ILEVRO (nepafenac)
ILEVRO is indicated for the treatment of Pain; Inflammation.
How ILEVRO Works
Nepafenac is a prodrug that, upon topical ocular administration, penetrates the cornea and is converted by ocular tissue hydrolases into amfenac, an active NSAID. Amfenac inhibits the action of prostaglandin H synthase (cyclooxygenase), the enzyme required for the biosynthesis of prostaglandins. By suppressing prostaglandin production, the drug effectively reduces ocular inflammation and associated pain.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-10-16
- Patent Cliff
- 2032
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
ILEVRO Approval History
What ILEVRO Treats
2 indicationsILEVRO is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
- Inflammation
ILEVRO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 ILEVRO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00801905 NEPAF | NEPAFENAC IN PRFC NEPAFENACO | Ph 2 | terminated | Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation |
| NCT01939691 MEND | 18-24978 | Ph 4 | terminated | Macular Edema Nepafenac vs. Difluprednate Uveitis Trial |
| NCT01310127 results posted | MAC-02-11 | Ph 4 | completed | Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1% |
| NCT03886779 | BLMAIIT-02-13 | Ph 4 | completed | Study Title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial |
| NCT02515045 results posted | CEP 14-002 | Ph 4 | completed | Dropless vs. Standard Drops Contralateral Eye Study |
| NCT00900887 | HJM 1470/08.03.18 | Ph 2 | completed | Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema |
| NCT02084576 | 2014.02 HOB03022014 | Ph 4 | completed | Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification |
| NCT01995890 | TVPEI | Ph 4 | completed | Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes |
| NCT01021761 results posted | 2009 0199 | Ph 4 | completed | A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification |
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.
ILEVRO FDA Label Details
Indications & Usage
FDA Label (PDF)ILEVRO is indicated for the treatment of Pain; Inflammation.
Pro Intelligence Preview
Deep insights for ILEVRO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 2 active patents
Trial Analysis
- • 9 total trials
- • Stage: Mature
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