Christensen, Louise Fischer

Vorum, Henrik

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Aalborg UniversitetReal-world safety and efficacy of 0.19 mg fluocinolone acetonide intravitreal implant inthe management of recurrent non-infectious uveitisChristensen, Louise Fischer; Vorum, HenrikCreative Commons LicenseUnspecifiedPublication date:2022Document VersionPublisher's PDF, also known as Version of recordLink to publication from Aalborg UniversityCitation for published version (APA):Christensen, L. F., & Vorum, H. (2022). Real-world safety and efficacy of 0.19 mg fluocinolone acetonideintravitreal implant in the management of recurrent non-infectious uveitis. Poster presented at DanskOftalmologisk Selskabs Videnskab og Generalforsamling, Middelfart, Denmark.General rightsCopyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright ownersand it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights.            - Users may download and print one copy of any publication from the public portal for the purpose of private study or research.            - You may not further distribute the material or use it for any profit-making activity or commercial gain            - You may freely distribute the URL identifying the publication in the public portal -Take down policyIf you believe that this document breaches copyright please contact us at vbn@aub.aau.dk providing details, and we will remove access tothe work immediately and investigate your claim.Downloaded from vbn.aau.dk on: January 13, 2026Real-world safety and efficacy of 0.19 mg fluocinolone acetonide intravitreal implant in the management of recurrent non-infectious uveitisLouise Fischer Christensen, Henrik VorumDepartment of ophthalmology, Aalborg University Hospital, Aalborg, DenmarkThe 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien®) was recently approved in several European countries for the treatment of recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The device releases a continuous low dose of corticosteroid into the vitreous for up to 36 months and thus offers a systemic therapy-sparing treatment option. Clinical trial data have shown promising efficacy and an acceptable safety profile1. Real-world studies are now starting to emerge, supplementing clinical trial results by providing valuable data on outcomes in everyday clinical practice.Introduction1 Jaffe GJ, Pavesio CE. Effect of fluocinolone acetonide insert on recurrence rates in noninfectious intermediate, posterior, or panuveitis: three-year results. Ophthalmology 2020; 127: 1395-1404.2 Ajamil-Rodanes S, Testi I, Luis J, et al. Evaluation of fluocinolone acetonide 0.19 mg intravitreal implant in the management of birdshot retinochoroiditis. Br J Ophthalmol 2022; 106: 234-240.3 Battista M, Starace V, Cicinelli MV, et al. Efficacy of 0.19 mg fluocinolone acetonide implant in non-infectious posterior uveitis evaluated as area under the curve. Ophthalmol Ther 2022; 11: 215-224.4 Hikal M, Celik N, Auffarth GU, et al. Intravitreal 0.19 mg fluocinolone acetonide implant in non-infectious uveitis. J Clin Med 2021; 10, 3966.5 Kriegel M, Heiligenhaus A, Heinz C. Comparing the efficacy of intravitreal dexamethasone and time-displaced fluocinolone acetonide on central retinal thickness in patients with uveitis. Ocul Immunol Inflamm 2022; 1-7.6 Pockar S, Leal I, Chhabra R, et al. Intravitreal fluocinolone 0.19mg implant in the management of chronic non-infectious uveitis: 12-month outcomes from a single tertiary centre. Ocul Immunol Inflamm 2021; 1-7.7 Studsgaard A, Clemmensen KØ, Nielsen MS. Intravitreal fluocinolone acetonide 0.19 mg (Iluvien®) for the treatment of uveitic macular edema: 2-year follow-up of 20 patients. Graefe’s Arch Clin Exp Ophthalmol 2022; 260: 1633-1639.8 Weber LF, Marx S, Auffarth GU, et al. Injectable 0.19-mg fluocinolone acetonide intravitreal implant for the treatment of non-infectious uveitic macular edema. J Ophthalmic Inflamm Infect 2019; 9: 3.SReferences6 real-world studies were eligible for inclusion, comprising a total of 91 patients (113 eyes)2,3,4,5,6,7. A seventh eligible study was identified, but data overlapped with the findings of another included study (Hikal et.al) and were therefore excluded8. Below, we present preliminary results from the systematic review.ResultsConclusionUveitic macular edema (UME)AimTo review the current landscape of real-world evidence on the use of Iluvien® for the treatment of recurrent NIU-PS in terms of:1) Efficacy outcomes (macular edema, visual acuity, recurrences)2) Safety outcomes (intraocular pressure, need for cataract surgery, other)MethodsSystematic literature review adhering to PRISMA guidelines. Searches were carried out in PubMed, EMBASE and Web of Science from database inception until 2nd July 2022. Visual acuity (VA) Intraocular pressure (IOP)050100150200250300350400450500Battista et.al. Hikal et.al. Pockar et.al. Studsgaard et.al.Central retinal thickness, mean (µm)Baseline <3 months 6 months 12 monthsCorrespondence: louise.fischer@rn.dkFigure 1. Four of six studies provided data on mean central retinal thickness at baseline and during the first year of treatmentRecurrence ratesThe studies by Hikal et.al. and Studsgaard et.al. provided data beyond the first year; improvements in mean CRT were sustained at 36 and 24 months, respectively.The remaining studies not presented in Figure 1:1) Kriegel et.al.: median CRTAt baseline: 455 µmAt 3 months follow-up: 345 µm (p=0.0008)2) Ajamil-Rodanes et.al. (birdshot chorioretinitis only): 3 patients had UME at baseline, which resolved in all patients after injection of Iluvien®. There were no UME recurrences during 36 months of follow-up.In all included studies, mean or median visual acuity was either stable or improved within the first year after Iluvien® implantation.Table 1. Four of six studies provided data on mean VA (logMAR) at baseline and during the first year of treatmentAn improvement in mean or median central retinal thickness (CRT) was observed in all studies within the first year after Iluvien® implantation.Baseline <3 months 6 months 12 monthsAjamil-Rodanes et.al. 0.16 0.17 0.15 0.15Battista et.al. 0.67 0.54 0.51 0.45Pockar et.al. 0.48 0.40 0.49 0.45Studsgaard et.al. 0.38 NA 0.23 0.21The remaining studies not presented in Table 1:1) Kriegel et.al.: median VA (logMAR)At baseline: 0.52At 3 months follow-up: 0.40 (p=0.0005)2) Hikal et.al.: 58.5% of eyes improved VA, 26.5% remained stable and 14.7% experienced worsening of VA (measured as maximal change of VA during follow-up).Follow-up UME relapseAjamil-Rodanes et.al. Up to 36 months 0 of 3 eyes (0%)Battista et.al. 12 months 0 of 10 eyes (0%)Hikal et.al. Up to 60 months 5 of 34 eyes (14.7%)Kriegel et.al. 3 months 0 of 23 eyes (0%)Pockar et.al. 12 months 2 of 11 eyes (18.1%)Studsgaard et.al. Up to 24 months 4 of 14 eyes (28.6%)Table 2. Proportion of eyes in each study with relapse of UME Other safety outcomes024681012141618Ajamil-Rodaneset.al.Battista et.al. Hikal et.al. Kriegel et.al. Pockar et.al.Intraocular pressure, mean (mmHg)Baseline <3 months 6 months 12 monthsFigure 2. Five of six studies provided data on mean IOP at baseline and during the first year of treatmentA minority of patients required IOP lowering treatment after injection of Iluvien® (see Table 3). Most were glaucoma patients or patients with a history of steroid induced ocular hypertension.Study Topical Systemic carbon anhydrase inhibitorSurgeryAjamil-Rodanes et.al. 5 (33.3%) 0 0Battista et.al. 1 (10%) 0 0Hikal et.al. 3 (8.8%) 0 0Kriegel et.al. 1 (4.3%) 0 0Pockar et.al. 1 (9,1%) 0 0Studsgaard et.al. 0 2 (10%) 2 (10%)Table 3. Number of eyes that required additional IOP lowering treatment after injection of Iluvien®, some only temporarily14 of 15 phakic eyes with a clear lens at baseline developed cataract during follow-up. 1 study did not report on lens status3.Hypotony: 3 eyesRetinal detachment: 1 eye (3 months after Iluvien® injection)No other adverse events were reportedThe currently existing real-world data support that Iluvien® is an effective treatment for achieving quiescence in uveitic activity in a selected group of patients with recurrent NIU-PS. Overall, Ilvuien® improved mean or median CRT, visual acuity (mean or median) was either stable or improved, recurrence rates were low and the treatment generally reduced the need for systemic therapy. Adverse effects were manageable (increased IOP, cataract formation, hypotony). Retinal detachment occurred in 1 patient 3 months after injection of Iluvien®. Cataract formation should be expected following Iluvien® implantation. The reported real-world data are overall in accordance with clinical trial findings1.More real-world evidence is needed to support the above findings. There is especially a need for data with long-term follow-up. 

Real-world safety and efficacy of 0.19 mg fluocinolone acetonide intravitreal implant in the management of recurrent non-infectious uveitis

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Real-world safety and efficacy of 0.19 mg fluocinolone acetonide intravitreal implant in the management of recurrent non-infectious uveitis

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