ILUVIEN in Diabetic Macular Edema: The Choice of Second-Line Corticosteroid Should Be Left to the Clinical Judgement of the Treating Physician

Treatment choices for diabetic macular oedema: a guideline for when to consider an intravitreal corticosteroid, including adaptations for the COVID-19 era

“…In a small number of patients reported as having received a dexamethasone implant initially and a fluocinolone acetonide implant subsequently, outcomes after each have been similar (although sustained long-term effects were achieved only with the fluocinolone acetonide implant). 22 Although corticosteroid implants can result in elevated IOP in some patients, appropriate patient selection may ameliorate some of this risk because data suggest that the occurrence of prior IOP events (regardless of whether a patient has previously received a corticosteroid implant or not) may be a good predictor of subsequent IOP events with a corticosteroid implant. 22 23 Patients who do not show a significant rise in IOP with previous corticosteroid treatment have a positive predictive value of 80% for the maximum observed IOP not exceeding 25 mm Hg with the fluocinolone acetonide implant.…”

“…However, these are typically manageable and should be considered in the context of insufficiently treated DMO. The risk of raised IOP can be mitigated by appropriate patient selection (individuals with a history of elevated IOP being at higher risk for another rise) 22 23 and, if IOP does increase, it can be managed with medication (in the majority of cases) or surgery. 17 18 Similarly, cataracts-which are typically already present or developing in a significant proportion of patients with DMO-can be resolved with routine surgery.…”

<p>Clinical-Decision Criteria to Identify Recurrent Diabetic Macular Edema Patients Suitable for Fluocinolone Acetonide Implant Therapy (ILUVIEN^®) and Follow-Up Considerations/Recommendations</p>

“…It has also been previously stated that the FAc implant could be an alternative option for those DME patients that showed insufficient response to either anti-VEGF agents or short-lasting corticosteroids. 80 , 81 Owing to the insufficient response to previous treatments in Phase IV studies, the FAc implant could also be an option for patients that do not have a complete anatomical response or vision improvement after one injection of dexamethasone implant, as has been demonstrated in real-world practices, 82 because the FAc implant contains a different molecule that could induce a different response.…”

Reply to the Letter by Hall Entitled “ILUVIEN in Diabetic Macular Edema: The Choice of Second-Line Corticosteroid Should Be Left to the Clinical Judgement of the Treating Physician”

“…Dr. Hall states in his letter that he “would like to remind the readers that ILUVIEN (0.2 μg/day of FAc [fluocinolone acetonide]) is approved in Europe for the treatment of vision impairment associated with chronic DME [diabetic macular edema], considered insufficiently responsive to available therapies […]. The indication does not require a prior steroid or does not specifically state that a prior intravitreal injection of dexamethasone should be administered” [2]. The authors would like to mention that the duration of the effect of ILUVIEN is considerably longer than that of a dexamethasone implant, so that side effects, namely a steroid-induced ocular hypertension or secondary open-angle glaucoma, will have to be managed for a much longer time if ILUVIEN instead of a shorter-acting dexamethasone implant is used.…”

“…It may therefore make sense that before using the long-acting ILUVIEN, a short-acting steroid is tried to assess the effect and the presence of a steroid-induced ocular hypertension. Furthermore, as also stated by Dr. Hall, “ILUVIEN (0.2 μg/day of FAc) is approved in Europe for the treatment of vision impairment associated with chronic DME, considered insufficiently responsive to available therapies” [2]. It may indicate that an intravitreal dexamethasone implant as part of the available therapies has been used before.…”