Apexus to offer its products, including IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3%, through the 340B Prime Vendor Program starting July 1, 2024. The 340B PVP, managed by Apexus, aims to enhance purchasing power for U.S. hospitals and ensure access to discounted medications. Additional Harrow products included are VIGAMOX®, a bacterial conjunctivitis treatment, and ILEVRO®, an NSAID for ocular pain and inflammation. This agreement aims to open access to Harrow's products for the U.S. hospital market, significantly impacting the 44% of hospitals participating in the program.

Positive

• Harrow's products will be available through the 340B Prime Vendor Program starting July 1, 2024.
• The inclusion of IHEEZO® and other products aims to enhance accessibility and affordability for U.S. hospitals, benefiting vulnerable populations.
• Approximately 44% of U.S. hospitals participate in the 340B Prime Vendor Program, potentially increasing Harrow's market reach.

Negative

• The impact of the agreement on Harrow's overall revenue and profitability is not disclosed.

Insights

Market Research Analyst

Harrow's entry into the 340B Prime Vendor Program with Apexus is a strategic move that broadens its market reach, particularly in the U.S. hospital sector. The 340B Program is designed to provide discounted medications to eligible health care organizations, which enhances the purchasing power of these institutions. By making IHEEZO and other key products available through this program, Harrow is aligning itself with a larger segment of the healthcare market, potentially increasing its customer base and sales volume.

From a market dynamics perspective, this agreement positions Harrow to better serve hospitals, especially those dealing with a high volume of eye-related emergency cases. Given the 2.4 million annual emergency room visits related to eye problems in U.S. hospitals, the demand for effective ocular anesthesia like IHEEZO is substantial. This expanded access not only caters to immediate medical needs but may also foster long-term relationships with healthcare providers, driving sustained revenue growth.

For retail investors, this could translate into a more stable revenue stream and potentially improved financial performance for Harrow. The company's commitment to affordability and access aligns with current healthcare trends, emphasizing value-based care and cost containment. Over time, this might also improve Harrow's market position and brand reputation.

Financial Analyst

Harrow's agreement to join the 340B Prime Vendor Program with Apexus is likely to have both immediate and long-term financial implications. The program will enable eligible hospitals to purchase Harrow's products at discounted prices, potentially driving higher sales volumes. While the discount aspect might initially suggest a lower per-unit revenue, the overall increase in sales volume can compensate for this, leading to potentially greater total revenue.

From a financial metrics standpoint, the expanded market reach could enhance Harrow's revenue streams and improve its market share in the ocular pharmaceutical segment. Over the long term, consistent sales through the 340B Program can contribute to stable revenue streams, reducing the company’s dependency on other more volatile revenue sources. Additionally, this agreement could lead to better inventory management and economies of scale, potentially improving Harrow's gross margins over time.

However, it is essential to monitor the financial impact closely. The discount pricing could pressure margins in the short term and the company will need to ensure that increased sales volumes sufficiently offset these discounts. Investors should keep an eye on upcoming quarterly results to see how this agreement impacts Harrow's profit margins and overall financial health.

Medical Research Analyst

From a medical and clinical perspective, Harrow's products like IHEEZO, VIGAMOX and ILEVRO are significant in addressing common ocular conditions. IHEEZO’s application in the emergency room setting, where eye anesthesia is frequently required, highlights a critical use case. The product's efficacy and safety profile make it a reliable option for healthcare providers, potentially improving patient outcomes during acute eye conditions.

The inclusion of VIGAMOX and ILEVRO in the 340B Program further strengthens Harrow’s portfolio available to hospitals. VIGAMOX, used for bacterial conjunctivitis and ILEVRO, an NSAID for pain and inflammation, address common and frequent ophthalmic conditions. By ensuring these medications are accessible under the 340B Program, Harrow is contributing to better clinical management of eye diseases, particularly in underserved populations that benefit from the program.

This strategic alignment with the 340B Program also underscores Harrow’s commitment to making essential medications affordable and accessible. For investors, this alignment not only promises better sales performance but also enhances Harrow's reputation as a company dedicated to public health and patient care.

Contract Enhances Purchasing Power for 340B Prime Vendor Program (PVP) Participants; Aligns with Harrow’s Mission to Make Its Products Accessible and Affordable

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced that as of July 1, 2024, it has entered into an agreement with Apexus to make IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3% and other Harrow products available through its 340B Prime Vendor Program. IHEEZO, indicated for ocular anesthesia, is a low-viscosity topical ocular anesthetic gel with reliable efficacy, a proven safety profile, and simple administration. Other Harrow products available through the program include VIGAMOX®, a topical eye drop for bacterial conjunctivitis, and ILEVRO®, an ocular nonsteroidal anti-inflammatory (NSAID) topical eye drop for pain and inflammation.

In commenting on the agreement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “We believe the value this agreement provides to eligible participants will open access to IHEEZO for the U.S. hospital market. According to the U.S. Centers for Disease Control and Prevention, approximately 2.4 million annual emergency room visits in U.S. hospitals are due to eye-related problems, including the removal of foreign bodies and other acute conditions, many of which require anesthetizing the eye. Consistent with our commitment to ensure access and affordability to our products, with around 44% of U.S. hospitals participating in the Apexus 340B Prime Vendor Program, we are thrilled about the potential benefits we see from our new relationship, especially for vulnerable populations.”

