Posters

Efficacy and safety of once-daily nepafenac ophthalmic suspension 0.3% for improvement of clinical outcomes following cataract surgery in patients with diabetes

Poster Details

First Author: A. Tsorbatzoglou HUNGARY

Co Author(s):    A. Pollack   S. Modi   M. Guarro   A. Adewale   R. Singh        

Abstract Details

Purpose:

Nepafenac (0.3% once-daily or 0.1% thrice-daily) is a nonsteroidal anti-inflammatory drug, approved to treat pain and inflammation post cataract surgery. Nepafenac 0.1% is approved in Europe for reduction in risk of postoperative macular oedema (MO) in diabetic patients undergoing cataract surgery. Two similarly designed phase 3 studies were conducted to assess the efficacy and safety of nepafenac 0.3% for improvement in clinical outcomes following cataract surgery in diabetic patients. The primary results of these studies are reported previously. Here, we are reporting the outcomes of the additional secondary and supportive endpoints.

Setting:

Two prospective, randomised, phase 3, multicentre, double-masked, vehicle-controlled, parallel-group studies were conducted in diabetic patients with non-proliferative diabetic retinopathy (NPDR) requiring cataract extraction with planned implantation of posterior chamber intraocular lens. Study-1 (NCT01853072) was conducted in 66 centres (USA/Latin America/Caribbean) and Study-2 (NCT01872611) in 73 centres (USA/Europe/Middle East/Africa/Latin America/Caribbean/Asia Pacific).

Methods:

Adult patients with diabetes and NPDR were randomised (1:1) to topical nepafenac 0.3% or vehicle once-daily in the study eye starting a day before surgery and continuing for 90 days postoperatively. Additional secondary endpoints included the proportion of patients with a BCVA improvement of ≥15 letters from the preoperative baseline to Day 60 and to Day 90; proportion of patients with BCVA loss of >5, >10 letters from Day 7 to any visit. Supportive endpoints included proportion of patients with treatment failure, mean changes from baseline in CSMT, macular volume, and BCVA.

Results:

Greater proportion of patients showed a BCVA improvement of ≥15 letters from preoperative baseline to Day-60 with nepafenac versus vehicle (Study-1: 76.2% versus 64.7%, p=0.002; Study-2: 68.9% versus 62.1%, p=0.092; Pooled: 72.6% versus 63.4%, p<0.001) and to Day-90 (Study-1: 77.2% versus 67.7%, p=0.009; Study-2: 65.4% versus 65.9%, p=0.888; Pooled: 71.4% versus 66.8%, p=0.088; respectively). Fewer patients in nepafenac versus vehicle lost >5 (Study-1/Study-2/Pooled: p<0.001/p=0.540/p=0.029) and >10 letters (Study-1/Study-2/Pooled: p=0.020/p=0.458/p=0.211) from Day 7 to any visit in Study-1 and pooled analyses. In both studies, there were fewer treatment failures in the nepafenac group compared to vehicle. Across all supportive endpoints, differences in favour of nepafenac relative to vehicle were observed.

Conclusions:

Overall, nepafenac 0.3% showed better visual and optical coherence tomography (OCT) based outcomes relative to vehicle in the additional secondary and supportive endpoints. The totality of results from these studies demonstrate the clinical benefits of nepafenac 0.3%, given once daily, over vehicle for faster improvement and maintenance of visual acuity following cataract surgery in patients with diabetic retinopathy. Safety results that have been previously reported were consistent with the established safety profile of nepafenac.

Financial Disclosure:

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