122
Views
5
CrossRef citations to date
0
Altmetric
Clinical Trial Report

Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety Evaluation of OTX-101 in Patients with Keratoconjunctivitis Sicca

, , , ORCID Icon, & ORCID Icon
Pages 129-140 | Published online: 12 Jan 2021

References

  • Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report. Ocul Surf. 2017;15(3):276–283. doi:10.1016/j.jtos.2017.05.008
  • Craig JP, Nelson JD, Azar DT, et al. TFOS DEWS II report executive summary. Ocul Surf. 2017;15(4):802–812. doi:10.1016/j.jtos.2017.08.003
  • Wolffsohn JS, Arita R, Chalmers R, et al. TFOS DEWS II diagnostic methodology report. Ocul Surf. 2017;15(3):539–574. doi:10.1016/j.jtos.2017.05.001
  • Stapleton F, Alves M, Bunya VY, et al. TFOS DEWS II epidemiology report. Ocul Surf. 2017;15(3):334–365. doi:10.1016/j.jtos.2017.05.003
  • Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf. 2017;15(3):575–628. doi:10.1016/j.jtos.2017.05.006
  • Messmer EM. The pathophysiology, diagnosis, and treatment of dry eye disease. Dtsch Arztebl Int. 2015;112(5):71–81;quiz 82. doi:10.3238/arztebl.2015.0071
  • Rhee MK, Mah FS. Clinical utility of cyclosporine (CsA) ophthalmic emulsion 0.05% for symptomatic relief in people with chronic dry eye: a review of the literature. Clin Ophthalmol. 2017;11:1157–1166. doi:10.2147/OPTH.S113437
  • Lallemand F, Schmitt M, Bourges JL, Gurny R, Benita S, Garrigue JS. Cyclosporine A delivery to the eye: a comprehensive review of academic and industrial efforts. Eur J Pharm Biopharm. 2017;117::14–28. doi:10.1016/j.ejpb.2017.03.006
  • Kuwano M, Ibuki H, Morikawa N, Ota A, Kawashima Y. Cyclosporine A formulation affects its ocular distribution in rabbits. Pharm Res. 2002;19(1):108–111. doi:10.1023/A:1013671819604
  • CEQUATM (cyclosporine opthalmic solution 0.09%). Full prescribing information. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2018.
  • Cholkar K, Gilger BC, Mitra AK. Topical, aqueous, clear cyclosporine formulation design for anterior and posterior ocular delivery. Transl Vis Sci Technol. 2015;4(3):1. doi:10.1167/tvst.4.3.1
  • Weiss SL, Kramer WG. Ocular distribution of cyclosporine following topical administration of OTX-101 in New Zealand white rabbits. J Ocul Pharmacol Ther. 2019;35(7):395–402. doi:10.1089/jop.2018.0106
  • Tauber JSB, Bacharach J, Toyos MM, Smyth-Medina R, Weiss SL, Luchs JI. A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease. Clin Ophthalmol. 2018;12:1921–1929. doi:10.2147/OPTH.S175065
  • Goldberg DF, Malhotra RP, Schechter BA, Justice A, Weiss SL, Sheppard JD. A Phase 3, randomized, double-masked study of OTX-101 ophthalmic solution 0.09% in the treatment of dry eye disease. Ophthalmology. 2019;126(9):1230–1237. doi:10.1016/j.ophtha.2019.03.050
  • Malhotra R, Devries DK, Luchs J, et al. Effect of OTX-101, a novel nanomicellar formulation of Cyclosporine A, on Corneal staining in patients with keratoconjunctivitis sicca: a pooled analysis of Phase 2b/3 and Phase 3 studies. Cornea. 2019;38(10):1259–1265. doi:10.1097/ICO.0000000000001989
  • Smyth-Medina R, Johnston J, Devries DK, et al. Effect of OTX-101, a novel nanomicellar formulation of Cyclosporine A, on conjunctival staining in patients with keratoconjunctivitis sicca: a pooled analysis of Phase 2b/3 and 3 clinical trials. J Ocul Pharmacol Ther. 2019;35(7):388–394. doi:10.1089/jop.2018.0154
  • Sheppard J, Kannarr S, Luchs J, et al. Efficacy and safety of OTX-101, a novel nanomicellar formulation of Cyclosporine A, for the treatment of keratoconjunctivitis sicca: pooled analysis of a Phase 2b/3 and Phase 3 study. Eye Contact Lens. 2020;46(Suppl 1):S14–S19. doi:10.1097/ICL.0000000000000636
  • Deveney T, Asbell PA. Patient and physician perspectives on the use of cyclosporine ophthalmic emulsion 0.05% for the management of chronic dry eye. Clin Ophthalmol. 2018;12:569–576. doi:10.2147/OPTH.S115098
  • RESTASIS® (cyclosporine ophthalmic emulsion) 0.05% for topical ophthalmic use. Full prescribing information. Irvine, CA: Allergan; 2017.