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Nevanac (NEPAFENAC)
Nevanac works by inhibiting the enzyme prostaglandin G/H synthase 2, which is involved in producing prostaglandins that cause pain and inflammation.
Nevanac (nepafenac) is a nonsteroidal anti-inflammatory drug (NSAID) developed by Alcon Pharmaceuticals Ltd, now owned by Harrow Eye. It targets prostaglandin G/H synthase 2 to reduce inflammation and pain. Nevanac is FDA-approved for post-operative ocular inflammation and pain, with an approval date of 2005. It remains a patented product with no generic manufacturers available. Key safety considerations include potential eye irritation and increased risk of corneal epithelial defects.
At a glance
| Generic name | NEPAFENAC |
|---|---|
| Sponsor | Harrow Health |
| Drug class | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Target | Prostaglandin G/H synthase 2 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2005 |
Mechanism of action
After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, nonsteroidal anti-inflammatory drug. Amfenac is thought to inhibit the action of prostaglandin synthase (cyclooxygenase), an enzyme required for prostaglandin production.
Approved indications
- Post-Op Ocular Inflammation
- Postoperative Ocular Pain
Common side effects
- capsular opacity
- decreased visual acuity
- foreign body sensation
- increased intraocular pressure (IOP)
- sticky sensation
- conjunctival edema
- corneal edema
- dry eye
- lid margin crusting
- ocular discomfort
- ocular hyperemia
- ocular pain
Key clinical trials
- A Comparative Analysis of the Effectiveness of Nepafenac Combined With a Lubricant Versus a Lubricant Alone in the Treatment of Epiphora Associated With Lacrimal Punctum Stenosis (PHASE4)
- The TRIBECA Study (TRIessence/Byqlovi for Easier CAtaract Surgery) (PHASE4)
- Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery (NA)
- Effects of 0.1% Nepafenac on Vitreous Inflammatory Biomarkers in Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy (PHASE4)
- NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME) (PHASE2)
- Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation (PHASE2)
- Eplerenone, Aflibercept and Topical Nepafenac Serous Foveal Deta Chment in Central Serous Chorioretinopathy
- DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC) (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9662398 | 2030-12-01 | Formulation |
| 8921337 | 2032-03-31 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nevanac CI brief — competitive landscape report
- Nevanac updates RSS · CI watch RSS
- Harrow Health portfolio CI