Nevanac®
Nepafenac 0.1% · ophthalmic suspension
NSAID
Approved uses
Pain and inflammation associated with cataract surgery
One drop TID beginning 1 day before surgery, on the day of surgery, and through the first 2 weeks postoperatively.
Cells and flare clear completely by day 14 in 63%, and over 80% are pain free at every visit.
OFF-LABELNot in the FDA label for this product
Prevention of macular edema after cataract surgery in diabetic retinopathy (off-label)
Trial regimen: one drop TID beginning 1 day before surgery and continued through day 90, on top of tobramycin-dexamethasone QID for the first 2 weeks. Exceeds the labeled 14-day postoperative duration.
RCT · n=175 · acuity gain NS
Randomized, double-masked, vehicle-controlled multicenter trial in 175 patients with nonproliferative diabetic retinopathy: macular edema, defined as a 30% or greater rise in central subfield thickness, within 90 days of surgery in 5.0% (95% CI 1.4 to 12.3) versus 17.5% on vehicle (95% CI 9.9 to 27.6), p=0.01. The day 90 mean BCVA gain favored nepafenac but was not statistically significant (17.7 versus 14.3 letters, p=0.14).
Ocular pain after photorefractive keratectomy (off-label)
Trial regimen: one drop TID in the treated eye through postoperative day 2.
RCT · n=35 · no untreated arm
Contralateral-eye randomized comparative study in 35 patients, 0.1% TID in one eye versus nepafenac 0.3% once daily in the fellow eye through day 2, found no difference in pain scores, subepithelial haze, or visual acuity. There was no untreated or vehicle arm, so this establishes equivalence between the two concentrations, not efficacy over no treatment.
Contraindications
Hypersensitivity to any ingredient in the formulation or to other NSAIDs.
Available Forms0.1% sterile ophthalmic suspension, 3 mL in a 4 mL bottle
Mechanism of ActionNonsteroidal anti-inflammatory prodrug; penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, which inhibits prostaglandin H synthase (cyclooxygenase). Conversion occurs after corneal penetration, so prostaglandin blockade is generated within ocular tissue.
Warnings & Precautions
- Corneal effects: Topical NSAIDs may cause keratitis, and continued use in susceptible patients may progress to epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation, collectively the topical NSAID corneal melt spectrum. These events may be sight threatening; discontinue immediately on evidence of corneal epithelial breakdown and monitor corneal health closely.
- Higher-risk corneas: Complicated ocular surgery, repeat ocular surgery within a short period, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease such as dry eye, and rheumatoid arthritis raise the risk of sight-threatening corneal events in postmarketing reports.
- Extended perioperative use: Postmarketing reports with topical NSAIDs suggest that use more than 1 day before surgery, or beyond 14 days after surgery, may increase the risk and severity of corneal adverse events.
- Delayed healing: Topical NSAIDs may slow or delay healing, and concomitant topical corticosteroids, which also delay healing, may increase the potential for healing problems.
- Increased bleeding time: Potential for interference with thrombocyte aggregation; ocularly applied NSAIDs have been reported to increase bleeding of ocular tissues, including hyphema, in conjunction with ocular surgery. Use caution with known bleeding tendencies or concomitant drugs that prolong bleeding time.
- Contact lens wear: Not to be administered while contact lenses are worn.
- Contamination risk: Dropper tip contact with the eye or adnexa can contaminate the suspension and cause serious ocular infection and vision loss; a separate bottle per eye is preferred for surgical use.
Common Side Effects
- Ocular, 5% to 10%: Capsular opacity, decreased visual acuity, foreign body sensation, increased IOP, sticky sensation.
- Ocular, 1% to 5%: Conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing, vitreous detachment. Some of these may be consequences of the cataract procedure itself.
- Systemic, 1% to 4%: Headache, hypertension, nausea and vomiting, sinusitis.
Pregnancy & LactationPregnancy: Category C. No teratogenicity in rats or rabbits at oral doses up to 10 mg/kg/day, although maternally toxic doses in rats produced dystocia, increased post-implantation loss, reduced fetal weight and growth, and reduced fetal survival; avoid in late pregnancy because prostaglandin synthesis inhibitors can close the fetal ductus arteriosus.
Lactation: Excreted in the milk of lactating rats; human milk excretion unknown, so use caution in a nursing woman.
Pediatric UseSafety and effectiveness not established below age 10.