Fluocinolone Acetonide Implant Research Articles

Fluocinolone acetonide 0.18-mg implant for treatment of recurrent inflammation due to non-infectious uveitis: a case series of 15 patients

IntroductionUncontrolled non-infectious uveitis affecting the posterior segment (NIU-PS) can lead to vision loss due to repeated bouts of inflammation and consequent tissue damage. Patients with chronic NIU-PS who experience recurrent uveitis after being treated with systemic and short-acting local corticosteroids may benefit from the sustained-release 0.18-mg fluocinolone acetonide implant (FAi).MethodsIn this case series, 18 eyes with chronic, recurrent NIU-PS and cystoid macular edema (CME) treated with the 0.18-mg FAi were analyzed retrospectively. Data on patient demographics, clinical history, previous and concomitant treatments for uveitis recurrence, time to and number of uveitis recurrences, intraocular pressure (IOP), central subfield thickness (CST), and visual acuity (VA) were collected and summarized.ResultsA majority of patients (14/15 [93%]) had a history of ocular surgery, largely cataract extraction, and all developed chronic and recurrent NIU-PS and CME. At baseline, patients had a mean age of 72 years (range: 46 to 93), were 53% male, and had a mean duration of NIU-PS of 3 years (range: 1 to 19). Patients were followed for an average of 16.5 months (range: 2 to 42.5 months) post FAi. Eleven of the 18 eyes (61%) had ≥ 5 recurrences of uveitis since diagnosis, with an average time to recurrence of approximately 12 weeks (range: 1 to 27). All eyes treated with the 0.18-mg FAi showed reduced NIU-PS recurrence and visual and anatomical improvement, as measured by VA and CST, respectively. Two eyes had an IOP elevation that was managed with topical therapy, and one eye was treated with topical prednisolone for additional inflammation management. Two eyes required adjunct therapy with short-acting intravitreal corticosteroids at 7 and 16 weeks for NIU-PS recurrence after 0.18-mg FAi insertion.ConclusionAfter receiving the 0.18-mg FAi, eyes with uncontrolled NIU-PS had sustained resolution of CME and inflammation with limited need for supplementary steroid drops or injections and minimal steroid class-specific adverse effects; none required incisional IOP-lowering surgery.

Intravitreal steroid implants in the management of noninfectious intermediate and posterior uveitis

Abstract The management of intermediate and posterior uveitis poses a significant challenge of achieving adequate drug concentrations in the posterior segment over the chronic nature of the disease. Systemic agents seldom reach effective drug levels, and even with low maintenance or tapering doses, it is hard to avoid systemic toxicity. The use of intravitreal and periocular injections is often unable to prevent recurrences due to their short half-life. Since the emergence of intravitreal implants (Vitrasert, Retisert), it has become possible to circumvent these therapeutic challenges. A detailed review in the PubMed index yielded 155 articles, of which 22 were analyzed based on exclusion criteria. A recent shift from surgically sutured to minimally invasive injectable implants mainly indicated for noninfectious uveitis is evident from the literature. This review article also provides insights into dexamethasone (Ozurdex) and recent fluocinolone acetonide (Yutiq, Iluvien) implants with particular emphasis on their improved safety and efficacy. Dexamethasone implants favor the therapeutic goal of prevention of recurrences, whereas the use of fluocinolone implants helps to attain better visual outcomes due to their longer duration of action. Thus, the review provides recent literature supporting the role and indication of sustained release intravitreal implants in the management of noninfectious intermediate and posterior uveitis.

Efficacy and Safety of Fluocinolone Acetonide Implant in Diabetic Macular Edema: Practical Guidelines from Reference Center

Diabetic macular edema (DME) is a common complication of diabetic retinopathy. Treatment with intravitreal injections is effective in most cases but is associated with a high therapeutic burden for patients. This implies the need for long-term treatments, such as the fluocinolone acetonide (FAc) implant. A review of basic science, pharmacology, and clinical data was conducted to provide a state-of-the-art view of the FAc implant in 2024. Although generally well tolerated, the FAc implant has been associated with ocular hypertension and cataract, and caution should be advised to the patients in this regard. By synthesizing information across these domains, a comprehensive evaluation can be attained, facilitating informed decision-making regarding the use of the FAc implant in the management of DME. The main objective of this review is to provide clinicians with guidelines on how to introduce and use the FAc implant in a patient with DME.

Real-World Experience of Fluocinolone Acetonide 0.19 mg in the Management of Non-Infectious Uveitis

ABSTRACT Purpose This study aims to evaluate the real-world efficacy and safety profile of fluocinolone acetonide (FAc) implants for the treatment of non-infectious uveitis (NIU). Methods A retrospective, observational study was conducted at Moorfields Eye Hospital, London, involving patients who received FAc 0.19 mg implants (Iluvien®) for NIU. 2-year follow-up data on baseline characteristics, indications, and outcomes was collected. The primary indicator for treatment failure was defined as the need for rescue treatment with dexamethasone (DEX) implants, while secondary indicators included changes in steroid and systemic immunosuppression requirements, or the need for a second FAc implant before 3 years. The occurrence of complications was collected. Results Of the 146 eyes treated with FAc implants, 24.0% experienced treatment failure requiring DEX implant within 2 years. About 42.9% required this within the first 6 months. There was an increase in the number of patients requiring steroids and/or systemic immunosuppression. Within the first 2 years post-FAc implant, only 13.7% experienced an IOP rise, with 4.1% requiring IOP-lowering surgery. About 57.9% of the phakic eyes developed cataracts. Conclusion This study provides valuable real-world evidence supporting the efficacy of FAc implant in NIU. It demonstrates a good safety profile at 2 years, with a significant reduction in uveitis recurrence rate and treatment burden. Our results are especially pertinent to the treatment of uveitic cystoid macular oedema (CMO), which was the primary indication in over 75% of our patients. Furthermore, it suggests that while FAc implant controls retinal inflammation effectively, choroidal inflammation would require alternative treatment.

PRIMARY VITREORETINAL LYMPHOMA MASQUERADING AS POSTOPERATIVE ENDOPHTHALMITIS IN A PREGNANT PATIENT WITH LONG-STANDING IDIOPATHIC PANUVEITIS.

To report primary vitreoretinal lymphoma after surgical 0.59 mg fluocinolone acetonide implant (FAi) exchange in a patient treated with adalimumab for idiopathic bilateral panuveitis. Retrospective case review. A 37-year-old woman with bilateral idiopathic panuveitis, who had favorable responses to previous FAi surgical implants, presented with right eye recurrent intraocular inflammation and cystoid macular edema that partially responded to systemic adalimumab. Her FAi was replaced, given her previous favorable response. She developed postoperative ocular inflammation transiently responsive to two serial vitreous taps and injections of intravitreal antimicrobials and then worsening inflammation and new layered flocculant material. Diagnostic vitrectomy showed a few atypical lymphocytes and cultures were negative. At postdiagnostic vitrectomy Month 1, flocculant material recurred. Aqueous cytology and flow cytometry revealed large CD45-positive B cells suspicious for lymphoma. Postoperatively, she revealed that she was pregnant. She was treated with eight monthly intravitreal methotrexate injections and postpartum consolidation radiotherapy. Subsequent repeat cytology, flow cytometry, and corneal pathologic examination revealed large B cells that were CD20 positive, and next-generation sequencing detected a dominant monoclonal B-cell population, diagnostic of PVRL. Nineteen months after FAi exchange, she developed an area of enhancement in the lateral aspect of the right frontal lobe on brain MRI, consistent with central nervous system involvement. The authors present a unique case of PVRL masquerading as postoperative endophthalmitis after FAi exchange in an eye with chronic panuveitis treated with adalimumab immunosuppressive therapy. The authors hypothesize that there may be a causal relationship between adalimumab and PVRL.

