After 5 years on the US Food and Drug Administration's Drug Shortage list, full production of Triesence (triamcinolone acetonide injectable suspension) 40 mg/mL, may be restarting later this year, according to drugmaker Harrow. The company reported that the first of 3 commercial-scale process performance qualification (PPQ) batches has been completed. The second and third required PPQ batches are scheduled; should these PPQ batches meet specifications, the new Triesence production process will be deemed complete, allowing Harrow to relaunch during 2024.
Triesence is 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. It has been unavailable in the United States for over 2 years.
“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,” Mark L. Baum, chairman and chief executive officer of Harrow, said in a press release. Baum noted that Harrow’s commercial leadership is initiating precommercialization activities, and said ophthalmologists or surgery centers interested in preordering Triesence can complete a form at the company’s website for an immediate supply review.
