July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Controlling Posterior Segment Uveitic Recurrences: Results from a Phase 3 Study of 0.18 mg Fluocinolone Acetonide Intravitreal Insert (FAi) in Subjects with Chronic Non-Infectious Uveitis Affecting the Posterior Segment
Author Affiliations & Notes
  • Quan Dong Nguyen
    Byers Eye Institute, Stanford University, Palo Alto, California, United States
  • Keyur Patel
    pSivida Corporation, Watertown, Massachusetts, United States
  • Dario A Paggiarino
    pSivida Corporation, Watertown, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Quan Dong Nguyen, AbbVie (F), Genentech (F), Gilead (F), pSivida (F), Regeneron (F), Santen (F); Keyur Patel, pSivida (E); Dario Paggiarino, pSivida (E)
  • Footnotes
    Support  pSivida Corporation; Research to Prevent Blindness, Inc (unrestricted grant to the Byers Eye Institute at Stanford University; National Eye Institute (P30-EY026877 Core Grant to the Byers Eye Institute at Stanford University)
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 418. doi:
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    • Get Citation

      Quan Dong Nguyen, Keyur Patel, Dario A Paggiarino; Controlling Posterior Segment Uveitic Recurrences: Results from a Phase 3 Study of 0.18 mg Fluocinolone Acetonide Intravitreal Insert (FAi) in Subjects with Chronic Non-Infectious Uveitis Affecting the Posterior Segment
      . Invest. Ophthalmol. Vis. Sci. 2018;59(9):418.

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

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Abstract

Purpose : Cumulative damage from repeated inflammatory episodes has been associated with significant visual morbidity in patients with non-infectious posterior uveitis (NIPU). The number of recurrences of uveitis over 1 year was compared among eyes treated with the FAi and those treated with a sham injection in a prospective, randomized, double-masked phase 3 clinical trial.

Methods : Subjects with a > 1-year history of recurrent NIPU, who had experienced at least 2 separate recurrences requiring ≥ 3 months of systemic therapy or ≥ 2 intra- or periocular steroid injections, were randomized to treatment with FAi or sham. Cumulative 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 VA; or imputed in case of missing data or rescue treatment for ocular inflammation, was compared through 1 year of the on-going 3-year clinical trial.

Results : 129 subjects (87 FAi, 42 sham) with NIPU were enrolled. During the first year of the study, the recurrence rate in FAi randomized eyes (33/87, 37.9%) was significantly lower than in sham eyes (41/42, 97.6%), p<0.001. A total of 63 recurrences were reported in FAi treated eyes (0.7±1.22/eye) versus 105 recurrences in sham treated eyes (2.5±1.67/eye). Multiple (>1) recurrences were observed in 18.4% (16/87) of the FAi treated eyes and 67% (28/42) of the sham treated eyes. Adverse events included ocular hypertension and cataract. IOP increased 1.3±3.57 and 0.2±4.17 mmHg on average in FAi and sham injection eyes, respectively.

Conclusions : Treatment with the FAi resulted in a reduced 1-year rate of uveitic recurrences as well as cumulative total recurrent episodes. Other studies are being conducted to illustrate and confirm the benefit-to-risk profile of FAi in the management of patients with NIPU.

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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