ILUVIEN (fluocinolone acetonide)
ILUVIEN is indicated for the treatment of Diabetic Macular Edema; Uveitis.
How ILUVIEN Works
Fluocinolone acetonide inhibits inflammatory responses, including edema, fibrin deposition, capillary dilation, and leukocyte migration. It is thought to act by inducing inhibitory proteins called lipocortins, which inhibit phospholipase A2. This inhibition prevents the release of arachidonic acid, thereby suppressing the biosynthesis of potent inflammatory mediators such as prostaglandins and leukotrienes.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-09-26
- Patent Cliff
- 2028
- Routes
- INTRAVITREAL
- Dosage Forms
- IMPLANT
ILUVIEN Approval History
What ILUVIEN Treats
2 indicationsILUVIEN is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetic Macular Edema
- Uveitis
ILUVIEN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ILUVIEN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05844982 AL | Protocol AL UG1EY014231 | Ph 3 | recruiting | Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy |
| NCT01781936 Iluvien | Pro00033019 | Ph 1 | completed | Pilot Study of a Fluocinolone Acetonide Intravitreal Insert (FA-i) to Treat Intermediate-, Posterior-, or Panuveitis |
| NCT02359526 RESPOND | 4C-2014-06 | Ph 4 | completed | A Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients |
| NCT02472366 results posted | M-01-13-002 | Ph 4 | completed | A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy |
| NCT00695318 results posted | C-01-08-004 | Ph 2 | terminated | Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy |
| NCT00770770 FAVOR results posted | C-01-08-006 | Ph 2 | terminated | Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina |
| NCT01304706 results posted | C-01-11-008 | Ph 3 | completed | Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ILUVIEN FDA Label Details
Indications & Usage
FDA Label (PDF)ILUVIEN is indicated for the treatment of Diabetic Macular Edema; Uveitis.
Pro Intelligence Preview
Deep insights for ILUVIEN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 3 active patents
Trial Analysis
- • 10 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment