Abstract
<jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background/objectives</jats:title> <jats:p>To assess the effectiveness and safety of 0.19-mg fluocinolone acetonide implant (FAc-implant) in inflammatory macular oedema (MO).</jats:p> </jats:sec> <jats:sec> <jats:title>Subjects/methods</jats:title> <jats:p>This observational, retrospective, multicentre cohort included consecutive eyes treated with FAc-implant between June 2020 and January 2024 for recurrent uveitic or postoperative MO requiring at least two prior dexamethasone-implants (DEX-implants) and ≥6 months of follow-up. The primary endpoints were best-corrected visual acuity (BCVA) and central macular thickness (CMT) at 6, 12, 18, and 24 months. The secondary endpoints were anatomical and functional outcomes, additional treatments and safety outcomes (intraocular pressure (IOP), ocular hypertension (OHT)).</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p> A total of 73 eyes were included, with a mean follow-up of 16.8 (8.4) months. The median difference in BCVA was +4.0 [0.0;10.0] ( <jats:italic>p</jats:italic> < 0.001), +2.0 [0.0;9.0] ( <jats:italic>p</jats:italic> = 0.006), +5.0 [0.0;10.0] ( <jats:italic>p</jats:italic> = 0.010) and +5.0 [0.0;9.0] ( <jats:italic>p</jats:italic> = 0.043) letters at 6, 12, 18 and 24 months. The median difference in CMT was -71.0 [-181.3;-25.5] ( <jats:italic>p</jats:italic> < 0.001), -71.0 [-195.0;-30.5] ( <jats:italic>p</jats:italic> < 0.001), -75.0 [194.0;-43.0] ( <jats:italic>p</jats:italic> < 0.001) and -154.0 [-253.0;-110.0] ( <jats:italic>p</jats:italic> < 0.001) μm at 6, 12, 18 and 24 months. Over the follow-up, 38 eyes (52.1%) did not require any additional intravitreal treatment. At 12 months after FAc-implant, the probability of not receiving a rescue injection of DEX-implant was 54.0% [43.0%;67.0%]. Eight eyes (11.0%) developed OHT (IOP ≥ 25 mmHg or an increase in IOP ≥ 10 mmHg), mostly resolved by IOP-lowering eye drops; two eyes required surgery. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>This real-life study shows the functional and anatomical effectiveness of the FAcimplant in recurrent inflammatory MO, with limited adverse effects and a reduced treatment burden.</jats:p> </jats:sec>