Nepafenac 0.3% lowers risk of ME after cataract surgery

Stephen Padilla
23 May 2017
Nepafenac 0.3% lowers risk of ME after cataract surgery
Remind customers to use eye treatments for a month only, as, after that, they become ineffective

Two studies have shown the clinical benefits of once-daily nepafenac 0.3% in reducing the risk of postoperative macular oedema (ME). In addition, the integrated analysis shows improved best-corrected visual acuity (BCVA) after cataract surgery in patients with diabetic retinopathy, with no unanticipated safety events.

Researchers conducted two prospective, randomized, multicentre, double-masked, vehicle-controlled phase III studies to assess the efficacy and safety of once-daily nepafenac 0.3% ophthalmic suspension vs vehicle after cataract surgery in diabetic patients.

Patients (n=615 in study 1; n=605 in study 2) were randomly assigned 1:1 to topical nepafenac 0.3% or vehicle once-daily starting the day before surgery and continuing for 90 days thereafter. Key efficacy variables were patients (%) in whom ME developed (≥30-percent increase from preoperative baseline central subfield macular thickness) within 90 days after cataract surgery and those with a BCVA improvement of ≥15 letters from preoperative baseline through day 14 maintained through day 90.

The incidence of ME within 90 days postsurgery was significantly lower in patients who received nepafenac 0.3% compared to those who received vehicle (study 1: 2.3 vs 17.3 percent; p<0.001; study 2: 5.9 vs 14.3 percent; p=0.001; pooled analysis: 4.1 vs 15.9 percent; p<0.001). [Ophthalmology 2017;124:776–785]

There was a higher percentage of patients achieving a ≥15-letter improvement from baseline through day 14 maintained through day 90 with nepafenac 0.3% than with vehicle in study 1 (61.7 vs 43.0 percent; p<0.001) and similar percentage in study 2 (48.8 vs 50.5 percent; p=0.671; pooled analysis: 55.4 vs 46.7 percent; p=0.003).

“The [two] randomized, vehicle-controlled phase III studies demonstrated that nepafenac 0.3%, when given once-daily beginning 1 day before surgery and continued for 90 days, was superior to vehicle in reducing the risk of ME after cataract surgery in patients with diabetes,” researchers said.

The percentage of patients who had a BCVA improvement of ≥15 letters was greater with nepafenac 0.3% vs vehicle in study 1 and similar in study 2 from preoperative baseline through day 90 (study 1: 77.2 vs 67.7 percent; p=0.009; study 2: 65.4 vs 65.9 percent; p=0.888) and through day 60 (study 1: 76.2 vs 64.7 percent; p=0.002; study 2: 68.9 vs 62.1 percent; p=0.092).

“In study 1, clinically relevant differences between nepafenac 0.3% and vehicle were observed for all the BCVA endpoints, whereas in study 2, the outcomes were similar between the nepafenac 0.3% and vehicle groups,” researchers said. “The BCVA outcomes in the pooled analysis were similar to the results observed in study 1.”

There were no unanticipated adverse events observed in the studies.

“Macular oedema remains a common cause of suboptimal vision after cataract surgery,” researchers said. “Patients with diabetes have an increased risk of experiencing postsurgical complications and associated poor visual outcomes after cataract surgery. Thus, it is important to monitor macular changes in patients with diabetes after cataract surgery.” [Ophthalmology 2007;114:881–889]

Nepafenac 0.3%, dosed once-daily beginning the day prior to surgery and continued 90 days thereafter, had a comparable overall safety profile with that of nepafenac 0.1% dosed thrice-daily for the same duration in patients with diabetic retinopathy, according to researchers.

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