FAi Insert for Treatment of Non-Infectious Posterior Segment Uveitis
JULY 30, 2019
Quan Dong Nguyen, MD, MSc
Quan Dong Nguyen, MD, MSc, professor of ophthalmology at Stanford University Medical Center, presented the results of the study, which found that treatment with a single intravitreal injection of the FAi provided anti-inflammatory treatment for 3 years in patients with non-infectious uveitis affecting the posterior segment of the eye.
To determine the 36-month safety and efficacy of a single Failure for treatment of non-infectious uveitis affecting the posterior segment of the eye, investigators carried out a controlled, prospective, double-masked trial that enrolled 129 patients from across 33 sites in the United States, Europe, Israel, and India. Investigators used a 2:1 block randomization, based on therapy, to receive FAi (87) or sham injection (42).
To be included, patients needed to have experienced at least 2 separate recurrences of non-infectious uveitis affecting the posterior segment of the eye requiring 3 or more months of systemic therapy or 2 or more intraocular or periocular steroid injections and with a history of the disease lasting 1 year or longer. The primary efficacy endpoint of the study was non-infectious uveitis affecting the posterior segment of the eye occurrence.
Investigators noted multiple secondary efficacy endpoints within their study. Secondary endpoints included visual acuity and macular thickness/edema. The safety endpoints were rates of adverse events, including incidence of cataract and elevated intraocular pressure.
The overall rate of recurrence during the study period in FAi treated eyes (56.3%, p<0.001) was significantly lower than the rate in eyes randomized to sham injection (92.9%, p<0.001). Investigators noted that visual acuity improvements of 3 or more lines was more common among the FAi treatment group (33% versus 15%). Additionally, visual acuity loss was more common among patients in the sham group (9% versus 1% sham) at the final study visit.
In eyes with baseline macular edema, 34 of 40 (85%) patients achieved resolution at month 36 when treated with FAi compared to 16 of 23 (70%) patients in the sham group.
In regard to safety, 42% of FAi and 33% of sham patients required IOP lowering medications. Investigators also noted that 6% of patients in the FAi group and 12% of patients in the sham group required IOP lowering surgery. Investigators observed cataract surgery was performed on 74% of phakic study eyes in the FAi group and on 24% of phakic eyes in the sham group.
This study, “36-Month Outcomes of Injectable Fluocinolone Acetonide Intravitreal Insert on Recurrences of Non-infectious Posterior Segment Uveitis,” was presented at ASRS 2019.