Iluvien (fluocinolone acetonide) / EyePoint Pharma, Specialised Therap, ANI Pharma - LARVOL DELTA

Fluocinolone Acetonide Implant as a Baseline Therapy for Diabetic Macular Edema: Results from the Randomized Phase 4 NEW DAY Study. (PubMed, Ther Adv Ophthalmol) - "NEW DAY compared ILUVIEN®, a fluocinolone acetonide implant (FAc), with aflibercept in people with diabetic macular edema (DME) who had minimal or no prior treatment for that condition...Side effects of FAc were as expected and were manageable. Knowing the timing of when they happened can help eye-care teams better monitor patients with DME and manage their care."

Journal • P4 data • Review • Cataract • Diabetes • Diabetic Macular Edema • Inflammation • Metabolic Disorders • Ophthalmology

Comparative Endophthalmitis Rates of Anti-VEGF, Corticosteroid Implants and Anti-Complement Injections: An IRIS® Registry Analysis. (PubMed, Am J Ophthalmol) - "The incidence of post-injection endophthalmitis is greater with corticosteroid implants and anticomplement therapies. Heightened aseptic vigilance may be warranted with injections that necessitate larger gauge needles, modulate the immune response and/or are prepared from a vial."

Journal • Ocular Infections • Ocular Inflammation • Ophthalmology • Pediatrics

Five-Year Treatment Outcomes with 0.19 µg Fluocinolone Acetonide in Radiation-Induced Maculopathy. (PubMed, Ocul Oncol Pathol) - "The potential of fluocinolone acetonide (FAc) slow-release intravitreal implants (Iluvien® implant) remains unclear...Slow-release FAc implants are a promising treatment option to improve the anatomical structure of the fovea and visual function. They may also reduce the frequency of intravitreal injections and the overall therapeutic burden."

Journal • Choroidal Melanomas • Macular Degeneration • Macular Edema • Melanoma • Ocular Melanoma • Oncology • Ophthalmology • Retinal Disorders • Solid Tumor

Delayed-onset cytomegalovirus retinitis after 0.2 µg/day fluocinolone acetonide implantation: a case series. (PubMed, J Ophthalmic Inflamm Infect) - "Delayed-onset CMVR can occur in eyes treated with FAc implants, particularly in immunosuppressed patients. Recognition of atypical presentations, early PCR testing and timely antiviral therapy are essential to preserve vision."

Journal • Cytomegalovirus Infection • Follicular Lymphoma • Genetic Disorders • Hematological Malignancies • Immunology • Lymphoma • Ocular Inflammation • Oncology • Ophthalmology • Retinal Disorders • Sarcoidosis • Uveitis • Vasculitis

Efficacy and Safety Outcomes of Fluocinolone Acetonide Intravitreal Implant in Refractory Diabetic Macular Edema: A Real-World Study. (PubMed, Ophthalmol Ther) - "These findings suggest that the FAc implant provides sustained anatomical and visual benefits with a manageable safety profile in chronic refractory DME."

Journal • Real-world evidence • Diabetic Macular Edema • Ophthalmology

Incidence and Management of Ocular Hypertension Following 0.19 mg Fluocinolone Acetonide Implants: Real-World Evidence in Diabetic Macular Edema. (ARVO 2026) - "Purpose To investigate the real-world incidence and management of ocular hypertension (OHT) following use of the intravitreal 0.19 mg fluocinolone acetonide implant (FAi, Iluvien) for diabetic macular edema (DME)...Most cases were managed medically, with surgery rarely required. These findings support the safety of FAi implants and highlight the importance of individualized IOP monitoring."

