A 0.59-mg fluocinolone acetonide intra-vitreal implant (Retisert™), has been approved for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. Uveitis is a sight-threatening inflammatory disease that primarily affects adults.
The product received both Fast Track status and Orphan Drug designation.
A tiny drug reservoir delivers sustained levels of the anti-inflammatory corticosteroid directly to the back of the eye for about 30 months.
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Adverse events included cataract progression, increased intraocular pressure, procedural complications, and eye pain.