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

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

Fluocinolone intravitreal implant (Iluvien) for macular edema secondary to immune recovery uveitis in patient with acute myeloid leukemia. (PubMed, J Ophthalmic Inflamm Infect) - "The Fluocinolone intravitreal implant may be an effective treatment for persistent CME in patients with immune recovery uveitis syndrome."

Journal • Acute Myelogenous Leukemia • Cytomegalovirus Infection • Genetic Disorders • Hematological Malignancies • Leukemia • Macular Edema • Ocular Inflammation • Oncology • Ophthalmology • Retinal Disorders • Uveitis

Efficacy and Safety of Fluocinolone Acetonide Implant (Iluvien®) in Postoperative Cystoid Macular Edema: ILUCYD study (ARVO 2024) - "Eyes with chronic PCME after cataract or either multiple or single vitreoretinal surgeries, previously treated with multiple injections of intravitreal dexamethasone (DEX) implant (Ozurdex®), and then treated with FAc-implant were included. FAc implant in eyes with chronic PCME showed lasting anatomic and functional improvement with a good safety profile. Final BCVA was correlated with intact outer retinal layers on SD-OCT. Furthermore, FAc implant allowed reduction of the treatment burden over 12 months."

Clinical • Cataract • Macular Edema • Ophthalmology

Efficacity and Safety of the Fluocinolone Acetonide Implant in Uveitic Macular Edema: A Real-Life Study from the French Uveitis Network. (PubMed, J Pers Med) - "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."

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

INTRAVITREAL STEROIDS AND DISORGANISATION OF RETINAL INNER LAYERS (DRIL) IN DIABETIC MACULAR OEDEMA: FINDINGS FROM A REAL-WORLD SINGLE-CENTRE COHORT (COPHy EU 2024) - "We evaluated whether intravitreal Ozurdex and Iluvien affected the presence of DRIL, and whether this correlated with changes to CRT. Thus, intravitreal steroids may treat DMO with DRIL better than anti-VEGF agents and should be considered in eyes responding inadequately to anti-VEGF agents or in DRIL-positive treatment-naïve eyes with DMO. Funding declaration: Yes; funding was provided by Allergan."

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

The UK National Institute for Health and Care Excellence (NICE) Issues Final Draft Guidance to Provide Patients with a Natural Lens (Phakic Eye) Being Treated for Chronic Diabetic Macular Edema Access to ILUVIEN (GlobeNewswire) - "Alimera Sciences, Inc...announces that the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending that patients with a natural lens (phakic patients) being treated for chronic diabetic macular edema (DME) have access to ILUVIEN 190 microgram intravitreal implant in applicator (fluocinolone acetonide)...NICE is recommending on label access to ILUVIEN as an option for treating visual impairment caused by chronic DME in phakic eyes. The Final Guidance for ILUVIEN in phakic eyes will be issued after February 22, 2024, when it will be combined with the previous NICE recommendation for patients with a pseudophakic lens and re-issued as a single updated guidance from NICE....NHS England has agreed with the Integrated Care Boards (ICB’s) to provide funding to implement this guidance 30 days after publication. NHS Wales will usually fund within 2 months of the final draft guidance."

NICE • Diabetic Macular Edema • Macular Edema • Ophthalmology • Retinal Disorders

Ocular, Visual, and Anatomical Outcomes in Eyes Requiring Incisional Intraocular Pressure-Lowering Surgery Following the 0.19-mg Fluocinolone Acetonide Intravitreal Implant. (PubMed, Ophthalmic Surg Lasers Imaging Retina) - "To assess ocular, visual, and anatomical outcomes following the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN®) and incisional intraocular pressure (IOP)-lowering surgery in diabetic macular edema...Post-FAc IOP-lowering surgery, regardless of cause, largely did not affect the outcomes measured; these procedures, then, may not meaningfully threaten positive outcomes. [Ophthalmic Surg Lasers Imaging Retina 2024;55:22-29.]."

Journal • Surgery • Diabetic Macular Edema • Glaucoma • Ophthalmology

ILUVIEN in diabetic macular edema that persists or recurs despite treatment: Results from the Retina.pt RIVER audit. (PubMed, Eur J Ophthalmol) - "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."

Journal • Diabetic Macular Edema • Ophthalmology

Long-Term Control of Retinal Thickness Variability and Vision Following the 0.19 mg Fluocinolone Acetonide Implant. (PubMed, J Vitreoretin Dis) - "Purpose: To assess the impact of retinal thickness variability (RTV) control on visual and treatment burden outcomes in patients with diabetic macular edema (DME) who received the 0.19 mg fluocinolone acetonide (FAc) intravitreal implant (Iluvien, Alimera Sciences)...A multivariate linear regression with baseline BCVA as a covariate displayed improved correlations with the last-observed BCVA, CST-AUC (R = -0.448), RTA (R = -0.432), and RTSD (R = -0.436). The sustained corticosteroid release of the 0.19 mg FAc implant reduced RTV in patients with DME, which directly correlated with significantly improved vision and a reduced supplemental treatment burden."

Journal • Diabetic Macular Edema • Ophthalmology

Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN®) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 months. (PubMed, Int Ophthalmol) - "The FAc implant is safe and effective at treating NIU over 12 months in a real-world setting in Spain."

Journal • Real-world • Real-world effectiveness • Real-world evidence • Cardiovascular • Glaucoma • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

0.19-mg fluocinolone acetonide intravitreal implant for diabetic macular edema: intraocular pressure-related effects over 36 months. (PubMed, Ophthalmol Retina) - "Over 36 months, the 0.19-mg FAc implant was associated with relatively stable IOPs in patients with DME, and there was no significant impact of IOP elevations identified regarding their effects on long-term visual outcomes. The probability that a prior corticosteroid challenge will not predict an IOP elevation >25 mmHg over 36 months post-FAc is 22%; therefore, routine IOP monitoring should be scheduled."

Journal • Diabetic Macular Edema • Ophthalmology

Retinal changes after fluocinolone acetonide implant (ILUVIEN®) for DME: SD-OCT imaging assessment using ESASO classification. (PubMed, Eur J Ophthalmol) - "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."

Journal • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders