Purpose

Three-year exploratory results from a confirmatory trial (PSV-FAI-005; clinicaltrials.gov identifier: NCT02746991) of a 36-month 0.2µg per day of fluocinolone acetonide intravitreal insert (FAi) for non-infectious uveitis affecting the posterior segment (NIU-PS).

Methods

Subjects with recurrent NIU-PS were randomized to treatment with FAi- or sham-treatment. Patients in either arm could receive adjunctive medication to treat recurrence of ocular inflammation. This primary efficacy endpoint was recurrence of uveitis at 6 months with secondary endpoints reported at Month 36. This exploratory analysis focused on efficacy and safety outcomes at Month 36.

Results

153 eyes (101 FAi and 52 sham), were enrolled at 15 sites in India. During the 3-year study, uveitis recurred in 46.5% of FAi-treated eyes (median 1116 days to the event). Recurrence was more frequent in sham-treated eyes (75.0%), and the median recurrence time was shorter (190.5 days), P < 0.001. Visual acuity was stabilized or improved in approximately 90% of eyes in each group. Macular edema was resolved in 76% of FAi-treated eyes (25/33) and 54% of sham-treated eyes (7/13) at 36 months. Seventy-four percent and 73% of FAi- and sham-treated eyes required IOP-lowering drops; 2% of eyes in the FAi group and no eyes in the sham group required IOP-lowering surgery. Cataract extraction with IOL was performed on 71% and 27% of phakic study eyes in the FAi and sham groups.

Conclusions

These results further support the efficacy and safety of long-term, continuous treatment of NIU-PS with the FAi insert