The 340B Prime Vendor Program, managed by Apexus, is a contract awarded by the Health Resources and Services Administration (“HRSA”), an agency of the U.S. Department of Health and Human Services, which is responsible for administering the 340B Drug Pricing Program. As the Prime Vendor, Apexus contracts with manufacturers and distributors to help ensure access to discounted medications, provides 340B education to all stakeholders, and helps support program integrity through technical assistance.

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. 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 IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3%

• IHEEZO is a sterile, single-patient‑use, physician‑administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia.
• IHEEZO was approved by the FDA on September 26, 2022.
• Clinical trials of IHEEZO demonstrated that patients treated with IHEEZO did not require any supplemental treatment to complete the intended surgical procedure.
• IHEEZO represents the first approved use in the U.S. ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years.
• IHEEZO is protected by an Orange Book-listed patent that is valid until 2038.

INDICATIONS AND USAGE

IHEEZO™ is indicated for ocular surface anesthesia.

CONTRAINDICATIONS

IHEEZO™ is contraindicated in patients with a history of hypersensitivity to any component of this preparation.

WARNINGS AND PRECAUTIONS

IHEEZO™ should not be injected or intraocularly administered. Patients should not touch the eye for at least 10 to 20 minutes after using an anesthetic as accidental injuries can occur due to insensitivity of the eye. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. Do not touch the dropper tip to any surface as this may contaminate the gel. IHEEZO™ is indicated for administration under the direct supervision of a healthcare provider. IHEEZO™ is not intended for patient self-administration.

ADVERSE REACTIONS

The most common adverse reaction is mydriasis (approximately 25%).

For complete product information about IHEEZO®, including important safety information, please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea3b2d2c-8b33-d199-e053-2995a90a699c.

About VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%:

INDICATIONS AND USAGE

VIGAMOX® is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, and Chlamydia trachomatis.

*Efficacy for this organism was studied in fewer than 10 infections.

IMPORTANT SAFETY INFORMATION

Contraindications

VIGAMOX® is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.

Warnings and Precautions

• Hypersensitivity Reactions – Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin.
• Prolonged Use – May result in overgrowth of non-susceptible organisms, including fungi.
• Avoid Contact Lens Wear – Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

Adverse Reactions

The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1%-6% of patients.

Nonocular adverse events reported at a rate of 1%-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.

For complete product information about VIGAMOX®, including important safety information, please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ad783689-2b59-448c-b0d6-e8b70cf8b062.

About ILEVRO® (nepafenac ophthalmic suspension) 0.3%

ILEVRO® (nepafenac ophthalmic suspension) 0.3%, a nonsteroidal, anti-inflammatory eye drop indicated for pain and inflammation associated with cataract surgery.

INDICATIONS AND USAGE

ILEVRO® 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery.

CONTRAINDICATIONS

ILEVRO® 0.3% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other nonsteroidal anti-inflammatory drugs (NSAIDs).

WARNINGS AND PRECAUTIONS

Increased Bleeding Time. With some NSAIDs including ILEVRO® 0.3%, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery. It is recommended that ILEVRO® 0.3% be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

Delayed Healing. Topical NSAIDs including ILEVRO® 0.3%, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

Corneal Effects. Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs including ILEVRO® 0.3% and should be closely monitored for corneal health.

Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events, which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk and severity of corneal adverse events.

Contact Lens Wear. ILEVRO® 0.3% should not be administered while using contact lenses.

ADVERSE REACTIONS

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Serious and Otherwise Important Adverse Reactions. The following adverse reactions are discussed in greater detail in other sections of labeling: (1) Increased Bleeding Time, (2) Delayed Healing and (3) Corneal Effects.

Ocular Adverse Reactions. The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These reactions occurred in approximately 5 to 10% of patients. Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment. Some of these reactions may be the consequence of the cataract surgical procedure.

Non-Ocular Adverse Reactions. Non-ocular adverse reactions reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting, and sinusitis.

For complete product information about ILEVRO®, including important safety information, please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10f411d3-a81e-074a-e063-6294a90ab547.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240709623740/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.

FAQ

What is the significance of Harrow's agreement with Apexus for IHEEZO?

Harrow's agreement with Apexus aims to make IHEEZO® more accessible and affordable for U.S. hospitals through the 340B Prime Vendor Program, enhancing the purchasing power of participating hospitals.

When will Harrow's products be available through the 340B Prime Vendor Program?

Harrow's products, including IHEEZO®, will be available through the 340B Prime Vendor Program starting July 1, 2024.

What products from Harrow will be included in the 340B Prime Vendor Program?

Products included are IHEEZO® for ocular anesthesia, VIGAMOX® for bacterial conjunctivitis, and ILEVRO® for ocular pain and inflammation.

How many U.S. hospitals participate in the 340B Prime Vendor Program?

Approximately 44% of U.S. hospitals participate in the 340B Prime Vendor Program.

What is the expected impact of the 340B Prime Vendor Program on Harrow's market reach?

By joining the 340B Prime Vendor Program, Harrow expects to significantly extend its market reach to the 44% of U.S. hospitals participating in the program.