Efficacy and Safety of 0.19-mg Fluocinolone Acetonide Implant in Postoperative Cystoid Macular Edema after Pars Plana Vitrectomy: The ILUCYD study

PurposeTo assess the efficacy and safety of 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) in treating chronic postoperative cystoid macular edema (PCME) after pars plana vitrectomy. DesignRetrospective multicentric case series in clinical settings. SubjectsPatients with chronic PCME who underwent vitrectomy in tertiary care centers in France. All eyes had a documented good response to the DEX implant prior to FAc implantation. MethodsReview of charts and OCT scans of patients treated with a FAc intravitreal implant. Main outcome measuresThe primary endpoints were the best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Secondary endpoints were the intraocular pressure (IOP); proportion of patients maintaining a BCVA ≥20/40; need for additional non-study treatment; differences between eyes that underwent a single and multiple surgeries and OCT biomarkers of better BCVA. ResultsForty-nine eyes of 49 patients with a mean follow-up of 24.5 ± 3.9 months were included. The mean BCVA increased from 0.40 ± 0.26 logMAR at baseline to 0.32 ± 0.24 logMAR at month 24 (M24) (p=0.0035). The mean CRT decreased from 409.37 ± 139.43 μm at baseline to 340 ± 91 μm at M24 (p=0.0001). The mean IOP was 14.0 ± 4 mmHg at baseline and remained stable at 14.03 ± 4.1 mmHg at M24 (p=0.99). During the follow-up, the IOP exceeded 21 mmHg in 9 eyes. The IOP rise was controlled with topical therapy in all eyes except one, which required cyclophotocoagulation. The BCVA was ≥20/40 in 47% of eyes (95% CI: 34%-61%) at baseline and in 58% of eyes at M24 (95% CI: 41%-73%). At M18, the likelihood of achieving a BCVA ≥20/40 was higher in eyes with intact external limiting membrane and ellipsoid zone. Additional dexamethasone implant (DEXi) was injected in 14 eyes (28.57%). The treatment burden of 2.45 ± 1.35 DEXi/year was decreased to 0.57 ± 0.60 DEXi/year after FAc implantation (p=0.001). ConclusionFAc implant improved the BCVA and reduced the CRT in eyes with chronic PCME after vitrectomy. The IOP rise could be anticipated by the previous response to corticosteroids. FAc implant in eyes with chronic PCME also allowed reducing the treatment burden.

Treatment of Noninfectious Uveitic Macular Edema with Periocular and Intraocular Corticosteroid Therapies: A Report by the American Academy of Ophthalmology

To review the evidence on the effectiveness and complications of periocular and intraocular corticosteroid therapies for noninfectious uveitic macular edema. A literature search of the PubMed database was conducted last in December 2021 and a post-assessment search was conducted in March 2023. The searches were limited to articles published in English and no date restrictions were imposed. The combined searches yielded 739 citations; 53 articles were selected for inclusion because the studies (1) evaluated periocular corticosteroid injection, intraocular corticosteroid injection or implant, suprachoroidal corticosteroid injection, or a combination thereof for uveitic macular edema; (2) had outcomes that included visual acuity (VA) or macular edema assessed clinically or imaged by OCT or fluorescein angiography; and (3) included more than 20 patients. This assessment reviewed 23 articles that provided level I or level II evidence from 18 studies on the use of periocular, suprachoroidal, and intravitreal triamcinolone acetonide injections and intravitreal dexamethasone and fluocinolone acetonide implants or inserts in noninfectious uveitic macular edema. These reports consistently demonstrated that all investigated periocular and intraocular corticosteroid therapies improved VA, macular structure, or both. One comparative study showed that intravitreal triamcinolone acetonide injection and the dexamethasone intravitreal implant had effectiveness superior to that of periocular triamcinolone acetonide injection for these outcomes. As a group, the studies highlighted the potential for these therapies to elevate intraocular pressure and to accelerate cataract formation. The published literature provides high-quality evidence that periocular and intraocular corticosteroid therapies are effective and safe for the treatment of noninfectious uveitic macular edema. However, information on the relative effectiveness and complication rates across the different therapies is limited. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

The Treatment of Diabetic Retinal Edema with Intravitreal Steroids: How and When.

