Harrow Scheduling Remaining TRIESENCE Relaunch Steps
DENVER, Colo., Jun 20, 2024 (247marketnews.com)- Harrow (Nasdaq:HROW) successfully manufactured the first of three commercial-scale process performance qualification (PPQ) batches of TRIESENCE 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’s Chairman and Chief Executive Officer, Mark L. Baum, stated, “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.”
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