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Efficacy and safety of once-daily nepafenac ophthalmic suspension, 0.3% for the prevention and treatment of ocular pain and inflammation following cataract surgery

Session Details

Session Title: Cystoid Macular Oedema and Infection

Session Date/Time: Sunday 06/10/2013 | 16:30-18:00

Paper Time: 16:48

Venue: Forum (Ground Floor)

First Author: : A.Tsorbatzoglou HUNGARY

Co Author(s): :    D. Sager   S. Modi           

Abstract Details

Purpose:

To assess the efficacy and safety of once-daily nepafenac 0.3% for the prevention and treatment of ocular pain and inflammation in patients undergoing cataract surgery.

Setting:

Sixty-five centers in Europe and the United States.

Methods:

This was a parallel-group, double-masked, vehicle- and active-controlled, Phase 3 study (NCT01109173). Patients were randomized (4:4:1:1) to receive once-daily nepafenac 0.3% (n=807), three-times daily [TID] nepafenac 0.1% (n=813), or their respective vehicles (n=197 and 205), beginning 1 day prior to surgery and continuing for 14 days after cataract extraction. An additional drop of nepafenac 0.3% was administered 30-120 minutes before surgery. The primary endpoint was the percentage of patients with cure for inflammation at Day 14, defined as a score of 0 for both aqueous cells and flare. Information on adverse events (AEs) was collected for all patients after the first administration of study drug on Day -1 and continued through Day 14 or exit from the study.

Results:

The majority of patients were 65 years of age and older (mean age, 68.9 years), female (57.2%), and White (86.8%). Significantly more nepafenac 0.3% patients had no inflammation (68.4% vs 34.0%; p<0.0001) and were pain-free (91.0% vs 49.7%; p<0.0001) at Day 14 versus vehicle. Nepafenac 0.3% was noninferior to nepafenac 0.1% for the percentage of patients cured of inflammation (95% confidence interval [CI]: 5.73%, 3.17%) and for patients who were pain-free (95% CI: 3.08%, 2.70%). At all postoperative visits, more patients treated with nepafenac 0.3% achieved clinical success (p?0.0264) and fewer were treatment failures (p?0.0012) compared with its vehicle. Nepafenac 0.3% was well tolerated. Treatment-emergent AEs occurred in 12.2% and 10.0% of patients receiving nepafenac 0.3% and nepafenac 0.1%, respectively, versus 19.4% and 16.1% for their vehicles.

Conclusions:

Nepafenac ophthalmic suspension administered once daily was superior to its vehicle and noninferior to nepafenac 0.1% TID for the prevention and treatment of ocular pain and inflammation following cataract surgery. Nepafenac 0.3% was well tolerated and has a safety profile comparable to that of nepafenac 0.1%, with the added convenience of once-daily dosing.

Financial Interest:

... is employed by a for-monetary company with an interest in the subject of the presentation, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented