270
Views
1
CrossRef citations to date
0
Altmetric
ORIGINAL RESEARCH

OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2

, , , , , , & show all
Pages 725-734 | Received 07 Jan 2023, Accepted 21 Feb 2023, Published online: 03 Mar 2023

References

  • 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
  • Tsubota K, Pflugfelder SC, Liu Z, et al. Defining dry eye from a clinical perspective. Int J Mol Sci. 2020;21(23):9271. doi:10.3390/ijms21239271
  • Nguyen CQ, Peck AB. Unraveling the pathophysiology of Sjogren syndrome-associated dry eye disease. Ocul Surf. 2009;7(1):11–27. doi:10.1016/S1542-0124(12)70289-6
  • Yu K, Bunya V, Maguire M, et al. Systemic conditions associated with severity of dry eye signs and symptoms in the dry eye assessment and management study. Ophthalmology. 2021;128(10):1384–1392. doi:10.1016/j.ophtha.2021.03.030
  • Wang H, Wang PB, Chen T, et al. Analysis of clinical characteristics of immune-related dry eye. J Ophthalmol. 2017;2017:8532397. doi:10.1155/2017/8532397
  • Moscovici BK, Holzchuh R, Sakassegawa-Naves FE, et al. Treatment of Sjogren’s syndrome dry eye using 0.03% tacrolimus eye drop: prospective double-blind randomized study. Cont Lens Anterior Eye. 2015;38(5):373–378. doi:10.1016/j.clae.2015.04.004
  • Moawad P, Shamma R, Hassanein D, Ragab G, El Zawahry O. Evaluation of the effect of topical tacrolimus 0.03% versus cyclosporine 0.05% in the treatment of dry eye secondary to Sjogren syndrome. Eur J Ophthalmol. 2022;32(1):673–679. doi:10.1177/1120672121992680
  • Deveci H, Kobak S. The efficacy of topical 0.05 % cyclosporine A in patients with dry eye disease associated with Sjögren’s syndrome. Int Ophthalmol. 2014;34(5):1043–1048. doi:10.1007/s10792-014-9901-4
  • Kang MJ, Kim YH, Chou M, et al. Evaluation of the efficacy and safety of a novel 0.05% cyclosporin A topical nanoemulsion in primary Sjögren’s syndrome dry eye. Ocul Immunol Inflamm. 2020;28(3):370–378. doi:10.1080/09273948.2019.1587470
  • Cubuk MO, Ucgul AY, Ozgur A, Ozulken K, Yuksel E. Topical cyclosporine a (0.05%) treatment in dry eye patients: a comparison study of Sjogren’s syndrome versus non-Sjogren’s syndrome. Int Ophthal. 2021;41(4):1479–1485. doi:10.1007/s10792-021-01708-1
  • de Paiva CS, Pflugfelder SC, Ng SM, Akpek EK. Topical cyclosporine A therapy for dry eye syndrome. Cochrane Database Syst Rev. 2019;9:CD010051. doi:10.1002/14651858.CD010051.pub2
  • Nau J, Wyatt DJ, Rollema H, Crean CS. A Phase I, open-label, randomized, 2-Way crossover study to evaluate the relative bioavailability of intranasal and oral varenicline. Clin Ther. 2021;43(9):1595–1607. doi:10.1016/j.clinthera.2021.07.020
  • TyrvayaTM (varenicline solution) nasal spray [package insert]. Princeton, NJ: Oyster Point Pharma, Inc; 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213978s000lbl.pdf. Accessed February 22, 2023.
  • Wirta D, Torkildsen G, Boehmer B, et al. ONSET-1 phase 2b randomized trial to evaluate the safety and efficacy of OC-01 (varenicline solution) nasal spray on signs and symptoms of dry eye disease. Cornea. 2022;41(10):1207–1216. doi:10.1097/ICO.0000000000002941
  • Wirta D, Vollmer P, Paauw J, et al. Efficacy and safety of OC-01 (varenicline) nasal spray on signs and symptoms of dry eye disease: the ONSET-2 phase 3, randomized trial. Ophthalmology. 2022;129(4):379–387. doi:10.1016/j.ophtha.2021.11.004
