Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, has secured a five-year strategic supply and development agreement for TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL, the company announced on March 11, 2025. The agreement aims to ensure continuous availability of the preservative-free synthetic corticosteroid, which had previously been on the FDA's Drug Shortage List for over five years.
The company has simultaneously initiated development of a next-generation version of TRIESENCE®, with plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration before the end of 2027.
Strategic Manufacturing Partnership
The five-year agreement has been established with TRIESENCE®'s current contract manufacturing organization (CMO), which brings more than 15 years of experience with the product's manufacturing process. This partnership is expected to maintain quality consistency while ensuring reliable supply of the medication.
Mark L. Baum, Chairman and Chief Executive Officer of Harrow, emphasized the importance of this development: "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."
Clinical Applications and Market Position
TRIESENCE® is FDA-approved for two key ophthalmic applications: visualization during vitrectomy procedures and the treatment of ocular inflammatory conditions that have not responded adequately to topical corticosteroid therapy. As a preservative-free formulation of triamcinolone acetonide, the product addresses specific needs in ophthalmology where preservatives may be contraindicated.
The medication is currently available to healthcare providers through major pharmaceutical wholesale distributors, including Cencora, Cardinal Health, and McKesson, and is assigned J-Code 3300 for insurance reimbursement purposes.
Next-Generation Development
While securing the current supply chain, Harrow is simultaneously investing in enhancing the TRIESENCE® formulation. The company has not disclosed specific improvements planned for the next-generation version, but indicated it is "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," Baum stated.
Market Impact and Strategic Direction
This dual approach of securing current manufacturing while developing an enhanced formulation aligns with Harrow's broader business strategy of making ophthalmic pharmaceutical products more accessible and affordable. The company has been expanding its portfolio of prescription and non-prescription eye care products for the North American market.
Industry analysts note that stabilizing the supply of TRIESENCE® addresses a significant gap in the ophthalmic market, as the product's previous shortage had created challenges for retinal specialists and other ophthalmologists who rely on the medication for specific procedures and treatment protocols.
The development timeline, with an NDA submission targeted before the end of 2027, suggests Harrow is taking a methodical approach to the next-generation formulation, likely involving comprehensive clinical studies to support regulatory approval.
