Nepafenac 0.3% after Cataract Surgery in Patients with Diabetic Retinopathy: Results of 2 Randomized Phase 3 Studies.

Abstract

PURPOSE:

To demonstrate the efficacy and safety of once-daily nepafenac 0.3% ophthalmic suspension versus vehicle, based on clinical outcomes, after cataract surgery in patients with diabetes.

DESIGN:

Two prospective, randomized, multicenter, double-masked, vehicle-controlled phase 3 studies.

PARTICIPANTS:

Total, 615 patients in study 1 and 605 patients in study 2.

METHODS:

Patients were randomized (1:1) to topical nepafenac 0.3% or vehicle once-daily starting the day before surgery and continuing for 90 days thereafter.

MAIN OUTCOME MEASURES:

Key efficacy variables were: patients (%) in whom macular edema (ME) developed (≥30% increase from preoperative baseline central subfield macular thickness) within 90 days after cataract surgery and the patients (%) with a best-corrected visual acuity (BCVA) improvement of ≥15 letters from preoperative baseline through day 14 maintained through day 90. Secondary end points included: patients (%) with a BCVA improvement of ≥15 letters from preoperative baseline through days 90 and 60 and safety over 3 months.

RESULTS:

A significantly lower percentage of patients demonstrated ME within 90 days after surgery with nepafenac 0.3% versus vehicle (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). The percentage of patients achieving a ≥15-letter improvement from baseline through day 14 maintained through day 90 with nepafenac 0.3% versus vehicle was 61.7% versus 43.0% (P < 0.001) in study 1, 48.8% versus 50.5% (P = 0.671) in study 2, and 55.4% versus 46.7% (P = 0.003) in the pooled analysis. A greater percentage of patients treated with nepafenac 0.3% versus vehicle in study 1 and similar percentage in study 2 had a BCVA improvement of ≥15 letters from preoperative baseline through day 90 (77.2% vs. 67.7% [P = 0.009] and 65.4% vs. 65.9% [P = 0.888]) and through day 60 (76.2% vs. 64.7% [P = 0.002] and 68.9% vs. 62.1% [P = 0.092]). No unanticipated adverse events were observed.

CONCLUSIONS:

These studies demonstrated the clinical benefits of nepafenac 0.3% over vehicle in reducing the risk of postoperative ME, with the integrated analysis showing improved BCVA after cataract surgery in patients with diabetic retinopathy, with no unanticipated safety events.

• Authors: Rishi P Singh, Robert Lehmann, Joseph Martel, Kevin Jong, Ayala Pollack, Alexis Tsorbatzoglou, Giovanni Staurenghi, Guadalupe Cervantes-Coste Cervantes, Louis Alpern, Satish Modi, Liza Svoboda, Adeniyi Adewale, Glenn J Jaffe
• Journal: Ophthalmology (Ophthalmology) Vol. 124 Issue 6 Pg. 776-785 (06 2017) ISSN: 1549-4713 [Electronic] United States
• PMID: 28268098 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Benzeneacetamides
• Ophthalmic Solutions
• Phenylacetates
• nepafenac

Topics

• Administration, Topical
• Aged
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects)
• Benzeneacetamides (administration & dosage, adverse effects)
• Cataract (etiology)
• Diabetic Retinopathy (complications)
• Double-Blind Method
• Female
• Humans
• Lens Implantation, Intraocular
• Macular Edema (etiology, prevention & control)
• Male
• Middle Aged
• Ophthalmic Solutions
• Phacoemulsification
• Phenylacetates (administration & dosage, adverse effects)
• Postoperative Care
• Prospective Studies
• Tomography, Optical Coherence
• Treatment Outcome
• Visual Acuity