NEVANAC (nepafenac)
Nevanac is a nonsteroidal anti-inflammatory medication used for patients undergoing cataract surgery. It helps manage the pain and inflammation that typically follow the procedure. This medication is applied topically to the eye to support patient comfort during the post-operative recovery period.
How NEVANAC Works
This medication works by penetrating the cornea, where ocular tissues convert it into amfenac, an active anti-inflammatory agent. Amfenac inhibits the cyclooxygenase enzyme, which is required for the body to produce prostaglandins. By blocking the production of these substances, the drug reduces the inflammatory response and pain in the eye.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2005-08-19
- Patent Cliff
- 2027
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
NEVANAC Approval History
What NEVANAC Treats
2 indicationsNEVANAC is approved for 2 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
- Inflammation
NEVANAC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 NEVANAC
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
11 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 |
| NCT01657266 results posted | SOPH155-0412/II | Ph 2 | completed | Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification |
| NCT03597867 | 02/2017 | Ph 3 | completed | PGE2 Levels in Patient Treated With NSAIDs |
| 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 |
| NCT00828477 | 2009-0144 | Ph 4 | completed | Evaluation of Comfort With Xibrom (Bromfenac Ophthalmic Solution)0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT) |
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.
NEVANAC FDA Label Details
Indications & Usage
FDA Label (PDF)NEVANAC is indicated for the treatment of Pain; Inflammation.
NEVANAC Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for NEVANAC
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 1 active patents
Trial Analysis
- • 3 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