NDAINTRAVITREALIMPLANTPriority Review
Approved
Sep 2014
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ILUVIEN (fluocinolone acetonide) by Eurofarma Laboratórios is corticosteroid hormone receptor agonists [moa]. First approved in 2014.
Drug data last refreshed 5h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ILUVIEN is a sustained-release intravitreal implant containing fluocinolone acetonide, a corticosteroid that reduces intraocular inflammation. It is indicated for the treatment of diabetic macular edema (DME) and other posterior segment inflammatory conditions affecting vision. The implant provides long-acting anti-inflammatory effects by suppressing corticosteroid hormone receptor pathways within the eye.
LOE Approaching2.1 years to LOE
Product is nearing loss of exclusivity (2028), signaling potential team restructuring and transition from growth-focused to defensive commercial strategies.
Mechanism of Action
Corticosteroid Hormone Receptor Agonists
Pharmacologic Class:
Corticosteroid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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.
Started Aug 2024
25 enrolled
Non-infectious Uveitis Affecting the Posterior Segment of the Eye
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
Started Nov 2023
600 enrolled
Radiation RetinopathyVisual Impairment
Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis
Started Jun 2022
125 enrolled
Uveitis, Posterior
A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
Started Aug 2020
300 enrolled
Diabetic Macular Edema
Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
Started Jul 2017
3 enrolled
Uveitis, Posterior
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.