May 2007
Volume 48, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2007
A Double-Masked, Randomized, Single-Dose, Pharmacokinetic Study of Nepafenac, Amfenac, Ketorolac, and Bromfenac in Human Aqueous Humor Following Topical Administration of NevanacTM, Acular LSTM, or XibromTM
Author Affiliations & Notes
  • T. R. Walters
    Keystone Research Ltd, Austin, Texas
  • M. Raizman
    Ophthalmic Consultants of Boston, Boston, Massachusetts
  • P. Ernest
    Blake Woods Medical Park Surgery Center, Jackson, Michigan
  • J. Gayton
    Eyesight Associates, Warner Robins, Georgia
  • R. Lehmann
    Lehmann Eye Center, Nacogdoches, Texas
  • Footnotes
    Commercial Relationships T.R. Walters, Alcon, R; M. Raizman, Alcon, C; P. Ernest, Alcon, R; J. Gayton, Alcon, R; R. Lehmann, Alcon, R.
  • Footnotes
    Support Alcon Laboratories, Inc.
Investigative Ophthalmology & Visual Science May 2007, Vol.48, 1060. doi:https://doi.org/
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      T. R. Walters, M. Raizman, P. Ernest, J. Gayton, R. Lehmann; A Double-Masked, Randomized, Single-Dose, Pharmacokinetic Study of Nepafenac, Amfenac, Ketorolac, and Bromfenac in Human Aqueous Humor Following Topical Administration of NevanacTM, Acular LSTM, or XibromTM. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1060. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose:: To evaluate the aqueous humor concentrations of nepafenac, amfenac, ketorolac, and bromfenac following topical administration of Nevanac, Acular LS, or Xibrom

Methods:: Patients who were at least 18 years of age, of any race and either gender, and requiring cataract extraction with planned IOL implantation were randomized to 1 of 3 treatments consisting of either 1 drop of Nevanac, Acular LS, or Xibrom prior to cataract surgery. Patients were administered the test article at 30, 60, 120, 180, or 240 minutes before cataract surgery. At the time of paracentesis, the aqueous humor sample was collected (approximately 0.15 mL) from the study eye. Each sample was analyzed for drug concentration and AUC0-4h was calculated for each drug.

Results:: Seventy-five patients participated in the study. Nepafenac had the fastest tmax (30 min), followed by ketorolac (60 min), amfenac (180 min), and bromfenac (240 min). Nepafenac had the highest Cmax (205.3 ± 101.7 ng/ml), followed by amfenac (70.1 ± 20.1 ng/ml), ketorolac (57.5 ± 38.8 ng/ml), and bromfenac (23.9 ± 3.9 ng/ml). The Cmax for nepafenac was significantly higher than that of all the other drugs (p<0.05); the Cmax for bromfenac was significantly lower than nepafenac (p=0.0162) and amfenac (p=0.0058), and similar to ketorolac (p=0.1250). The AUC for nepafenac (331.1 ng h/ml) was significantly higher (p<0.05) than the AUCs of amfenac, ketorolac, and bromfenac (178.1, 176.9, and 49.2 ng h/ml, respectively). The AUCs of amfenac and ketorolac were significantly higher than that of bromfenac (p<0.05). The combined AUCs of nepafenac and amfenac yielded the highest AUC compared to all products (487.5 ng h/ml, p<0.05).

Conclusions:: Nevanac demonstrated a significantly greater ocular bioavailability of drug than either Acular LS or Xibrom, suggesting that differences in efficacy may exist among these 3 agents for the prevention and treatment of anterior chamber inflammation following cataract surgery.

Clinical Trial:: www.clinicaltrials.gov pending

Keywords: cataract • inflammation • metabolism 
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