Clinical • HEOR • Real-world • Real-world evidence • Diabetic Macular Edema • Glaucoma • Ophthalmology

A novel surgical technique for repositioning a migrated fluocinolone acetonide implant through zonular dehiscence (ARVO 2026) - "Purpose To report a case of anterior chamber migration of a fluocinolone acetonide (Iluvien®) implant and describe a novel, cost-effective surgical technique for repositioning it into the posterior segment through a pre-existing zonular defect...This report introduces a novel, minimally invasive technique to gently move the implant back to its correct position using a natural gap in the eye's internal support structures. This approach successfully restored the patient's treatment without needing a new implant or extensive surgery, offering a safer and more cost-effective option for managing this complication."

Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Comparative Endophthalmitis Rates of Anti- VEGF, Corticosteroid Implant and Anti-Complement Injections: An IRIS® Registry Analysis in Adult and Pediatric Patients (ARVO 2026) - "Methods Patients in the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) who received intraocular injections of anti–vascular endothelial growth factor (VEGF) agents, fluocinolone acetonide (Iluvien, Yutiq), avacincaptad pegol (Izervay), pegcetacoplan (Syfovre), or dexamethasone (Ozurdex) were included in this analysis. Conclusions The incidence of post-injection endophthalmitis is greater with steroid implants and anticomplement therapies. Closer monitoring or more aggressive antimicrobial prophylaxis may be warranted with injections that necessitate larger gauge needles, modulate the immune response, and/or are prepared from a vial."

Clinical • Ocular Infections • Ocular Inflammation • Ophthalmology

Fluocinolone Acetonide Implant as a Baseline Therapy for Diabetic Macular Edema: Results from the Randomized Phase 4 NEW DAY Study (ScienceDirect) - "517 participants were screened, 306 randomized. Mean (SD) rescue supplemental injections were 2.4 (3.2) with FAc and 2.5 (3.1) with aflibercept (P=0.76; primary endpoint). Counting both protocol-mandated and rescue supplemental injections, the FAc group received fewer injections compared with the aflibercept group (3.4 [3.2] vs. 7.2 [3.4] injections; nominal P<0.001). Time to first rescue supplemental injection was longer with FAc than aflibercept (mean [SD] 185.4 [97.9] vs. 132.8 [94.0] days; nominal P<0.001). Proportions of participants who did not receive rescue supplemental injections were similar (32.5% vs. 30.3%; nominal P=0.68)."

P4 data • Diabetic Macular Edema

Prevalence and Risk Factors of Ocular Hypertension Following Fluocinolone Acetonide (Iluvien®) Intravitreal Injections: The "SAFAC" Study. (PubMed, Ophthalmol Ther) - "OHT occurred in approximately one in four eyes after FAc-I injection and was commonly and successfully treated with topical treatment alone or SLT in 95% of the hypertonic cases (40/42). Risk factors for OHT after FAc-I included younger age and pre-existing OHT or glaucoma. Uveitis and retinal vein occlusion were not risk factors for OHT. Previous DEX-I injection seems to be a useful predictive test. Therefore, regular IOP monitoring is essential for all patients receiving FAc-I injections, especially those with risk factors for OHT."

Journal • Cardiovascular • Diabetic Macular Edema • Glaucoma • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Uveitis

Infographic: FAME (fluocinolone acetonide for macular edema) trials of ILUVIEN® vitreous sustained-delivery inserts for diabetic macular oedema. (PubMed, Eye (Lond)) - No abstract available

Journal • Diabetic Macular Edema • Macular Edema • Ophthalmology

Tackling Macular Edema and Dislocated Intraocular Lens: The Fluocinolone-loaded IOL With Scleral Suspension (FLISS) Technique. (PubMed, Ophthalmic Surg Lasers Imaging Retina) - "After IOL removal, Gore-Tex CV-8 sutures were used to secure a 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (Iluvien) to the haptic of a Micro-pure IOL and subsequently fix the lens to the sclera...The FAc implant remained stable and well positioned outside the visual axis. The FLISS technique, herein described for the first time, offers a promising alternative for addressing chronic ME in eyes requiring secondary IOL implantation, with the benefits of no additional scleral manipulation (compared to standard IOL scleral fixation) and low risk of implant migration."

