July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Safety and Efficacy of an intravitreal 0.18 mg fluocinolone acetonide insert (FAi) for the treatment of non-infectious posterior segment uveitis (NIPU) – pooled results of two phase 3 trials
Author Affiliations & Notes
  • Eric B Suhler
    Casey Eye Institute-OHSU and VA Portland HCS, Portland, Oregon, United States
  • Footnotes
    Commercial Relationships   Eric Suhler, Abbvie (F), Abbvie (C), Abbvie (R), Aldeyra (F), Bristol Myers Squibb (F), Clearside (F), EyeGate Pharmaceuticals (F), Inotek (C), pSivida (F), Santen (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 5952. doi:
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      Eric B Suhler; Safety and Efficacy of an intravitreal 0.18 mg fluocinolone acetonide insert (FAi) for the treatment of non-infectious posterior segment uveitis (NIPU) – pooled results of two phase 3 trials. Invest. Ophthalmol. Vis. Sci. 2018;59(9):5952.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Treatment of NIPU includes intraocular, periocular or systemic corticosteroid and/or systemic immunomodulatory drugs. The 6 month safety and efficacy results from two prospective, randomized, double-masked phase 3 clinical trials were pooled and analyzed.

Methods : Subjects with a > 1 year history of recurrent NIPU, who had experienced at least 2 separate recurrences requiring ≥ 3m systemic therapy or ≥ 2 intra- or periocular steroid injections, were randomized to treatment with FAi or sham injection. The primary efficacy endpoint was recurrence of uveitis, defined as 1) ≥ +2 increase in anterior chamber cells; or 2) ≥ +2 increase in vitreous haze; or 3) ≥ 15 letter loss of visual acuity (VA); or imputed in case of missing data or rescue treatment for ocular inflammation. VA and macular thickness/edema were secondary efficacy outcomes. Safety results included rates of adverse events including, but not limited to, cataract and elevated IOP.

Results : Investigators in the US, Europe, Israel and India enrolled 282 subjects (188 FAi, 94 sham) in the 2 studies. During the first 6 months, the recurrence rate in FAi randomized eyes (26.6%) was significantly (p<0.001) lower than in sham eyes (73.4%). VA improved by an average of 6.0 and 4.4 letters in FAi and sham eyes respectively. At month 6, macular edema was resolved in 65.9% (54/82) of FAi eyes and 39.1% (18/46) of sham eyes. Through month 6, 12.2% and 4.3% of FAi and sham treated eyes experienced an IOP increase ≥12 mm Hg and 2 of the FAi study eyes required IOP lowering surgery. Cataract surgery was performed on 6.8% and 8.9% of phakic study eyes in the FAi and sham groups respectively.

Conclusions : Study eyes in the FAi treatment group had a reduced rate of NIPU recurrence and a higher rate of macular edema resolution than the sham treatment group. Rates of elevated IOP were higher in FAi treated eyes at 6 months.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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