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The safety and efficacy of once daily nepafenac 0.3% ophthalmic suspension for improved clinical outcomes in patients with diabetes following cataract surgery: rationale and design of two prospective, randomized phase 3 studies

Session Details

Session Title: Miscellaneous

Session Date/Time: Thursday 17/09/2015 | 11:00-12:30

Paper Time: 11:24

Venue: Athena.

First Author: : R.Singh UNITED STATES

Co Author(s): :    A. Adewale   A. Narvekar           

Abstract Details

PURPOSE:Nepafenac (0.3% QD or 0.1% TID) is a NSAID, approved to treat pain and inflammation post cataract surgery (CS). In animal studies, topically administered nepafenac, and its active metabolite, amfenac, reached pharmacologically relevant concentrations in the posterior eye segment. In clinical studies, compared to vehicle, nepafenac 0.1% significantly reduced macular edema (ME) occurrence rate and maintained vision in diabetic retinopathy patients following CS. Nepafenac 0.1% is approved in Europe for reduction in risk of postoperative ME in diabetics undergoing CS. The current studies will evaluate safety and efficacy of nepafenac 0.3% for extended use in diabetic retinopathy patients following CS.

Setting:

Two, randomized, multicenter, double-masked, vehicle-controlled, parallel-group, phase 3 studies. Study 1 (NCT01853072) is being conducted at study sites in the US and Latin America, and Study 2 (NCT01872611) at sites in 14 countries including the US, Europe, Latin America and Asia Pacific region.

Methods:

Adult diabetic retinopathy patients with non-proliferative retinopathy requiring cataract surgery were randomized 1:1 to receive either nepafenac 0.3% or vehicle. Dosing is once daily beginning one day prior to surgery and continued for 90 days postoperatively. All patients receive topical ocular steroid (prednisolone acetate or similar alternate) for 4 weeks postoperatively. The key efficacy variables are the proportion of patients with best-corrected visual acuity (BCVA) improvement of ≥15 letters from preoperative baseline to Day 14 and maintained through Day 90, and the proportion of patients who develop macular edema (≥30% increase from preoperative baseline in central subfield macular thickness) within 90 days following cataract surgery. Safety analysis is based on evaluation of adverse events and safety parameters.

Results:

Patient recruitment began in June 2013 and has been completed for both studies. 615 patients have been randomized in Study 1 at 57 sites (in the US, Dominican Republic, Panama, Mexico and Colombia) and 605 patients have been randomized in Study 2 at 58 sites (in the US, Austria, Italy, France, Hungary, Germany, Spain, Israel, Mexico, Peru, Colombia, Singapore, Philippines and Australia). The studies are expected to be completed in 2015.

Conclusions:

Diabetic patients have an increased risk for development of macular edema and associated visual impairment following cataract surgery. The results from the current Phase 3 studies will inform on the safety and efficacy of topical nepafenac 0.3% dosed once daily for 90 days after surgery and determine if treatment results in improved clinical outcomes in this at risk patient population.

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