Diabetic macular edema (DME) is a common complication of diabetes mellitus and a leading cause of visual impairment worldwide. It is defined as the diabetes-related accumulation of fluid, proteins, and lipids, with retinal thickening, within the macular area. DME affects a significant proportion of individuals with diabetes, with the prevalence increasing with disease duration and severity. It is estimated that approximately 25-30% of diabetic patients will develop DME during their lifetime. Poor glycemic control, hypertension, hyperlipidemia, diabetes duration, and genetic predisposition are recognized as risk factors for the development and progression of DME. Although the exact pathophysiology is still not completely understood, it has been demonstrated that chronic hyperglycemia triggers a cascade of biochemical processes, including increased oxidative stress, inflammation, activation of vascular endothelial growth factor (VEGF), cellular dysfunction, and apoptosis, with breakdown of the blood-retinal barriers and fluid accumulation within the macular area. Early diagnosis and appropriate management of DME are crucial for improving visual outcomes. Although the control of systemic risk factors still remains the most important strategy in DME treatment, intravitreal pharmacotherapy with anti-VEGF molecules or steroids is currently considered the first-line approach in DME patients, whereas macular laser photocoagulation and pars plana vitrectomy may be useful in selected cases. Available intravitreal steroids, including triamcinolone acetonide injections and dexamethasone and fluocinolone acetonide implants, exert their therapeutic effect by reducing inflammation, inhibiting VEGF expression, stabilizing the blood-retinal barrier and thus reducing vascular permeability. They have been demonstrated to be effective in reducing macular edema and improving visual outcomes in DME patients but are associated with a high risk of intraocular pressure elevation and cataract development, so their use requires an accurate patient selection. This manuscript aims to provide a comprehensive overview of the pathology, epidemiology, risk factors, physiopathology, clinical features, treatment mechanisms of actions, treatment options, prognosis, and ongoing clinical studies related to the treatment of DME, with particular consideration of intravitreal steroids therapy.

Efficacity and Safety of the Fluocinolone Acetonide Implant in Uveitic Macular Edema: A Real-Life Study from the French Uveitis Network.

To evaluate the safety and efficacy of the fluocinolone acetonide implant (FAi, Iluvien® Horus pharma, Nice, France) in non-infectious uveitic macular edema (UME) and to approach the predictive factors of treatment response. This retrospective, multicenter real-life study included patients with chronic non-infectious UME who received intravitreal FAi after at least two dexamethasone implants (DEXi). Twenty-six eyes from 22 patients (73.1% of females) were included. The mean age was 60.4 ± 16 years. The mean follow-up was 11.4 ± 2 months. The mean baseline best-corrected visual acuity (BCVA) was 0.43 ± 0.36 LogMAR, improving significantly after 1, 3, 6 and 12 months (all p < 0.05 vs. baseline). The mean baseline central macular thickness (CMT) was 429 ± 110 μm, improving significantly after 1, 3, 6 and 12 months (all p < 0.05 vs. baseline). Five eyes (19.2%) developed ocular hypertension during the follow-up, requiring initiation or strengthening of intraocular pressure lowering medication. The majority of eyes (77%) did not require any rescue DEXi during the available 12-month follow-up. The resolution of UME after DEXi seemed to predict the anatomical response after FAi. The baseline presence of a disorganization of the inner retinal layers (DRIL) and hyperreflective foci (HRF) were both associated with a higher likelihood of requiring rescue DEXi injections. FAi implantation led to a significant BCVA and CMT improvement with a good safety profile over the 12-month follow-up. Predictive factors of treatment outcomes seem to include the anatomical response to DEXi and the presence of DRIL and HRF at baseline.

Successful Treatment of Clinically Diagnosed Cancer-Associated Retinopathy with Intravitreal Dexamethasone Implant Followed by 0.18 mg Fluocinolone Implant without Systemic Immunosuppression.

