What is the indication for Nevanex (nepafenac) eye drops?

Nevanex (Nepafenac) Eye Drop Indications

Nevanex is FDA-approved for treating pain and inflammation associated with cataract surgery, and in Europe, it is additionally approved for reducing the risk of postoperative macular edema in diabetic patients undergoing cataract surgery. 1, 2

Primary FDA-Approved Indication

Prevention and treatment of postoperative ocular pain and inflammation following cataract surgery is the core indication for nepafenac ophthalmic suspension in the United States. 1, 3, 2

• The 0.1% formulation (Nevanac) is dosed three times daily, while the 0.3% formulation (Ilevro) offers once-daily dosing with comparable efficacy 2
• Treatment typically begins 1 day before surgery and continues for 14 days postoperatively 3, 2
• An additional drop should be administered 30-120 minutes prior to surgery 3, 2

European Extended Indication

In Europe, nepafenac carries an additional indication for reducing the risk of postoperative macular edema associated with cataract surgery specifically in diabetic patients. 4

• This indication is supported by nepafenac's ability to reach pharmacologically relevant concentrations in the posterior segment (choroid and retina) via local distribution through the sclera 4
• Peak concentrations in posterior retina reach 2.72-13.8 nM following topical administration, with sustained high concentrations in posterior tissues serving as a reservoir for conversion to the active metabolite amfenac 4

Off-Label Use in Refractive Surgery

Nepafenac has demonstrated efficacy for pain control and promoting corneal re-epithelialization following photorefractive keratectomy (PRK), though this is not an FDA-approved indication. 5

• Mean time to re-epithelialization was 5.50 days with nepafenac 0.1%, significantly faster than bromfenac 0.09% (7.25 days, P<0.05) 5
• Pain relief was achieved by postoperative day 1 with nepafenac, earlier than other NSAIDs 5

Role in Perioperative Cataract Care

The American Academy of Ophthalmology recommends topical NSAIDs within the first post-surgical month as part of comprehensive postoperative management, particularly when combined with preservative-free formulations to minimize ocular surface irritation in high-risk patients. 6, 7

• Postoperative follow-up should occur on day 1, during weeks 1-2, and at 1 month to evaluate treatment effect 7
• NSAIDs should be used alongside topical steroids and preservative-free artificial tears for optimal outcomes 6, 7

Important Contraindications

Nepafenac is NOT indicated as monotherapy for bacterial keratitis or other infectious conditions. 1

• The drug provides no antimicrobial coverage and should never replace appropriate antibiotic therapy for corneal ulcers or keratitis 6
• When infection risk exists alongside inflammation, combination products with antibiotics (like Tobradex) are more appropriate than nepafenac alone 8, 1