Ocular pharmacokinetics of a single dose of bromfenac sodium ophthalmic solution 0.1% in human aqueous humor

Journal of Ocular Pharmacology and Therapeutics

Volumn 24, Issue 6, 2008, Pages 573-578

  Miyake, Kensaku ^a   Ogawa, Takahiro ^b   Tajika, Tetsuya ^c   Gow, James A ^d   McNamara, Timothy R ^d  

^a Miyake Eye Hospital   (Japan)

^b Senju USA Inc   (United States)

^c SENJU PHARMACEUTICAL CO LTD   (Japan)

^d ISTA Pharmaceuticals Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BROMFENAC; CYCLOOXYGENASE 2;

ADULT; AGED; ANTIINFLAMMATORY ACTIVITY; AQUEOUS HUMOR; ARTICLE; CATARACT EXTRACTION; CLINICAL TRIAL; COMPUTER MODEL; COMPUTER SIMULATION; CONCENTRATION RESPONSE; DRUG EFFICACY; EYE INFLAMMATION; EYE PAIN; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IC 50; LENS IMPLANT; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; PARACENTESIS; PHASE 2 CLINICAL TRIAL; POSTOPERATIVE PERIOD; PREMEDICATION; SINGLE DRUG DOSE; TREATMENT INDICATION;

ADULT; AGED; AGED, 80 AND OVER; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; AQUEOUS HUMOR; BENZOPHENONES; BROMOBENZENES; FEMALE; HUMANS; MALE; MIDDLE AGED;

EID: 57349135286     PISSN: 10807683     EISSN: None     Source Type: Journal    
DOI: 10.1089/jop.2007.0132     Document Type: Article

References (44)