To report a case of clinically diagnosed cancer-associated retinopathy (CAR) successfully treated with intravitreal corticosteroid implants without systemic immunosuppression. Case report with multimodal imaging. An 80-year-old man without known systemic malignancy presented with debilitating shimmering, hemeralopia and rapidly progressive bilateral vision loss following uncomplicated cataract surgery. Mild vitritis, extensive photoreceptor loss, mottling of retinal pigmentary epithelium (RPE), and mild vascular attenuation were found in both eyes. Full field electroretinogram (ffERG) showed severe bilateral rod-cone dysfunction. Infectious etiologies and vitreoretinal lymphoma were ruled out. During cancer workup, intravitreal corticosteroid treatment was offered. Significant anatomical improvement with reconstitution of ellipsoid zone, improved RPE irregularities and functional improvement, were observed 3 weeks after bilateral intravitreal dexamethasone implants (Ozurdex). 2 months later, patient received bilateral intravitreal 0.18mg fluocinolone acetonide implants (YUTIQ). Later, a colonic adenocarcinoma was found (pathologic stage pT3 pN0). Patient recovered well from surgery and no chemotherapy was needed. 9 months since bilateral intravitreal fluocinolone acetonide implants (11 months since bilateral intravitreal dexamethasone implants), best corrected vision maintained at 20/25-2 OD, 20/20 OS without ongoing treatments. Bilateral reconstitution of ellipsoid zones and nearly resolution of RPE irregularities remained stable. Repeat ffERG demonstrated improved cone response OS and stable diminished rod response OU. Patient reports resolution of ocular symptoms. The sustained improvements with intravitreal corticosteroid monotherapy suggest potential advantages using local therapy over systemic treatment. Long term follow-up is warranted. Further research is needed to evaluate the efficacy of using 0.18mg fluocinolone implant (YUTIQ) to treat CAR.

Long-Term Clinical Outcomes of the 0.18 Mg Fluocinolone Acetonide Intravitreal Implant Following Local Corticosteroid Burst in Noninfectious Uveitis

ABSTRACT Purpose The 0.18 mg fluocinolone acetonide implant (FAi) is marketed for up to 36 months for treatment of noninfectious uveitis. An additional short-term corticosteroid burst prior to the 0.18 mg FAi, followed by attempt at long-term inflammation control with the 0.18 mg FAi may be beneficial given the low dose of the implant. We retrospectively reviewed all patients undergoing this treatment approach at our institution to determine its efficacy. Methods Patients who received a corticosteroid burst followed by the 0.18 mg FAi with at least 6-month follow-up post 0.18 mg FAi were included. The primary outcome, treatment escalation (defined as worsening inflammation requiring escalation of therapy), was modeled using Kaplan-Meier analysis. Secondary outcomes included cystoid macular edema (CME), central macular thickness, retinal vasculitis, visual acuity, anterior chamber and vitreous cell, use of systemic therapy, use of corticosteroid drops, IOP, number of IOP lowering medications, need for glaucoma surgery, need for cataract surgery, and additional local corticosteroids. Results 32 eyes were included (mean follow-up: 19.8 months). Prior to corticosteroid burst, 37.5% were on systemic therapy, 53% had CME, and 25% had retinal vasculitis. At FAi visit, CME had decreased to 18.8%. Mean time to treatment escalation after FAi was 20.3 months (95% CI 14.8–25.7 months). No patient discontinued systemic therapy and on average 15.0% of eyes required additional local corticosteroids at each follow-up interval. Conclusions This treatment approach demonstrates that the 0.18 mg FAi is a useful adjuvant for the treatment of noninfectious uveitis but may not be adequate as solo therapy.

ILUVIEN® in diabetic macular edema that persists or recurs despite treatment: Results from the Retina.pt® RIVER audit.

