Abstract
Purpose :
Non-infectious uveitis (NIU) often requires either systemic or local sustained, long-duration therapy. The fluocinolone acetonide intravitreal (FAi) insert (0.18) is used to treat chronic, non-infectious posterior uveitis by delivering a low-dose, sustained release of FAi for up to 36 months. The purpose of this study is to describe the safety related outcomes of the FAi implant in treating NIU in a real-world database.
Methods :
Patients from sixteen different clinical sites who were treated with the FAi insert were registered in a phase IV, web-based, real-world registry system to assess the impact of the insert on the patients’ overall ocular health using OCT imaging, fluorescein angiography, and visual acuity endpoints. Data is collected in three-month intervals. Safety details including intraocular pressure (IOP) and glaucoma interventions were collected and summarized.
Results :
149 patients (188 eyes) recorded a mean (±SD) age of 63.1 ± 12.7 years and 747 unique visits across all follow-ups. Of the 188 eyes enrolled, 98.4%, 1.06%, and .53% had 1, 2, and 3 Yutiq treatment per eye, respectively. 8.5% of eyes experienced an increase in IOP greater than 10 mmHg from baseline and 4.3% recorded IOP over 30 mmHg, respectively. 1.6% underwent laser trabeculoplasty and 4.3% underwent surgical interventions. As shown by Figure 1, there is no statistical difference in the IOP recorded at each follow-up visit. 53 (66%) patients experienced changes in number of glaucoma prescriptions. 50 (62.5%) experienced at least one increase in the number of glaucoma prescriptions at a subsequent follow-up visit, 33 (41.3%) experienced at least one decrease, and 27 (33.8%) experienced no change in the number of prescriptions.
Conclusions :
The overall safety of the FAi implant seen in this real world registry is comparable to the results in the phase 3 registration trials. There was no difference in the average IOP compared to baseline. A low proportion of eyes required surgical intervention to control IOP. Overall, the FAi implant was well tolerated.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.