Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, is pleased to announce the successful manufacture of the first of three commercial-scale process performance qualification (PPQ) batches of TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/ml.
A preservative-free synthetic corticosteroid that is FDA‑approved for visualization during vitrectomy and for the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids. Harrow also announced that the second and third required PPQ batches are now scheduled; and should these PPQ batches meet specifications, the new TRIESENCE production process will be deemed complete, allowing Harrow to relaunch during 2024.
TRIESENCE has been on the FDA Drug Shortage List for over five years with all TRIESENCE inventories having been depleted in the U.S. market for over two years. Harrow remains committed to making TRIESENCE available to U.S. ophthalmologists and retina specialists.
Mark L. Baum, Chairman and Chief Executive Officer of Harrow, commented, “We are delighted to confirm the successful completion of the first of three TRIESENCE PPQ batches. This milestone resulted from the commitment of teams working in South America, Europe, and the United States to reinvent the complex manufacturing and analytical testing process for TRIESENCE. We believe this work and these results improve our prospects for successfully completing the balance of the TRIESENCE qualification process and for our ability to build commercial inventories going forward. Although our initial TRIESENCE inventory build may not fully meet the expected demands of the market, we are committed to collaborating closely with our manufacturing partner to expedite the production of additional batches as quickly as possible.
“TRIESENCE, a trusted and high-utility solution for ophthalmologists and retina specialists, has not been easily or economically replaceable during this lengthy shortage and out‑of-stock period. Concurrent with our technical team completing the validation of the TRIESENCE qualification process, Harrow’s commercial leadership is initiating pre‑commercialization activities, including discussions with strategic accounts to pre‑order the expected initial inventory of TRIESENCE.”
If you are an ophthalmologist, retina specialist, or an institution interested in securing a quantity allocation of TRIESENCE, please complete the following form for an immediate supply review.
For more information please visit www.harrow.com
