Harrow provides triamcinolone acetonide injectable suspension relaunch update
The second and third required PPQ batches are scheduled, and should they meet specifications, the new TRIESENCE production process will be complete, allowing Harrow to relaunch during 2024.
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Harrow has announced the successful manufacture of the first of 3 commercial-scale process performance qualification (PPQ) batches of triamcinolone acetonide injectable suspension 40 mg/mL (Triesence), 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.
In a news release, Harrow also announced 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.
Triamcinolone acetonide injectable suspension has been on the FDA Drug Shortage List for more than 5 years with all inventories having been depleted in the US market for more than 2 years.
According to the company, it remains committed to making the injectable suspension available to US ophthalmologists and retina specialists.
In the news release. Mark L Baum, chairman and CEO Officer of Harrow, confirmed the successful completion of the first of 3 batches of the injectable suspension.
“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,” he said. “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.
Moreover, Baum, noted that while the company’s initial inventory stock of triamcinolone acetonide injectable suspension not fully meet the expected demands of the market, it remains committed to collaborating closely with our manufacturing partner to expedite the production of additional batches as quickly as possible.
“Triesence has not been easily or economically replaceable during this lengthy shortage and out‑of-stock period,” he added. “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.”
Ophthalmologists, retina specialists and institutions interested in securing a quantity allocation of triamcinolone acetonide injectable suspension can complete a form for an immediate supply review.
Reference
Harrow Provides TRIESENCE® Relaunch Update. Businesswire.com. Published June 20, 2024. Accessed June 20, 2024. https://www.businesswire.com/news/home/20240620854415/en/Harrow-Provides-TRIESENCE