1. Flach, A.J. Topical nonsteroidal anti-inflammatory drugs in ophthalmology. Int. Ophthalmol. Clin. 42:1-11, 2002.
2. O'Brien, T.P. Emerging guidelines for the use of NSAID therapy to optimize cataract surgery and patient care. Curr. Med. Res. Opin. 21:1131-1137, 2005.
3. McColgin, A.Z., and Heier, J.S. Control of intraocular inflammation associated with cataract surgery. Curr. Opin. Ophthalmol. 11:3-6, 2000.
4. Miyake, K. Prevention of cystoid macular edema after lens extraction by topical indomethacin (I): A preliminary report. Graefe's. Arch. Klin. Exp. Ophthal. 203:81-88, 1977.
5. Miyake, K., Sakamura, S., and Miura, H. Long-term follow-up study on prevention of aphakic cystoid macular oedema by topical indomethacin. Br. J. Ophthalmol. 64:324-328, 1980.
6. McColgin, A.Z., and Raizman, M.B. Efficacy of topical Voltaren in reducing the incidence of postoperative cystoid macular edema. Invest. Ophthalmol. Vis. Sci. 40:S289, 1999.
7. Heier, J.S., Topping, T.M., Baumann, W., et al. Ketorolac versus prednisolone versus combination therapy in the treatment of acute pseudophakic cystoid macular edema. Ophthalmology 107:2034-2038, 2000.
8. th Annual American Academy of Ophthalmology (AAO) Meeting, Las Vegas, NV, November 11-14, 2006.
9. Bakalyan, G.A., Deshmukh, H.M., Patterson, H., et al. Concentrations of radioactivity in ocular tissues after a single topical dose of 14C-bromfenac ophthalmic solution. P227. Proceedings for the 32nd Symposium on Cataract, IOL, and Refractive Surgery of the American Society of Cataract and Refractive Surgery (ASCRS) Meeting, San Francisco, CA, March 17-22, 2006.
10. 14C-bromfenac ophthalmic solution (Xibrom™). 5086/B484. Proceedings of the 78th Annual Meeting of The Association for Research in Vision and Ophthalmology (ARVO), Ft. Lauderdale, FL, April 30-May 4, 2006.
11. Helberg, M.R., and Nixon, J.C. Use of nonsteroidal anti-inflammatory agents in combination with compounds that have PF prostaglandin agonist activity to treat glaucoma and ocular hypertension. Alcon Laboratories, Inc., assignee. U.S. Patent 6,342,524 B1. January 29, 2002.
12. Waterbury, L.D., Silliman, D., and Jolas, T. Comparison of cyclo-oxygenase inhibitory activity and ocular anti-inflammatory effects of ketorolac tromethamine and bromfenac sodium. Curr. Med. Res. Opin. 22:1133-1140, 2006.
13. Yanni, J.M., Graff, G., and Hellberg, M.R. Topically administrable compositions containing 3-benzoylphenylacetic acid derivatives for treatment of ophthalmic inflammatory disorders. Alcon Laboratories, Inc., assignee. U.S. Patent 5,475,034. December 12, 1995.
14. Amico, L.M., Bucci, F.A., and Waterbury, L.D. Aqueous penetration of ketorolac 0.4% compared with bromfenac 0.09% in cataract patients: Peak and trough drug concentrations. 3929/ B884. Proceedings of the 79th Annual Meeting of The Association for Research in Vision and Ophthalmology (ARVO), Ft. Lauderdale, FL, May 6-10, 2007.
15. 2 concentrations of ketorolac 0.4%, bromfenac 0.09%, and nepafenac 0.1% in patients undergoing vitrectomy. 5169/ B317. Proceedings of the 79th Annual Meeting of The Association for Research in Vision and Ophthalmology (ARVO), Ft. Lauderdale, FL, May 6-10, 2007.
16. Walters, T.R., Raizman, M., Ernest, P., et al. In vivo pharmacokinetics and in vitro pharmacodynamics of nepafenac, amfenac, ketorolac, and bromfenac. J. Cataract Refract. Surg. 33:1539-1545, 2007.
17. Ogawa, T., Sakaue, T., Terai, T., et. al. Effects of bromfenac sodium, nonsteroidal anti-inflammatory drug, on acute ocular inflammation. Acta. Soc. Ophthalmol. Jpn. 99:406-411, 1995.
18. Ogawa, T., and Sakaue, T. Effect of bromfenac sodium on bovine serum albumin induced-uveitis in rabbits. Folia. Ophthalmol. Jpn. 46:860-865, 1995.
19. Isaka, M., Inada, K., Tsutsumi, S., et. al. Ocular tissue distribution in rabbit after instillation of bromfenac sodium ophthalmic solution. Drug Metab. Pharmacokinet. 14:32-41, 1999.
20. Walsh, D.A., Moran, H.W., Shamblee, D.A., et al. Anti-inflammatory agents. 3. Synthesis and pharmacological evaluation of 2-amino-3- benzoylphenylacetic acid and analogues. J. Med. Chem. 11:1379-1388, 1984.
21. Ruiz, J., Lopez, M., Mila, J., et al. QSAR and conformational analysis of the anti-inflammatory agent amfenac and analogues. J. Comp. Aided Mol. Des. 7:183-198, 1993.
22. Sancilio, L.F., Nolan, J.C., Wagner, L.E., et al. The analgesic and anti-inflammatory activity and pharmacologic properties of bromfenac. Arzneimittelforschung 37:513-519, 1987.
23. Kida, T., Ogawa, T., McNamara, T.R., et al. Evaluations of the human COX-2 inhibition for amfenac, bromfenac, diclofenac, and ketorolac. P49. Proceedings of the 33rd Symposium on Cataract, IOL, and Refractive Surgery of the American Society of Cataract and Refractive Surgery (ASCRS) Meeting, San Diego, CA, April 27-May 1, 2007.
24. Bronuck® prescribing information. Senju Pharmaceutical Co. Ltd., Osaka, Japan, 2005.
25. Sawa, M., Masuda, K., Usui, M., et al. Efficacy of bromfenac sodium ophthalmic solution for ocular surface inflammation - a double-masked, controlled trial. Folia. Ophthalmol. Jpn. 48:717-724, 1997.
26. Masuda, K., Fukado, Y., Shimizu, H., et al. Effect of bromfenac sodium (AHR-10282B) on postoperative inflammation - a double-masked trial. Folia. Ophthalmol. Jpn. 48:560-569, 1997.
27. Xibrom™ (bromfenac ophthalmic solution) 0.09% prescribing information. ISTA Pharmaceuticals®, Inc., 2005.
28. Xibrom™ (bromfenac ophthalmic solution) 0.09% prescribing information. ISTA Pharmaceuticals®, Inc., 2006.
29. Ohara, K., Ohkubo, A., Miyamoto, T., et al. Prevention of miosis during cataract surgery by topical bromfenac sodium. Jpn. J. Clinic Ophthalmol. 58:1325-1328, 2004.
30. Gross, J. Xibrom™ (bromfenac) reduces cystoid macular edema associated with vein occlusions, macular epiretinal membrane, diabetic retinopathy, and age-related macular degeneration. Proceedings of the 40th Annual Retina Society Meeting, Boston, MA, September 27-30, 2007.
31. Usui, M., and Masuda, K. Effect of bromfenac sodium (AHR-10282B) eye drops on anterior uveitis. Ganka. Rinsho. Iho. (J. Rev. Clin. Ophthalmol.). 91:39-44, 1997.
32. Miyake-Kashima, M., Takano, Y., Tanaka, M., et al. Comparison of 0.1% bromfenac sodium and 0.1% pemirolast potassium for the treatment of allergic conjunctivitis. Jpn. J. Ophthalmol. 48:587-590, 2004.
33. Uchio, E., Itoh, Y., and Kadonosono, K. Topical bromfenac sodium for long-term management of vernal keratoconjunctivitis. Opthalmologica 221:153-158, 2007.
34. Givergis, R., Wang, X.J., and Chynn, E. Evaluation of the efficacy and safety of bromfenac vs. ketorolac for pain relief after LASEK, LASIK, and Epi-LASIK. Proceedings of the 33rd Symposium on Cataract, IOL, and Refractive Surgery of the American Society of Cataract and Refractive Surgery (ASCRS) Meeting, San Diego, CA, April 27-May 1, 2007.
35. Sher, N.A., Golben, M., Bond, W., et al. Randomized trial of topical bromfenac 0.09% versus ketorolac 0.4% for control of post-PRK pain and discomfort. Proceedings of the 33rd Symposium on Cataract, IOL, and Refractive Surgery of the American Society of Cataract and Refractive Surgery (ASCRS) Meeting, San Diego, CA, April 27-May 1, 2007.
36. Schechter, B.A. Evaluation of Xibrom™ 0.09% for the treatment of corneal ulcer pain. P181. Proceedings of the 33rd Symposium on Cataract, IOL, and Refractive Surgery of the American Society of Cataract and Refractive Surgery (ASCRS) Meeting, San Diego, CA, April 27-May 1, 2007.
37. Harris, L. Effectiveness and safety of bromfenac 0.09% used after pterygium surgery with amniotic membrane grafting and fibrin/thrombin tissue glue. Proceedings of the 33rd Symposium on Cataract, IOL, and Refractive Surgery of the American Society of Cataract and Refractive Surgery (ASCRS) Meeting, San Diego, CA, April 27-May 1, 2007.
38. Donnenfeld, E.D., Holland, E.J., Stewart, R.H., et al. Bromfenac ophthalmic solution 0.09% (Xibrom™) for postoperative ocular pain and inflammation. Ophthalmology 114:1653-1662, 2007.
39. Kawaguchi, T., Kida, T., Nemoto, S., et al. Effect of bromfenac ophthalmic solution on ocular inflammation and corneal epithelial barrier function following cataract surgery. Folia. Ophthalmol. Jpn. 54:276-279, 2003.
40. Ohara, K., Ohkubo, A., Miyamoto, T., et al. Effect of bromfenac sodium on postoperative inflammation. Jpn. J. Clinic. Ophthalmol. 18:1-12, 2004.
41. Takamatsu, F., Shiroyama, N., Saito, Y., et al. Efficacy and adverse effects of bromfenac ophthalmic solution following cataract surgery. Jpn. J. Clin. Ophthalmol. 57:1233-1237, 2003.
42. Schmitz, K., Banditt, P., Motschmann, M., et al. Population pharmacokinetics of 2% topical dorzolamide in the aqueous humor of humans. Invest. Opthalmol. Vis. Sci. 40:1621-1624, 1999.
43. Ellis, P.P., Pfoff, D.S., Bloedow, D.C., et al. Intraocular diclofenac and flurbiprofen concentrations in human aqueous humor following topical application. J. Ocul. Pharmacol. 10: 677-682, 1994.
44. Ikeda, H., Sato, M., Tsukamoto, H., et al. Evaluation and multivariate statistical analysis of factors influencing patient adherence to ophthalmic solutions. Yakugaku. Zasshi. 121: 799-806, 2001.