Persistent diabetic macular edema (DME) remains a problem in clinical practice, with many patients having a suboptimal response to the standard of care (SOC). Evidence supports the long-term efficacy of intravitreal fluocinolone acetonide (FAc) implant (ILUVIEN®) in patients that have responded sub-optimally, although there is still scarce data from real-world Portuguese practices. We aimed to monitor the current SOC in selected Portuguese practices prior to FAc implantation and then assess the long-term effectiveness and safety of the FAc implant. The study included patient data from five Portuguese public hospitals. This was a non-interventional, multicenter audit of data collected from Retina.pt registry from patients with persistent or recurrent DME despite treatment. Outcome measures included changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP). Results were compared at regular times over 36 months. This study included 222 eyes from 152 patients. A significant decrease in BCVA (P < 0.001) and a significant increase in CMT (P = 0.013) were observed prior to FAc. A significant increase in BCVA was registered at 6 months after FAc implant administration (P < 0.001), which was maintained during follow-up. No relevant changes in IOP were observed. Treatment burden was reduced as a result of treatment with FAc (P < 0.001 for anti-VEGF, corticosteroids, or both treatments) in the full population. In Portuguese practice, data showed that pre-FAc implantation, some patients did not respond to SOC treatment and/or they were undertreated. Following FAc implant administration, there were rapid, sustained, long-term visual and anatomical improvements, and a marked reduction in treatment burden.

Treatment of Intermediate Uveitis-associated Retinal Vasoproliferative Tumors: A Case Series.

To report the use of combination intravitreal pharmacotherapy using anti-vascular endothelial growth factor (VEGF) and short and long-term corticosteroid implants for the treatment of retinal vasoproliferative tumors (VPT) associated with intermediate uveitis. Retrospective chart review of patients with VPT secondary to idiopathic intermediate uveitis that underwent combination intravitreal pharmacotherapy at a single center was performed. Multimodal imaging including ultrawide field color fundus photography, ultrawide field fluorescein angiography, and optical coherence tomography obtained before and after treatment were reviewed. Four eyes of 4 patients were treated with multiple injections of a combination of aflibercept, dexamethasone, and fluocinolone acetonide implants for VPT associated with intermediate uveitis. All 4 patients had improvement in visual acuity, intraocular inflammation, central macular thickness, and retinal vascular leakage, as well as regression of the VPT and reduction in lesion leakage on follow-up. Combination intravitreal anti-VEGF and corticosteroid implants may be a useful approach for the treatment of intermediate uveitis-associated VPTs and can lead to both functional and structural improvement.

The 0.2-μg/day Fluocinolone Acetonide Intravitreal Implant in Chronic Noninfectious Posterior Uveitis: A 3-year Randomized Trial in India

To examine the long-term efficacy and safety of the intravitreal 0.2-μg/day fluocinolone acetonide implant (FAi) to treat noninfectious uveitis (NIU) of the posterior segment (PS). Three-year, phase III, multicenter, randomized, double-masked, controlled, prospective study (clinicaltrials.gov, NCT02746991). Overall, 153 patients in India with NIU-PS in ≥ 1 eye (with or without anterior uveitis) for ≥ 1 year who had ≥ 2 separate recurrences of uveitis requiring ocular injections or systemic therapy in the prior 12 months. Patients were randomized 2:1 for baseline FAi or sham injection and monitored for main outcome measures. Incidence and timing of uveitis recurrence, use of adjunctive therapy, best-corrected visual acuity, central foveal thickness, and monitoring of intraocular pressure (IOP)- and cataract-related events over 36 months. Overall, 153 patients (FAi, n = 101; treated sham, n = 52) were enrolled. Fluocinolone acetonide implant-treated eyes had significantly reduced uveitis recurrence rates versus treated sham (46.5% vs. 75.0%, respectively; P= 0.001) and a longer median time to recurrence (1116.0 [95% confidence interval, 847.00 to not evaluable] vs. 190.5 [95% confidence interval, 100.0-395.0] days for treated sham). Systemic adjunctive treatments were similar between groups, but fewer FAi-treated eyes required adjunctive injections (8.9% vs. 51.9% for treated sham). Visual outcomes were similar between groups, and residual macular edema was more common at 36 months in treated sham versus FAi-treated eyes (46.2% vs. 24.2%, respectively). The FAi-treated group had a lower central foveal thickness from month 12 onward. Intraocular pressure-lowering surgeries were stable in both groups, but, as expected, rates of IOP elevations were more frequent in the FAi-treated group than in the treated sham (IOP > 25 mmHg: 23.8% vs. 3.8%; IOP > 30 mmHg: 16.8% vs. 1.9%, respectively), and FAi-treated eyes had a higher incidence of cataract surgery than the treated sham (70.5% vs. 26.5%, respectively). In patients with NIU-PS, the 0.2-μg/day FAi is associated with reduced-uveitis recurrence and increased time to first recurrence while controlling macular edema, maintaining stable IOP levels, and providing an expected safety profile, including a higher occurrence of cataract formation over 36 months. The authors have no proprietary or commercial interest in any materials discussed in this article.

