119
Views
6
CrossRef citations to date
0
Altmetric
ORIGINAL RESEARCH

Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies

, , &
Pages 1427-1438 | Published online: 01 Aug 2019

References

  • Grob SR, Gonzalez-Gonzalez LA, Daly MK. Management of mydriasis and pain in cataract and intraocular lens surgery: review of current medications and future directions. Clin Ophthalmol. 2014;8:1281–1289.
  • McGhee CN, Dean S, Danesh-Meyer H. Locally administered ocular corticosteroids: benefits and risks. Drug Saf. 2002;25(1):33–55. doi:10.2165/00002018-200225010-00004
  • Pleyer U, Ursell PG, Rama P. Intraocular pressure effects of common topical steroids for post-cataract inflammation: are they all the same? Ophthalmol Ther. 2013;2(2):55–72. doi:10.1007/s40123-013-0020-5
  • Comstock TL, DeCory HH. Advances in corticosteroid therapy for ocular inflammation: loteprednol etabonate. Int J Inflam. 2012;789623.
  • Comstock TL, Sheppard JD. Loteprednol etabonate for inflammatory conditions of the anterior segment of the eye: twenty years of clinical experience with a retrometabolically designed corticosteroid. Expert Opin Pharmacother. 2018;19(4):337–353. doi:10.1080/14656566.2018.149920
  • Sheppard JD, Comstock TL, Cavet ME. Impact of the topical ophthalmic corticosteroid loteprednol etabonate on intraocular pressure. Adv Ther. 2016;33(4):532–552. doi:10.1007/s12325-016-0315-8
  • Lotemax [package insert]. Bridgewater, NJ; Bausch & Lomb Incorporated; 2016.
  • Lane SS, Holland EJ. Loteprednol etabonate 0.5% versus prednisolone acetate 1.0% for the treatment of inflammation after cataract surgery. J Cataract Refract Surg. 2013;39(2):168–173. doi:10.1016/j.jcrs.2012.10.039
  • Lotemax gel [package insert]. Bridgewater, NJ; Bausch & Lomb Incorporated; 2018.
  • United States Food and Drug Administration. Drug approval package 2012. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202872_lotemax_toc.cfm. Accessed July 12, 2018.
  • Coffey MJ, DeCory HH, Lane SS. Development of a non-settling gel formulation of 0.5% loteprednol etabonate for anti-inflammatory use as an ophthalmic drop. Clin Ophthalmol. 2013;7:299–312.
  • Abessi B, Brooksby L, Schultze RL. Comparison of efficacy of difluprednate 0.05% and loteprednol gel 0.5% after cataract surgery. Eye Contact Lens. 2018;44(Suppl 2):S37–S42. doi:10.1097/ICL.0000000000000407
  • Fong R, Leitritz M, Siou-Mermet R, Erb T. Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial. Clin Ophthalmol. 2012;6:1113–1124. doi:10.2147/OPTH.S32643
  • Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013;30(10):907–923. doi:10.1007/s12325-013-0059-7
  • Rajpal RK, Roel L, Siou-Mermet R, Erb T. Efficacy and safety of loteprednol etabonate 0.5% gel in the treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2013;39(2):158–167. doi:10.1016/j.jcrs.2012.09.013
  • Cavet ME, Glogowski S, Lowe ER, Phillips E. Rheological properties, dissolution kinetics, and ocular pharmacokinetics of loteprednol etabonate (submicron) ophthalmic gel 0.38%. J Ocul Pharmacol Ther. 2019;35:291–300. doi:10.1089/jop.2018.0136
  • Google Patents. Loteprednol acetate suspension eye drops. Available from: https://patents.google.com/patent/CN103565740A/en. Accessed January 29, 2019.
  • Lotemax SM [package insert]. Bridgewater, NJ, Baush & Lomb Incorporated; 2019.
  • Steil CF, Covington TR. Pharmaceutical and regulatory aspect of ophthalmic drug administration. In: Bartlett JD, Januus SD, editors. Clinical Ocular Pharmacology. 5th ed. St Louis, MO: Butterworth-Heinemann; 2008:53–62.
  • Fong R, Silverstein BE, Peace JH, Williams JI, Vittitow JL. Submicron loteprednol etabonate ophthalmic gel 0.38% for the treatment of inflammation and pain after cataract surgery. J Cataract Refract Surg. 2018;44(10):1220–1229. doi:10.1016/j.jcrs.2018.06.056
  • Vittitow JL, LoBue T, Martel J. Safety and efficacy of a novel submicron loteprednol etabonate gel in the treatment of inflammation and pain post-cataract surgery. Invest Ophthalmol Vis Sci. 2018;59(9):2235. doi:10.1167/iovs.17-23678
  • Kim T, Sall K, Holland EJ, Brazzell RK, Coultas S, Gupta PK. Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery. Clin Ophthalmol. 2018;13:69–86. doi:10.2147/OPTH.S185800
  • Inveltys [package insert]. Waltham, MA; Kala Pharmaceuticals, Inc; 2018.
  • Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS; Difluprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group. Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. J Cataract Refract Surg. 2009;35(1):26–34. doi:10.1016/j.jcrs.2008.09.024
  • Smith S, Lorenz D, Peace J, McLeod K, Crockett RS, Vogel R. Difluprednate ophthalmic emulsion 0.05% (Durezol) administered two times daily for managing ocular inflammation and pain following cataract surgery. Clin Ophthalmol. 2010;4:983–991. doi:10.2147/OPTH.S10696
  • Noyes AA, Whitney WR. The rate of solution of solid substances in their own solutions. J Am Chem Soc. 1897;19(12):930–934. doi:10.1021/ja02086a003
  • Jambhekar SS, Breen PJ. Drug dissolution: significance of physicochemical properties and physiological conditions. Drug Discov Today. 2013;18(23–24):1173–1184. doi:10.1016/j.drudis.2013.08.013