3-Year Posterior Non-infectious Uveitis Treatment with an Injectable Fluocinolone Acetonide Implant
Accept poster if oral is not possible ?
Yes
Purpose
To 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).
Methods
Subjects 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.
Results
There 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.
Conclusion
The 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 interest
Yes
Details of conflicting interests
G.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 name
JAFFE
Initials of first name(s)
GJ
Department
Duke Eye Center
City
Durham
Country
United States
Author 2
Last name
PAVESIO
Initials of first name(s)
CE
Department
Moorfields Eye Hospital
City
London
Country
United Kingdom
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