Retinal changes after fluocinolone acetonide implant (ILUVIEN®) for DME: SD-OCT imaging assessment using ESASO classification.

A detailed understanding of the anatomical and structural changes occurring in the retina following intravitreal fluocinolone acetonide implantation may help improve the management and prognosis of persistent or recurrent diabetic macular edema (DME). Overall, 45 eyes (from 35 patients) with refractory center-involved DME received an intravitreal fluocinolone acetonide implant. They were monitored at baseline and at 6, 12, 24, and 36 months for best-corrected visual acuity (BCVA), central foveal thickness (CFT), and the seven retinal parameters used in the classification of diabetic maculopathy recently developed at the European School for Advanced Studies in Ophthalmology (ESASO). Within 6 months of implantation, significant improvements were evident in BCVA, CFT, maculopathy stage, and the percentage of eyes with: intraretinal cysts; CFT > 30% above the upper normal value; and disrupted or absent ellipsoid zone (EZ) and/or external limiting membrane (ELM). Significant improvements were still maintained at 36 months post-implantation. At month 36, early treatment with the implant (i.e., after < 6 previous intravitreal injections for DME) trended toward being more effective than later treatment in improving BCVA, CFT, maculopathy stage, and the percentage of eyes with CFT > 30% above the upper normal value. However, statistical significance was not achieved. In persistent or recurrent DME, fluocinolone acetonide implantation can be effective in improving maculopathy stage and reducing the percentage of eyes with: intraretinal cysts; CFT > 30% above the upper normal value; and disrupted or absent EZ and/or ELM. It can also increase BCVA and reduce CFT.

Functional and Morphological Responses to Fluocinolone Acetonide 0.19 mg in Noninfectious Uveitic Macular Edema Evaluated as the Area-Under-the-Curve.

Purpose: This study investigated the impact of baseline clinical and optical coherence tomography (OCT) factors on the response to a 0.19-mg fluocinolone acetonide (FAc) implant in patients with noninfectious uveitic macular edema evaluated by the area under the curve over 24 months. Methods: A retrospective study was conducted of eyes of patients with noninfectious uveitic macular edema undergoing FAc treatment, with follow-up from baseline to 24 months. The area under the curve (AUC) of best-corrected visual acuity (BCVA) and the central macular thickness (CMT) were calculated using the trapezoidal rule. Clinical and OCT data at the time of FAc administration were collected, and associations with AUC of BCVA and CMT changes were investigated. Results: Twenty-three patients were enrolled. BCVA and CMT significantly improved after FAc implantation (P < 0.05). AUCBCVA and AUCCMT were 0.41 ± 0.33 logarithm of minimal angle of resolution/6 months and 320.15 ± 321.64 μm/6 months, respectively. Better baseline BCVA (coefficient [coef.] = 0.83, P < 0.001) and macular thickness reduction after FAc administration (coef. = -0.0001, P < 0.05) were associated with better BCVA after FAc treatment. In contrast, baseline OCT biomarkers such as ellipsoid zone reflectivity and choroidal vascularity index, sex, or disease duration before FAc injection showed no correlation with AUCBCVA and AUCCMT (P > 0.05). The younger the patient at the time of FAc injection, the greater the reduction in CMT (coef. = 1.76, P < 0.05). Conclusions: Among all clinical and morphological baseline factors, Baseline BCVA was the strongest predictor for AUCBCVA, while no association with baseline OCT features was observed. Overall, improvement of BCVA and CMT after FAc injection was maintained over 24 months. This study is registered in the German Clinical Trials Register under the DRKS-ID: DRKS00024399.