Journal • Macular Edema • Ophthalmology

Management of Anteriorly Migrated Fluocinolone 0.18 & 0.19 mg Implants Employing Scleral Suture Fixation With and Without Concomitant Implantation of a Fluocinolone 0.59 mg Implant. (PubMed, Retin Cases Brief Rep) - "The presented surgical techniques offer novel and effective methods to manage anteriorly migrated steroid implants."

Journal • Ocular Inflammation • Ophthalmology • Uveitis

Long-term outcomes of intravitreal 0.19 mg fluocinolone acetonide implant in uveitic macular edema after prior local corticosteroid treatments. (PubMed, J Ophthalmic Inflamm Infect) - No abstract available

Journal • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Beyond Vision: Prospective Real-World Evaluation of Quality-of-Life and Caregiver Burden in Diabetic Macular Edema Treated with Fluocinolone Acetonide (Iluvien®). (PubMed, Ophthalmol Ther) - "In a prospective real-world setting, Iluvien was associated with durable improvements in vision, macular anatomy, and QoL, with stable IOP. Treatment reduced the frequency of clinic visits and procedures, alleviating patient burden and caregiver absenteeism. These findings support Iluvien as a patient-centered, long-acting therapy for chronic DME and motivate multicenter validation and health-economic studies that incorporate caregiver outcomes."

HEOR • Journal • Real-world evidence • Diabetic Macular Edema • Diabetic Retinopathy • Macular Edema • Mood Disorders • Ophthalmology • Psychiatry • Retinal Disorders

Infographic: FAME (fluocinolone acetonide for macular edema) trials of ILUVIEN® vitreous sustained-delivery inserts for diabetic macular oedema. (PubMed, Eye (Lond)) - No abstract available

Journal • Diabetic Macular Edema • Macular Edema • Ophthalmology

Intravitreal fluocinolone acetonide 0.19 mg (Iluvien) implant for radiation maculopathy. (PubMed, Can J Ophthalmol) - "FAc implants were an effective treatment for RM patients who were refractory or intolerant to maximal intravitreal anti-VEGF therapy. They achieved positive results in the stabilization of macular edema and visual acuity, as well as reduced the intravitreal anti-VEGF injection burden for some patients."

Journal • Eye Cancer • Macular Degeneration • Macular Edema • Melanoma • Oncology • Ophthalmology • Retinal Disorders • Solid Tumor • Uveal Melanoma

Efficacy and safety of fluocinolone acetonide intravitreal implant (0.2 µg/day) in patients with post-surgical inflammation associated with macular edema: a case series study. (PubMed, J Ophthalmic Inflamm Infect) - "The FAc implant significantly improved both visual and anatomic outcomes, and was effective in preventing recurrences, while maintaining a reasonable safety profile, in PCME refractory to intravitreal triancinolone and dexamethasone."

Journal • Cataract • Inflammation • Macular Edema • Ophthalmology

Intravitreal Fluocinolone Acetonide Implant (ILUVIEN®) for the treatment of ocular juvenile xanthogranuloma. (PubMed, Arch Soc Esp Oftalmol (Engl Ed)) - "After numerous treatments at the 3-year follow-up, including oral steroids, repeated injections of subtenon triamcinolone acetonide and intracameral and intravitreal anti-VEGF, treatment with intravitreal fluocinolone acetonide implant (ILUVIEN®) in both eyes was decided. Evolution since then and at the 10-month follow-up has been satisfactory; the patient has not exhibited any new episodes of ocular inflammation or hyphema despite the progressive withdrawal of topical corticosteroids, and vision has remained at 20/20 in both eyes. As far as we know, this is the first case of bilateral ocular juvenile xanthogranuloma successfully treated with an intravitreal fluocinolone implant."

