IOP Elevation in Patients Treated With Fluocinolone Acetonide Insert for Chronic Noninfectious Uveitis Affecting the...

Characterize timing of intraocular pressure (IOP) elevation in patients treated with fluocinolone acetonide insert (FAi) for uveitis.

A post-hoc subset analysis of data from a randomized, prospective, double-masked, sham-controlled, 3-year, phase 3 clinical trial with 129 participants with noninfectious posterior uveitis randomly assigned to receive 0.18-mg fluocinolone acetonide insert or sham injection. The number of eyes with IOP of 30 mm Hg or greater at different time points were recorded.

The incidence of FAi eyes that reached IOP 30 mm Hg or greater was 17.2%. The mean number of days to first IOP response was 241. IOP elevations were divided into four time periods: under 1 month (33%), 3 to 6 months (33%), 6 to 18 months (26.7%), and greater than 18 months (6.7%). Ten cases of elevated IOP were managed medically and five required surgical management. Visual field analysis revealed no significant change in mean deviation compared to patients' own, untreated eyes (P > .05).

IOP elevations occurred in 15 out of 87 patients treated with the FAi. The onset of elevated IOP was fairly evenly distributed across the 36-month trial. Patients should be regularly evaluated for increased IOP, which can be successfully managed by traditional means. [.