Nepafenac 0.3% After Cataract Surgery in Patients With Diabetic Retinopathy
Ophthalmology, June 2017
Singh et al. conducted 2 randomized phase 3 trials to determine the efficacy and safety of once-daily nepafenac 0.3% ophthalmic suspension in preventing postoperative macular edema after cataract surgery. They found that the treatment reduces the risk of postoperative macular edema and has a favorable safety profile, similar to that of nepafenac 0.1% dosed 3 times daily.
In these 2 multicenter, double-masked, vehicle-controlled studies, a total of 1,220 adults with diabetic retinopathy were randomized to receive topical nepafenac 0.3% or vehicle, once daily, starting the day before cataract surgery and continuing for 90 days thereafter. Key efficacy variables were the rate of macular edema based on OCT change within 90 days following surgery and the proportion of patients whose best-corrected visual acuity (BCVA) improved by at least 15 letters from preoperative baseline value through day 14 and was maintained through day 90. Secondary variables included safety through day 90 and BCVA improvement of ≥15 letters from baseline to days 60 and 90.
In both studies, the rate of macular edema within 90 days following surgery was significantly lower for patients who received nepafenac (study 1: 2.3% vs. 17.3% with vehicle; p < .001; study 2: 5.9% vs. 14.3% with vehicle; p = .001; pooled: 4.1% vs. 15.9% with vehicle; p < .001). In study 1, more patients who received nepafenac experienced BCVA improvement of at least 15 letters from baseline through day 14, and maintained it through day 90 (61.7% vs. 43.0% with vehicle; p < .001); in study 2, improvement rates were comparable for the 2 groups (48.8% vs. 50.5%, respectively; p = .671).
In both studies, secondary analyses showed greater efficacy for nepafenac versus vehicle at 60 and 90 days. No unanticipated adverse events were observed in either study. The incidence of treatment-emergent adverse events (TEAE) and of serious TEAEs was similar for the 2 study arms in both trials.
The original article can be found here.