Journal • Inflammation • Ocular Inflammation • Ophthalmology • Uveitis

Eight-year follow-up of iluvien treated Diabetic Macular Edema (DME) patients: long term outcomes (SOE 2025) - "Iluvien may have an effect on DME beyond 3 years, as 33% (n=3) of our cohort stopped anti-VEGF and ozurdex injections 8 years after their 1st Iluviens. whilst 11% (n=1) of our cohort needed a 2nd Iluvein. 22% of patients (n=2) stayed completely intravitreal injection free at year 8."

Clinical • Diabetic Macular Edema • Glaucoma • Ophthalmology

Evaluation of fluocinolone acetonide effectiveness in managing recurrent macular edema post-pars plana vitrectomy (SOE 2025) - "This study evaluates the efficacy and safety of fluocinolone acetonide implant (0.19mg FAc, ILUVIEN®) in tackling RME in patients who underwent pars plana vitrectomy (PPV). This retrospective study analyzed variables including best-corrected visual acuity (BCVA), central macular thickness (CMT), macular volume (MV), and intraocular pressure (IOP)... FAc implant proved effectiveness in reducing CMT and MV while maintaining or improving BCVA in vitrectomized patients with RME. Ongoing vigilance is essential to track IOP fluctuations and optimize management strategies in this challenging population."

Glaucoma • Macular Edema • Ophthalmology

Insights from 15 clinical cases on the long-term management of retinal vein occlusion with Fluocinolone Acetonide intravitreal implants (SOE 2025) - "Purpose: Fluocinolone acetonide (FAc 0.19 mg, ILUVIEN®) is a long-acting corticosteroid offering a promising option for improving vision in retinal vein occlusion (RVO) patients with macular edema (ME)... FAc was effective and safe in treating ME in RVO. A third of patients required the adjunctive therapy to maintain disease control. This long-term management option for RVO patients reduced the burden of frequent IV injections that would otherwise be necessary to control the disease."

Clinical • Cataract • Macular Edema • Ophthalmology • Retinal Vein Occlusion

Fluocinolone acetonide (FAc) implant in the treatment of retinal angiopathy macular edema in ATTR V30M patients. (PubMed, Retina) - "patients with macular edema due to RAA treated with the FAc implant showed sustained increased functional results and anatomical improvement compared to baseline."

Journal • Amyloidosis • Cardiac Amyloidosis • Cataract • Macular Edema • Ophthalmology • Transplantation

Stabilizing Macular Edema Fluctuations: Outcomes of Intravitreal Fluocinolone Acetonide for Diabetic Macular Edema and Non-Infectious Uveitis. (PubMed, J Clin Med) - "This study assesses the effectiveness of intravitreal fluocinolone acetonide (FA) (Iluvien®) in treating persistent and recurrent macular edema in clinical practice at the University Hospital of Erlangen-Nuremberg, Germany...Mean BCVA remained stable in both cohorts. Intravitreal FA proved to be effective in reducing and stabilizing CRT in patients with chronic DME and NIU-PS without losing visual acuity, reducing treatment burden."

Journal • Diabetic Macular Edema • Diabetic Retinopathy • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Ethnicity & Intraocular pressure (IOP) spike rates of Diabetic Macular Edema (DME) patients: IOP outcomes after 30,172 intravitreal injections from 2014 - 2024 from a single hospital in the United Kingdom (UK) (ARVO 2025) - "IVI agents analysed include Eylea 2 mg (Aflibercept), Vabysmo (Faricimab), Avastin (Bevaziumab), Ongavia (Ranibizumab biosimilar), Lucentis (Ranibizumab), Ozurdex (Dexamethasone implant), Iluvien (Fluocinolone). Insights in the IOP spike rates of various treatment agents used for DME in diverse ethnic populations can inform clinicians on the optimal treatment agent of choice for DME patients. Additionally, it enables tailored risk stratification and patient counselling for shared decision-making."

Clinical • Diabetic Macular Edema • Glaucoma • Ocular Inflammation • Ophthalmology • Optic Neuritis