June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
An Injectable Fluocinolone Acetonide Intravitreal Insert Decreases the Incidence of Recurrence in Patients with
Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye: 12 Month Results
Author Affiliations & Notes
  • Glenn J Jaffe
    Ophthalmology, Duke University Eye Center, Durham, North Carolina, United States
  • Dario Paggiarino
    pSivida, Watertown, Massachusetts, United States
  • Gerald Riedel
    pSivida, Watertown, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Glenn Jaffe, AbbVie (C); Dario Paggiarino, pSivida (E); Gerald Riedel, pSivida (E)
  • Footnotes
    Support   None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 1232. doi:
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    • Get Citation

      Glenn J Jaffe, Dario Paggiarino, Gerald Riedel; An Injectable Fluocinolone Acetonide Intravitreal Insert Decreases the Incidence of Recurrence in Patients with
      Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye: 12 Month Results. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1232.

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

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Abstract

Purpose : Uveitis is often a chronic disease requiring long-term medical therapy. This study tested the hypothesis that
an injectable fluocinolone acetonide intravitreal insert (FAI) delivering microdoses for 36 mo. can reduce the
proportion of subjects who have a recurrence of uveitis over an extended time period after a single administration.

Methods : We conducted a phase III, multi-national, multi-center, randomized, masked, safety and efficacy study of an
FAI. The study included subjects who had been diagnosed with unilateral or bilateral chronic non-infectious uveitis
affecting the posterior segment of the eye for at least 12 mo. prior to randomization. Following the injection subjects were evaluated through 36 mo.

Results : A total of 129 subjects were enrolled in the study (all randomized population), 87 subjects and 42 subjects in
the FAI and sham injection treatment groups, respectively. All randomized subjects were included in the ITT efficacy analysis and safety populations. The proportion of subjects who had a study eye uveitis recurrence within 6 mo. of treatment was significantly lower in the FAI treatment group compared with the sham injection treatment group (ITT population: 24 [27.6%] subjects and 38 [90.5%] subjects in the FAI treatment group and the sham injection treatment group, respectively (OR: 24.94; 95% CI: 8.04, 77.39; p<0.001). The recurrence rates within 12 mo. were also significantly lower in the FAI treatment group compared with the sham injection treatment group (ITT population: 33 [37.9%] subjects and 41 [97.6%], respectively (OR: 67.09; 95% CI: 8.81, 511.06; p<0.001). Filtration surgery was required in 3 [3.4%] and 1 [2.4%] subjects, and cataract surgery in 12 [13.8] and 1 [2.4%] subjects by 12 mo. in the FAI treatment group and the sham injection treatment group, respectively. The study is still open; follow-up will continue through 36 mo.

Conclusions : The FAI very effectively reduced the number of uveitis recurrences compared to sham injection. Administration of a single FAI resulted in a 3-fold reduction in the rate of recurrence at 6 mo. compared to the sham and the effect was maintained at 12 mo. This treatment is a very promising method to provide long-term inflammation control with an office-based injection procedure and with an acceptable safety profile.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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