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As of Nov 14, 2026, NDA 22048 (Triesence), held by Harrow Eye, was first approved by FDA on Nov 29, 2007, with 1 approved supplement and 0 published complete response letters.
First approved: Nov 29, 2007
Review: Priority
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
TRIESENCE suspension is a synthetic corticosteroid indicated for:
Treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Visualization during vitrectomy. 1.1 Ophthalmic Diseases TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL is indicated for:
sympathetic ophthalmia,
temporal arteritis,
uveitis
ocular inflammatory conditions unresponsive to topical corticosteroids. 1.2 Visualization During Vitrectomy TRIESENCE suspension is indicated for visualization during vitrectomy.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
