Study confirms fluocinolone acetonide insert safe, effective for NIU-PS
Three-year results from a confirmatory trial of a 36-month 0.18-mg fluocinolone acetonide intravitreal insert (Fai/Yutiq, EyePoint Pharmaceuticals) for noninfectious uveitis affecting the posterior segment (NIU-PS) confirmed the safety and effective control on NIU-PS and long-term continuous inflammation control with the insert without unanticipated side effects. In addition, the IOP elevation and cataracts were manageable, according to an on-demand presentation during 2020 AAO Virtual.
Uveitis is often chronic and requires long-term therapy to prevent secondary vision-threatening complications. For the study participants with recurrent NIU-PS were randomized to treatment with FAi or sham injection. Uveitis recurrence was the primary efficacy endpoint. One hundred and fifty-three eyes (101 FAi and 52 sham) were enrolled at 15 sites in India. During the study, uveitis recurred in 46.5% of FAi-treated eyes. Recurrence was more frequent in sham-treated eyes (75.0%), and the median recurrence time was shorter at 190.5 days. Visual acuity was stabilized or improved in approximately 90% of eyes in each group. At 36 months, macular edema was resolved in 76% of FAi-treated eyes (25/33) and 54% of sham-treated eyes (7/13). Seventy-four percent of FAi- and 73% of sham-treated eyes required IOP-lowering drops, while 2% of eyes in the FAi group and no eyes in the sham group required IOP-lowering surgery. Cataract extraction and IOL implantation was performed on 71% and 27% of phakic study eyes in the FAi and sham groups.
Jaffe GJ, et al. FAi Insert treatment for noninfectious posterior uveitis: three-year results of a confirmatory trial. Presented at: AAO 2020 Virtual [Session: OnDemand PA063.01].