Andrew Chang1 ,3, Jennifer Arnold4, Peter Davies5, Wilson Heriot6 ,7, Adeniyi Adewale8, Nandor Jaross9
Purpose: To evaluate the efficacy and safety of once-daily nepafenac 0.3% suspension relative to vehicle based upon clinical outcomes following cataract surgery (CS) in diabetic retinopathy (DR) patients.
Method: In two identically designed, Phase 3, multicentre, double-masked, vehicle-controlled studies, patients (Study-1: 615; Study-2: 605) were randomized 1:1 to receive nepafenac or vehicle, once-daily, one day before CS, on the day of CS and for 90 days thereafter. Key endpoints included patients (%) who developed macular oedema (ME) within 90 days post-CS; patients (%) with a ?15-letter best-corrected visual acuity (BCVA) improvement from preoperative baseline to Day-14, maintained through Day-90 and safety assessments.
Results: A significantly lower proportion of patients in nepafenac group than in vehicle group developed ME within 90 days post-CS (Study-1: 2.3% vs 17.3%, p<0.001; Study-2: 5.9% vs 14.3%, p=0.001; pooled: 4.1% vs 15.9%; p<0.001). Patients (%) with ?15-letter improvement in BCVA from baseline to Day-14, maintained to Day-90 were higher in the nepafenac group compared with vehicle in Study-1 (61.7% vs 43%, p<0.001) and pooled (55.4% vs 46.7%, p=0.003); and were similar between treatment groups in Study-2 (48.8% vs 50.5%, p=0.671). In both studies, <3% of patients reported treatment-related adverse events in the nepafenac and vehicle groups.
Conclusion: Once-daily nepafenac 0.3% was superior to vehicle in reducing the risk of postoperative ME in patients with DR. Results of Study-1 and pooled analyses support the clinical benefit of nepafenac 0.3% for faster improvement/maintenance of VA post-CS. No new safety signals were identified.