Fluocinolone acetonide intravitreal implant (FAc) has been recommended within its marketing authorisation, while the evidence submitted did not include any relevant comparators and was supported by a likely biased effectiveness estimation.

The clinical trial results for the FAc intravitreal implant compared with (limited) current practice were difficult to interpret and were very uncertain.

The benefit–risk ratio for FAc (when compared with no treatment) seemed good. However, the effectiveness of FAc compared with active comparators was unclear due to the imputation methods and the comparator used in the trial. This uncertainty was not propagated into the probabilistic sensitivity analysis, but the impact of that uncertainty on the results was extensively explored by the Evidence Review Group through scenario analyses.