Intravitreal Fluocinolone Acetonide Implant (ILUVIEN®) for the Treatment of Retinal Conditions. A Review of Clinical Studies.

Fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) is a corticosteroid implant indicated for the treatment of diabetic macular oedema (DMO) in patients who have previously received conventional treatment without good response, non-infectious posterior uveitis, and as an off-label treatment of the macular oedema secondary to retinal vein occlusion. FAc is a non-biodegradable 0.19 mg intravitreal implant which is designed to release FAc over 3 years at a rate of approximately 0.2 mcg per day. The aim of this review is to describe the special pharmacological properties of Iluvien and display the outcomes of the most important clinical trials and real-world studies regarding its efficacy and safety for the management of the above retinal disorders.

Alternative technique for the injection of fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) in case of leakage of its injector.

To show an alternative surgical technique for the introduction of the intravitreal fluocinolone acetonide (FAc) implant (Iluvien®) into the vitreous cavity using a 23-gauge (G) trocar if it is retained during its implantation in the subconjunctival space. We describe the surgical procedure performed to solve the complication: The FAc implant was extracted from the subconjunctival space using flat retinal forceps. A 23-G trocar was inserted 3,5 mm to the limbus. The same flat retinal forceps were used to take the FAc implant and introduce it into the vitreous cavity using a 23-G trocar. The patient's best corrected visual acuity (BCVA) (Snellen) improved from 20/200 to 20/63 and the central macular thickness (CMT) was reduced from 610 microns (µm) to 215 µm after one week of the FAc implantation. He remained stable after 3 months of follow-up, with a BCVA of 20/63 and a CMT of 191 µm. His intraocular pressure (IOP) remained stable and the integrity of the implant was checked by indirect ophthalmoscopy. The introduction of the intravitreal FAc implant using a 23-gauge trocar constitutes a valid alternative if it is retained during its implantation in the subconjunctival space.The functionality of the implant remained intact in our patient.

Fluocinolone acetonide 0.19-mg implant for the treatment of noninfectious uveitis with involvement of the posterior segment: a real-world study

PurposeTo evaluate the effectiveness of 0.19-mg fluocinolone acetonide implant (FAi) for preventing inflammatory relapses in noninfectious uveitis with posterior segment involvement in standard clinical practice. Further, to assess the value of remission induction therapy with intraocular and periorbital administered high-dose corticosteroids before FAi.MethodsA retrospective cohort study in a tertiary referral center specialized in uveitis management. The primary study outcomes were the best-corrected visual acuity (BVCA) and central retinal thickness (CRT) within a 12-month observation period. The secondary outcomes were intraocular pressure (IOP) and intraocular inflammation. The main safety measures were IOP increase and cataract formation.ResultsIn total, 76 eyes of 57 patients received FAi. Locally administered high-dose corticosteroids were applied in 68.4% of all eyes before FAi. BCVA remained stable within the 12-month observation period (63.21 vs. 62.95, difference 0.26 letters; 95% CI: − 6.31 to 6.84; p > 0.9). Significant CRT reduction upon FAi was sustained after 12 months (362.7 vs. 309.1 μm, difference 53.57 μm; 95% CI: 1.55 to 105.6; p = 0.04). Intraocular inflammation was reduced until 9 months of follow-up (0.82 vs. 0.3, difference 0.53; 95% CI: 0.11 to 0.95; p = 0.007). A mean IOP increase (13.68 vs. 15.6; difference − 1.92; 95% CI: − 3.85 to 0.004; p = 0.0507) and cataract development (20% of all phakic eyes) were noted.ConclusionWe observed similar levels of FAi effectiveness for the treatment of noninfectious uveitis in standard clinical practice compared to previous randomized clinical trials. Moreover, remission induction therapy before FAi can benefit patients with increased baseline uveitis activity.

Safety and effectiveness of the fluocinolone acetonide intravitreal implant (ILUVIEN): 3-year results from the European IRISS registry study

BackgroundThe ILUVIEN Registry Safety Study was a multicentre, open-label, non-randomised, observational, phase 4 study designed to assess the safety and effectiveness of the fluocinolone acetonide (FAc) implant in all indications...