Harrow has finalized a 5-year strategic supply and development (SSD) agreement to ensure the continued production of Triesence® (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative-free synthetic corticosteroid approved by the FDA for vitrectomy visualization and the treatment of ocular inflammatory conditions unresponsive to topical corticosteroids.
The agreement is established with the current contract manufacturing organization (CMO) responsible for producing Triesence. This collaboration is expected to maintain a reliable supply of the drug, which had remained on the FDA’s Drug Shortage List for over five years before Harrow acquired the product.
Mark L. Baum, Chairman and CEO of Harrow, emphasized the significance of this agreement in a company news release:
“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.”
In addition to securing the long-term availability of Triesence, Harrow has announced plans to develop a next-generation formulation of the drug. The company intends to submit a New Drug Application (NDA) to the FDA before the end of 2027, signaling its commitment to advancing ophthalmic treatment options.
This 5-year strategic agreement not only secures the availability of Triesence but also sets the stage for innovation in ocular corticosteroid therapy. With plans for a next-generation formulation, Harrow is reinforcing its commitment to addressing critical ophthalmic needs and ensuring long-term patient access to essential treatments.