Harrow Executes Five-Year Strategic Supply and Development Agreement for TRIESENCE®

Rhea-AI Summary

Harrow (HROW) has executed a five-year strategic supply and development agreement for TRIESENCE®, a preservative-free synthetic corticosteroid approved by the FDA for visualization during vitrectomy and treatment of certain ocular inflammatory conditions. The agreement is with the current contract manufacturing organization that has over 15 years of experience with TRIESENCE manufacturing.

The company aims to ensure continuous supply of TRIESENCE, which had previously been on the FDA's Drug Shortage List for over five years. Additionally, Harrow has initiated development of a next-generation version of TRIESENCE, with plans to submit a new drug application (NDA) to the FDA by the end of 2027.

Positive

• Secured five-year manufacturing agreement ensuring stable TRIESENCE supply
• Development of next-generation TRIESENCE underway
• Partnership with experienced manufacturer (15+ years with TRIESENCE)
• Addressing previous supply shortage issues

Negative

• Next-generation product NDA submission not expected for ~4 years (end of 2027)

Company Developing Next-Generation TRIESENCE^®, Targeting NDA Submission to FDA by End of 2027

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, announced the execution of a five-year strategic supply and development (“SSD”) agreement for TRIESENCE^® (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative-free synthetic corticosteroid that is approved by the U.S. Food and Drug Administration (FDA) for visualization during vitrectomy and the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids. The SSD agreement is with the current contract manufacturing organization (CMO) producing TRIESENCE, ensuring continuity in quality and leveraging more than 15 years of experience with the TRIESENCE manufacturing process.

Harrow also announced that it has begun developing a next-generation version of TRIESENCE and plans to submit a new drug application (NDA) to the FDA before the end of 2027.

Mark L. Baum, Chairman and Chief Executive Officer of Harrow, stated, “When we acquired TRIESENCE, our first objective was to stabilize its supply and keep it off the FDA’s Drug Shortage List, where it had been for more than five years. By finalizing this strategic supply and development agreement, we’re ensuring the continued production of TRIESENCE under a trusted partnership with a world-class ophthalmic pharmaceutical manufacturer.

“At the same time, we’re developing an enhanced version of TRIESENCE, designed to deliver added value for physicians and their patients. These two initiatives – securing reliable supply and advancing a next-generation product – underscore our commitment to bolstering the TRIESENCE brand and meeting the evolving needs of the ophthalmic community.”

How to Order TRIESENCE
TRIESENCE (J-Code 3300) is available to healthcare providers directly through major pharmaceutical wholesale distributors, including Cencora, Cardinal Health, and McKesson.

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 (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.

About TRIESENCE^® (triamcinolone acetonide injectable suspension) 40 mg/mL:

HIGHLIGHTS OF TRIESENCE PRESCRIBING INFORMATION

INDICATIONS AND USAGE
TRIESENCE suspension is a synthetic corticosteroid indicated for:

• Treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
• Visualization during vitrectomy.

DOSAGE AND ADMINISTRATION

• Initial recommended dose for all indications except visualization: 4 mg (100 microliters of 40 mg/mL suspension) with subsequent dosage as needed over the course of treatment.
• Recommended dose for visualization: 1 to 4 mg (25 to 100 microliters of 40 mg/mL suspension) administered intravitreally.

DOSAGE FORMS AND STRENGTHS
Single use 1 mL vial containing 40 mg/mL of triamcinolone acetonide suspension.

CONTRAINDICATIONS

• Patients with systemic fungal infections.
• Hypersensitivity to triamcinolone or any component of this product.

WARNINGS AND PRECAUTIONS

• TRIESENCE suspension should not be administered intravenously.
• Ophthalmic effects: May include cataracts, infections, and glaucoma. Monitor intraocular pressure.
• Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome and hyperglycemia: Monitor patients for these conditions and taper doses gradually.
• Infections: Increased susceptibility to new infection and increased risk of exacerbation, dissemination, or reactivation of latent infection.
• Elevated blood pressure, salt and water retention, and hypokalemia: Monitor blood pressure and sodium, potassium serum levels.
• GI perforation: Increased risk in patients with certain GI disorders.
• Behavioral and mood disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis.
• Decreases in bone density: Monitor bone density in patients receiving long-term corticosteroid therapy.
• Live or live attenuated vaccines: Do not administer to patients receiving immunosuppressive doses of corticosteroids.
• Negative effects on growth and development: Monitor pediatric patients on long-term corticosteroid therapy.
• Use in pregnancy: Fetal harm can occur with first trimester use.
• Weight gain: May cause increased appetite.

DRUG INTERACTIONS

• Anticoagulant agents: May enhance or diminish anticoagulant effects. Monitor coagulation indices.
• Antidiabetic agents: May increase blood glucose concentrations. Dose adjustments of antidiabetic agents may be required.
• CYP 3A4 inducers and inhibitors: May respectively increase or decrease clearance of corticosteroids necessitating dose adjustment.
• Non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and salicylates: Increased risk of gastrointestinal side effects.

For complete product information about TRIESENCE, including important safety information, please visit: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3f045347-3e5e-4bbd-90f8-6c3100985ca5.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250311672040/en/

Investors:

Jamie Webb

Director of Communications and Investor Relations

Harrow, Inc.

jwebb@harrowinc.com

615-733-4737

Media:

Silvana Guerci-Lena

Powers and Company

silvana@powers-co.com

508-808-8993

Source: Harrow, Inc.

FAQ

What is the timeline for Harrow's next-generation TRIESENCE NDA submission to FDA?

Harrow plans to submit the new drug application (NDA) for next-generation TRIESENCE to the FDA before the end of 2027.

How long is Harrow's new strategic supply agreement for TRIESENCE?

The strategic supply and development agreement is for five years with the current contract manufacturing organization.

Where can healthcare providers purchase TRIESENCE (HROW)?

TRIESENCE (J-Code 3300) is available directly through major pharmaceutical wholesalers including Cencora, Cardinal Health, and McKesson.

What are the FDA-approved uses for TRIESENCE?

TRIESENCE is FDA-approved for visualization during vitrectomy and treating ocular inflammatory conditions unresponsive to topical corticosteroids.