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

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

ANI Pharmaceuticals Announces Buyout of Royalty Obligation for ILUVIEN and YUTIQ (GlobeNewswire) - "ANI Pharmaceuticals, Inc...announced that it has completed the buyout of its 3.125% perpetual royalty obligation to SWK Funding LLC (SWK) on worldwide net revenues of ILUVIEN and YUTIQ for a one-time payment of $17.25 million. Under the terms of the agreement, upon making the buyout payment, no further royalty is due to SWK on net revenues beginning January 1, 2025, forward. ANI funded the buyout with cash on hand."

Commercial • Diabetic Macular Edema • Uveitis

ANI Pharmaceuticals Announces FDA Approval for Expansion of ILUVIEN Label (GlobeNewswire) - "ANI Pharmaceuticals, Inc...today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The approval also includes other updates to the label including to the Warnings and Precautions section."

FDA approval • Uveitis

ANI Pharmaceuticals Reports Record Fourth Quarter and Full-Year 2024 Financial Results and Raises 2025 Guidance (GlobeNewswire) - "Revenues for ILUVIEN and YUTIQ were $27.6 million for the fourth quarter, which was the first full quarter of ownership following the acquisition of Alimera Sciences...The Company has submitted a prior approval supplement (PAS) to the FDA seeking to add YUTIQ’s indication of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) to the ILUVIEN label. The Company expects FDA approval of the PAS in the second quarter of 2025 and plans to market ILUVIEN for chronic NIU-PS in addition to its current indication of diabetic macular edema (DME) in the U.S."

Commercial • FDA event • Launch US • Diabetic Macular Edema • Uveitis

Ophthalmic corticosteroids-related adverse events: the FDA adverse event reporting system (FAERS) database pharmacovigilance study. (PubMed, Front Pharmacol) - "A total of 9,854 ADRs related to ophthalmic corticosteroids were retrieved, with the most frequently reported drugs being Ozurdex (1,784 cases), Lotemax (3,239 cases), and Durezol (2,789 cases)...Additionally, Maxidex has been linked to endocrine disorders, while Ozurdex, Iluvien, and Triesence exhibited significant signals for product issues, likely related to their intraocular injection procedures...These findings highlight the need for careful monitoring and individualized treatment plans to minimize the risk of ADRs in patients receiving corticosteroid therapy. Future studies combining FAERS data with large-scale clinical research are needed to explore these safety concerns further."

Adverse events • Journal • Cataract • Endocrine Disorders • Infectious Disease • Inflammation • Ocular Inflammation • Ophthalmology • Pain • Retinal Disorders • Uveitis

Intravitreal steroid implants in the management of noninfectious intermediate and posterior uveitis. (PubMed, Indian J Ophthalmol) - "Since the emergence of intravitreal implants (Vitrasert, Retisert), it has become possible to circumvent these therapeutic challenges...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."

Journal • Ocular Inflammation • Ophthalmology • Uveitis

Real-life results after the administration of a single 0.19 mg fluocinolone acetonide (ILUVIEN®) implant in patients with refractory diabetic macular edema. (PubMed, Ophthalmic Res) - "Even though patients' visual recovery does not benefit significantly, the FAc implant addresses the important pillars of chronic DME therapy regarding reduced injection frequency and reduced DME."

Journal • Diabetic Macular Edema • Ophthalmology

Real-World Outcomes of the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema. (PubMed, J Vitreoretin Dis) - "Implant migration to the anterior chamber occurred in 3 eyes, 2 of which were vitrectomized and later required removal. The 0.19 mg fluocinolone acetonide intravitreal implant provided long-term stabilization of VA and macular anatomy in patients with DME, despite a significant reduction in treatment frequency."

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

Open Label Trial Studying the Safety and Effectiveness of ILUVIEN® (190μg) in Children and Adolescents, Who Have Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye. (clinicaltrials.gov) - P4 | N=25 | Recruiting | Sponsor: Alimera Sciences

New P4 trial • Ocular Inflammation • Ophthalmology • Pediatrics • Uveitis

Real-World Experience of Fluocinolone Acetonide 0.19 mg in the Management of Non-Infectious Uveitis. (PubMed, Ocul Immunol Inflamm) - "A retrospective, observational study was conducted at Moorfields Eye Hospital, London, involving patients who received FAc 0.19 mg implants (Iluvien®) for NIU...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."

Journal • Real-world • Real-world evidence • Cataract • Inflammation • Macular Edema • Ocular Infections • Ocular Inflammation • Ophthalmology • Uveitis

Efficacy and Safety of 0.19-mg Fluocinolone Acetonide Implant in Postoperative Cystoid Macular Edema after Pars Plana Vitrectomy: the ILUCYD study. (PubMed, Ophthalmol Retina) - "FAc 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."

Journal • Macular Edema • Ophthalmology

The effectiveness of the 0.19 mg fluocinolone acetonide implant in treating non-infectious posterior uveitis: a real-world experience. (PubMed, J Ophthalmic Inflamm Infect) - "Our results suggest improvements and long-term maintenance in functional and anatomical outcomes with FAc implant with a manageable safety profile in a real-world clinical setting in patients with NIU-PS."

Journal • Real-world • Real-world evidence • Ocular Inflammation • Ophthalmology • Uveitis

Fluocinolone acetonide 0.2 µg/day intravitreal implant in non-infectious uveitis affecting the posterior segment: EU expert user panel consensus-based clinical recommendations. (PubMed, J Ophthalmic Inflamm Infect) - "As more clinical experience has been gained using FAc implants, it was necessary to update the clinical recommendations that guide patient management in the clinic. The current consensus document addresses relevant issues related to the use of FAc implants on different types of patients with various etiologies of NIU-PS, and was conducted to standardize approaches to help specialists obtain better clinical outcomes."

Journal • Review • Inflammation • Ocular Inflammation • Ophthalmology • Uveitis

Fluocinolone Acetonide Implant for Uveitis: Dissecting Responder and Non-Responder Outcomes at a Tertiary Center. (PubMed, Biomedicines) - "This study evaluated the efficacy of a fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN®) in treating non-infectious uveitis using real-world data...Eyes with a previous PPV showed milder results. Data showed a correlation between older age, a damaged ELM and IS/OS zone, frequent DEX inserts, and poorer outcome measures."

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