Harrow to enact a 5-year strategic supply and development agreement for triamcinolone acetonide injectable suspension

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This preservative-free synthetic corticosteroid is approved by the FDA for visualization during vitrectomy and the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids.

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Harrow is set to enact a five-year strategic supply and development (SSD) agreement for their triamcinolone acetonide injectable suspension (TRIESENCE) 40 mg/mL. This preservative-free synthetic corticosteroid is approved by the US Food and Drug Administration (FDA) for visualization during vitrectomy and the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids. TRIESENCE uses the J-Code 3300.

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 this suspension's manufacturing process.

Mark L. Baum, Chairman and Chief Executive Officer of Harrow, is quoted in the company’s press release on this news. He said, “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 5 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.

Harrow has also shared that the company is developing a next-generation version of its triamcinolone acetonide injectable suspension and plans to submit a new drug application (NDA) to the FDA before the end of 2027.