Sustained drug delivery fluocinolone acetonide implant to treat severe uveitis-long term follow-up results of a compassionate use study

Glenn J. Jaffe (Durham)

Purpose: Uveitis is often a chronic disease requiring long-term therapy. We hypothesized that long-acting intravitreal corticosteroid therapy with fluocinolone acetonide would safely suppress intraocular inflammation while minimizing side effects from systemic agents. Herein we determined whether a fluocinolone acetonide sustained drug delivery implant controlled inflammation in eyes of patients with severe uveitis over a prolonged time period.
Methods: A 3-year fluocinolone acetonide sustained drug delivery system was implanted into 25 eyes of 21 patients with severe chronic posterior or pan-uveitis who did not respond adequately to, or who were intolerant to systemic immunosuppressive therapy and/or periocular steroid injection.. Patients were followed-up at regular intervals. Operative complications, intraocular inflammation level, anti-inflammatory medication use, visual acuity and IOP, were recorded.
Results: The mean postoperative followup was 20 months (range 5 – 53 months). None of the eyes had intraoperative complications. Postoperatively, 1/25 eyes had documented recurrent inflammation. There was a significant
reduction in topical, periocular, and systemic anti-inflammatory drug use: There was a significant improvement in visual acuity following device implantation (p = 0.0003);the mean pre-operative LogMar Va was 1.3 (Snellen equivalent = 20/372. The mean postoperative Va was. 75 (Snellen equivalent = 20/104). The mean preoperative IOP, 13.2 mm Hg, did not differ significantly from the postoperative IOP, 13.6 mm Hg. 13/25 eyes required therapy to lower IOP. 4 eyes required filtration surgery. There were no eyes with postoperative endophthalmitis.
Conclusions: The fluocinolone acetonide sustained drug delivery implant effectively controls inflammation in eyes with severe chronic posterior or panuveitis over an extended time period and minimizes or eliminates the
need for systemic immunosuppressive, or periocular injection therapy. This system is a promising novel alternative to currently available treatments for this challenging patient population.



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