  • Quiroz-Mercado H, Hernandez-Quintela E, Chiu KH, Henry E, Nau JA. A Phase II randomized trial to evaluate the long-term (12-week) efficacy and safety of OC-01 (varenicline solution) nasal spray for dry eye disease: the MYSTIC study. Ocul Surf. 2021;24:15–21. doi:10.1016/j.jtos.2021.12.007
  • Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine--reporting of subgroup analyses in clinical trials. N Engl J Med. 2007;357(21):2189–2194. doi:10.1056/NEJMsr077003
  • Meadows JF, Dionne K, Nichols KK. Differential profiling of T-Cell cytokines as measured by protein microarray across dry eye subgroups. Cornea. 2016;35(3):329–335. doi:10.1097/ICO.0000000000000721
  • Gao Y, Min K, Zhang Y, Su J, Greenwood M, Gronert K. Female-specific downregulation of tissue polymorphonuclear neutrophils drives impaired regulatory T Cell and amplified effector T Cell responses in autoimmune dry eye disease. J Immunol. 2015;195(7):3086–3099. doi:10.4049/jimmunol.1500610
  • Sheppard JD, O’Dell LE, Karpecki PM, et al. Does dry eye disease severity impact efficacy of varenicline solution nasal spray on sign & symptom treatment outcomes? Optom Vis Sci. 2022;2012:1.
  • Zhu L, Shen J, Zhang C, et al. Inflammatory cytokine expression on the ocular surface in the Botulinum toxin B induced murine dry eye model. Mol Vis. 2009;15:250–258.
  • Guannan H, Long S, Xia H, Dong W, Shaozhen Z. Clinical characterisation and cytological study of dry eye in patients with autoimmune disease. J Pak Med Assoc. 2018;68(3):353–358.
  • Perzynska-Mazan J, Maslinska M, Gasik R. Neurophysiological features of peripheral nervous system involvement and immunological profile of patients with primary Sjögren syndrome. J Rheumatol. 2020;47(11):1661–1667. doi:10.3899/jrheum.181464
  • Jin K, Imada T, Hisamura R, et al. Identification of lacrimal gland postganglionic innervation and its regulation of tear secretion. Am J Pathol. 2020;190(5):1068–1079. doi:10.1016/j.ajpath.2020.01.007
  • Sumida T, Tsuboi H, Iizuka M, Asashima H, Matsumoto I. Anti-M3 muscarinic acetylcholine receptor antibodies in patients with Sjögren’s syndrome. Mod Rheumatol. 2013;23(5):841–845. doi:10.3109/s10165-012-0788-5
  • Tsuboi H, Matsumoto I, Wakamatsu E, et al. New epitopes and function of anti-M3 muscarinic acetylcholine receptor antibodies in patients with Sjögren’s syndrome. Clin Exp Immunol. 2010;162(1):53–61. doi:10.1111/j.1365-2249.2010.04188.x
  • Waterman SA, Gordon TP, Rischmueller M. Inhibitory effects of muscarinic receptor autoantibodies on parasympathetic neurotransmission in Sjögren’s syndrome. Arthritis Rheum. 2000;43(7):1647–1654. doi:10.1002/1529-0131(200007)43:7<1647::AID-ANR31>3.0.CO;2-P
  • Musayeva A, Jiang S, Ruan Y, et al. Aged mice devoid of the M3 muscarinic acetylcholine receptor develop mild dry eye disease. Int J Mol Sci. 2021;22(11):6133. doi:10.3390/ijms22116133
  • Dawson LJ, Allison HE, Stanbury J, Fitzgerald D, Smith PM. Putative anti-muscarinic antibodies cannot be detected in patients with primary Sjogren’s syndrome using conventional immunological approaches. Rheumatology. 2004;43(12):1488–1495. doi:10.1093/rheumatology/keh389
  • Dartt DA, Hodges RR. Cholinergic agonists activate P2X7 receptors to stimulate protein secretion by the rat lacrimal gland. Invest Ophthalmol Vis Sci. 2011;52(6):3381–3390. doi:10.1167/iovs.11-7210