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This abstract is assigned to session Free Paper Session V: Treatment
Presentation preference Oral presentation
Title3-Year Posterior Non-infectious Uveitis Treatment with an Injectable Fluocinolone Acetonide Implant
PurposeTo provide 3-year results from a clinical trial that evaluated an injectable fuocinolone acetonide implant (FAi) to prevent relapse in non-infectious uveitis affecting the posterior segment of the eye (NIU-PS).
MethodsSubjects were randomized to receive a FAi (0.19mg; n=87) or a treated control (n=42; sham injection plus standard of care treatment). Time to first recurrence, recurrence rates, resolution of macular edema, BCVA changes, and adverse events were assessed.
ResultsThere was a longer median time to recurrence in the FAi-treated eyes (657 d) compared to sham-treated eyes (70.5 d) and fewer recurrences within 36 months compared to controls (1.7 vs 5.3 recurrences, p<0.001). Recurrence rates at months 6, 12, and 36 were significantly (p<0.001) lower in FAi-treated eyes (27.6%, 37.9%, and 65.5%, respectively), compared to controls (90.5%, 97.6%, and 97.6%) and a higher proportion of these eyes had macular edema resolution than controls (87% vs 73%). The mean VA gains were 9.1 letters and 2.5 letters in FAi and control groups, respectively. IOP-lowering drops were required in 42% and 33% of FAi and control groups.
ConclusionThe FAi provides a continuous drug microdose leading to a significantly longer time to first recurrence and significantly fewer recurrences at year 3. FAi-treated eyes benefitted from rapid and sustained macular edema resolution and greater BCVA improvements. Few adverse events were associated with the use of the FAi implant and were generally consistent with the known effects for intravitreal corticosteroids.
Conflict of interestYes
Details of conflicting interestsG.J.J.: Consultant EyePoint Pharmaceuticals, Novartis Pharma AG (Basel, Switzerland), Neurotech USA, Inc. (Lincoln, RI), Heidelberg Engineering (Heidelberg, Germany). C.E.P.: Consultant - Allergan (Dublin, Ireland), Alimera Sciences (Alpharetta, GA), EYEVENSYS (Paris, France), Servier Laboratories
(Suresnes, France), Santen Pharmaceutical Co., Ltd. (Japan), AbbVie, Inc. (North Chicago, IL).
Author 1
Last nameJAFFE
Initials of first name(s)GJ
DepartmentDuke Eye Center
CountryUnited States
Author 2
Last namePAVESIO
Initials of first name(s)CE
DepartmentMoorfields Eye Hospital
CountryUnited Kingdom