Rx Pharmaceuticals

Zylet® References

¹ US Department of Health and Human Services, Electronic Orange Book, April, 2006.
² Zylet product monograph, 2005. Bausch & Lomb.
³ Zylet® (Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension) [Package Insert]. Bausch & Lomb Incorporated; Tampa, Fl. January. 2006
⁴ Bartlett JD, Horwitz B. Laibovitz R, Howes JF. Intraocular pressure response to Loteprednol etabonate in known steroid responders. J Ocul Pharmacol. 1993;9:157-165.
⁵ Druzgala P, Hochhaus G, Bodor N. Soft drugs-10.Blanching activity and receptor binding affinity of a new type of glucocorticoid: loteprednol etabonate. J Steroid Biochem Molec Biol. 1991;38:149-154.
⁶ Martha Alberth, Whei-Mei Wu, David Winwood and Nicholas Bodor. Lipophilicity, Solubility, and Permeability of Loteprednol Etabonate; A Novel Soft Anti-Inflammatory Corticosteroid. Journal of Biopharmaceutical Sciences. 1991. 2(2), 115-125
⁷ Novack GD, Howes J, Crockett RS, Sherwood MB. Change in intraocular pressure during long-term use of loteprednol etabonate. J Glaucoma. 1998;7:266-269.
⁸ American Optometric Association. Ocular hypertension. Available at http://www.aoa.org Accessed December 3, 2004.
⁹ EyeMDlink.Steroid induced glaucoma. Available at: http://www.eyemdlink.com Accessed November 16, 2004.
¹⁰ U.S. Census Bureau. U.S. POPClock projection. Available at:http://www.census.gov/cgi-bin/popclock. Accessed November 16, 2004.
¹¹ eMedicine Consumer Health.Ocular hypertension. Available at: http://www.emedicinehealth.com/articles/37513-1.asp Accessed November 16, 2004.
¹² All About Vision. Glaucoma:the second-leading cause of blindness in the U.S. Available at: http://www.allaboutvision.com/conditions/glaucoma.htm Accessed November 16, 2004.
¹³ Lotemax (loteprednol etabonate opthalmic suspension 0.5%) (package insert) Tampa, FL: Bausch & Lomb Incorporated, May 2005
¹⁴ Bodor N. Novel approaches to the design of safer drugs: soft drugs and site-specific chemical delivery systems. Adv Drug Res. 1984; 255-331.
¹⁵ Bodor N. Designing safer ophthalmic drugs by soft drug approaches. J Ocul Pharmacol. 1994;10:3-15
¹⁶ Armaly MF. Statistical attributes of the steroid hypertensive response in the clinically normal eye: the demonstration of the three levels of response. Invest Ophthalmol. 1965;4:187-197
¹⁷ Manabe S, Bucala R, Cerami A. Nonenzymatic addition of glucocorticoids to lens proteins in steroid-induced cataracts. J Clin Invest. 1984;74:1803-1810
¹⁸ Howes J, Novack GD. Failure to detect systemic levels, and effects of Loteprednol etabonate and its metabolite, PJ-91 following chronic ocular administration. J Ocul Pharmacol Ther. 1998; 14:153-158.
¹⁹ Friedlaender MH et al. A Double-Masked Placebo-Controlled Evaluation of the Efficacy and Safety of Loteprednol Etabonate and Safety or Loteprenol Etabonate in the Treatment of Giant Papillary Conjunctivitis. Am J Ophthalmol. 1997;123:455-464.
²⁰ US Dept. of Health and Human Services Orange Book, April 2006.
²¹ de Aguiar Moeller CT, Branco BC, Zorat-Yu MC, Farah ME, de Lim ALH, Alterations in ocular pathogen susceptibility to gentamicin and tobramycin. Arg Bras Oftalmol. 1999;62.
²² Laibson P, Michaud R, Smolin G, Okumoto M, Rosenthal A, Cagle G. A clinical comparison of tobramycin and gentamicin sulfate in the treatment of ocular infections. Am J Ophthalmol. 1981;92:836-841
²³ Novack GD, ant the Loteprednol Etabonate Postoperative Inflammation Study Group 2. A double-masked, placebo-controlled evaluation of loteprednol etabonate 0.5% in the treatment of postoperative inflammation. Ophthalmology. 1998;105:1780-1786.
²⁴ Stewart R et al. J Cataract Refract Surg. A Double-Masked Placebo-Controlled Evaluation of Loteprednol Etabonate 0.5% for Postoperative Inflammation. 1998;24:1480-1489.
²⁵ Dell SJ, Shulman DG, Lowry GM, Howes J, for the Loteprednol Allergic Conjunctivitis Study Group. A controlled evaluation of efficacy and safety of loteprednol etabonate in the prophylactic treatment of seasonal allergic conjunctivitis. AM J Ophthalmol. 1997;123:791-797.
²⁶ Asbell H et al. A Double-Masked Placebo-Controlled Evaluation of the Efficacy and Safety of Loteprednol Etabonate and Safety of Loteprenol Etabonate in the treatment of Giant Papillary Conjunctivitis. CLAO J. 1997;23:31-36.
²⁷ Cagle G, Davis S, Rosenthal A, Smith J. Topical tobramycin and gentamicin sulfate in the treatment of ocular infections: multicenter study. Curr Eye Res. 1981/1982;1:523-534.
²⁸ Dajcs, Moreau, Stoman, et al. The Effectiveness of Tobramycin and Ocuflux in a prophylaxis model of Staphylococcus Keratitis.
²⁹ Robert P-Y, Adenis J-P. Comparative review of topical ophthalmic antibacterial preparations. Drugs. 2001;61:175-185.
³⁰ Data on file, Bausch & Lomb Incorporated, NDA 50-804, 2004.
³¹ Gary D. Novak, R. S. Crockett, J. Howes. Controlled Evaluation of Loteprednol Etabonate and Prednisolone Acetate in the Treatment of Acute Anterior Uveitis. American Journal of Ophthalmology. 1999; Vol 127, No 5.