title: Nepafenac 0.3% after Cataract Surgery in Patients with Diabetic Retinopathy: Results of 2 Randomized Phase 3 Studies.
abstract: 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.
  
  
  
  Two prospective, randomized, multicenter, double-masked, vehicle-controlled phase 3 studies.
  
  
  
  Total, 615 patients in study 1 and 605 patients in study 2.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.affiliation: Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: singhr@ccf.org.
authors.forename: Rishi P
authors.initials: RP
authors.lastname: Singh
authors.affiliation: Lehmann Eye Center, Nacogdoches, Texas.
authors.forename: Robert
authors.initials: R
authors.lastname: Lehmann
authors.affiliation: Martel Eye Medical Group, Rancho Cordova, California.
authors.forename: Joseph
authors.initials: J
authors.lastname: Martel
authors.affiliation: Houston Eye Associates, Houston, Texas.
authors.forename: Kevin
authors.initials: K
authors.lastname: Jong
authors.affiliation: Department of Ophthalmology, Kaplan Medical Center, Rehovot, Israel.
authors.forename: Ayala
authors.initials: A
authors.lastname: Pollack
authors.affiliation: Department of Ophthalmology, Szabolcs-Szatmár-Bereg County Hospital, Nyíregyháza, Hungary.
authors.forename: Alexis
authors.initials: A
authors.lastname: Tsorbatzoglou
authors.affiliation: Department of Biomedical and Clinical Science Luigi Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Staurenghi
authors.affiliation: Asociación Para Evitar la Ceguera en México, Hospital Dr. Luis Sánchez Bulnes, Mexico City, Mexico.
authors.forename: Guadalupe
authors.initials: G
authors.lastname: Cervantes-Coste Cervantes
authors.affiliation: Cataract, Glaucoma and Refractive Surgery Center, El Paso, Texas.
authors.forename: Louis
authors.initials: L
authors.lastname: Alpern
authors.affiliation: Poughkeepsie, New York.
authors.forename: Satish
authors.initials: S
authors.lastname: Modi
authors.affiliation: Alcon Research, Ltd., Lake Forest, California.
authors.forename: Liza
authors.initials: L
authors.lastname: Svoboda
authors.affiliation: Alcon Research, Ltd., Fort Worth, Texas.
authors.forename: Adeniyi
authors.initials: A
authors.lastname: Adewale
authors.affiliation: Department of Ophthalmology, Duke University, Durham, North Carolina.
authors.forename: Glenn J
authors.initials: GJ
authors.lastname: Jaffe
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D044482:Benzeneacetamides / Q000008:administration & dosage* / Q000009:adverse effects; D002386:Cataract / Q000209:etiology; D003930:Diabetic Retinopathy / Q000150:complications*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019654:Lens Implantation, Intraocular; D008269:Macular Edema / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D018918:Phacoemulsification; D010648:Phenylacetates / Q000008:administration & dosage* / Q000009:adverse effects; D011182:Postoperative Care; D011446:Prospective Studies; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D044482:Benzeneacetamides; D009883:Ophthalmic Solutions; D010648:Phenylacetates; C414203:nepafenac