Efficacy of nepafenac ophthalmic suspension 0.1% in improving clinical outcomes following cataract surgery in patients with diabetes: an analysis of two randomized studies

Abstract

Objective

To assess the efficacy of nepafenac 0.1% ophthalmic suspension in improving the clinical outcomes following cataract surgery (CS) in patients with nonproliferative diabetic retinopathy.

Methods

In two similar multicenter, randomized studies, patients received either nepafenac 0.1% or vehicle, instilled three times daily starting a day prior to surgery and continuing for 90 days postoperatively. A post hoc analysis of these two studies was conducted to assess 1) the likelihood for development of postoperative macular edema (ME), based on the percentage of patients who developed ME (≥30% increase from preoperative baseline in central subfield macular thickness) within 90 days following CS and 2) best-corrected visual acuity (BCVA) endpoints, including the percentage of patients with a BCVA improvement of ≥15 letters from preoperative baseline to Day 14 and maintained through Day 90. Results for individual studies and their pooled estimates (only visual acuity endpoints) are reported. Primary inference was based on odds ratio (OR).

Results

This post hoc analysis included 411 patients (nepafenac 0.1%: 205; vehicle: 206). The incidence of postoperative ME within 90 days of CS was notably lower in the nepafenac-treated patients than in vehicle-treated patients (study 1: 3.2% vs 16.7%; OR =0.2, 95% confidence interval [CI] =0.1, 0.5, P=0.001; study 2: 5.0% vs 17.5%; OR =0.2, 95% CI =0.1, 0.8, P=0.018). A higher percentage of nepafenac-treated patients than vehicle-treated patients gained ≥15 letters from preoperative baseline to Day 14, which was maintained through Day 90 (study 1: 38.4% vs 21.4%; OR =2.4, 95% CI =1.4, 4.2, P=0.003; study 2: 35.0% vs 25.0%; OR =1.6, 95% CI =0.8, 3.2, P=0.172; pooled: 37.1% vs 22.8%; OR =2.0, 95% CI =1.3, 3.1, P=0.001). The odds of >5-letter and >10-letter loss in BCVA from postoperative Day 7 were higher in vehicle-treated than in nepafenac-treated patients.

Conclusion

These results support the clinical benefit of prophylactic use of nepafenac 0.1% for reducing the risk of postoperative ME and for improvement in BCVA outcomes following CS in patients with nonproliferative diabetic retinopathy.

Keywords:

• cataract surgery
• nonproliferative diabetic retinopathy
• nepafenac 0.1%
• postoperative macular edema
• visual outcomes

Acknowledgments

The study was funded by Alcon Research Ltd (now a Novartis company), Fort Worth, TX, USA. Medical writing support for this manuscript was provided by Shivani Vadapalli (Novartis Healthcare Pvt Ltd, Hyderabad, India).

Disclosure

Rishi P Singh is a consultant for Alcon, Regeneron, Genentech, Zeiss, and Shire and conducts sponsored research for Genentech/Roche, Regeneron, and Apellis. Giovanni Staurenghi reports personal fees from Novartis, personal fees from Alcon, personal fees from Bayer, personal fees from Allergan, personal fees from Boehringer Ingelheim, personal fees from Genentech, personal fees from Roche, grants and personal fees from Zeiss Meditec, grants and personal fees from Heidelberg Engineering, grants and personal fees from Optos, and grants and personal fees from Centervue outside the submitted work. Ayala Pollack has received research grant from Alcon, Bayer, Neovista, Novartis, Ophthotech, Regeneron, Quark, and Santen. Robert Lehmann is a consultant for Alcon and conducts sponsored research for Baush & Lomb, AMO, WaveTech, Omerous, and AVS. Adeniyi Adewale, Thomas Walker, and Dana Sager are employees of Alcon Research Ltd, Fort Worth, TX. The authors report no other conflicts of interest in this work.