Research Article
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Year 2022, Volume: 13 Issue: 2, 241 - 246, 15.03.2022

C: Banu Coşar Ayşe Ebru Kılavuzoğlu Ali Riza Cenk Celebi Uğur Emrah Altıparmak

https://doi.org/10.31067/acusaglik.871316

Abstract

References

  • 1. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report. Ocul Surf 2017; 15(3): 276-283.
  • 2. Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf 2017; 15(3): 575-628.
  • 3. J.M. Barbarino, C.E. Staatz, R. Venkataramanan, T.E. Klein, R.B. Altman. PharmGKB summary: cyclosporine and tacrolimus pathways. Pharmacogenet Genomics 2013; 23(10): 563-585.
  • 4. E. Donnenfeld, S.C. Pflugfelder. Topical ophthalmic cyclosporine: pharmacology and clinical uses. Surv Ophthalmol 2009; 54(3): 321-338.
  • 5. S. Matsuda, S. Koyasu. Mechanisms of action of cyclosporine. Immunopharmacology 2000; 47(2–3): 119-125.
  • 6. Kunert KS, Tisdale AS, Stern ME, Smith JA, Gipson IK. Analysis of topical cyclosporine treatment of patients with dry eye syndrome: effect on conjunctival lymphocytes. Arch Ophthalmol 2000; 118(11): 1489-1496.
  • 7. Brignole F, Pisella PJ, De Saint Jean M, Goldschild M, Goguel A, Baudouin C. Flow cytometric analysis of inflammatory markers in KCS: 6-month treatment with topical cyclosporine A. Invest Ophthalmol Vis Sci 2001; 42(1): 90-95.
  • 8. Sullivan BD, Crews LA, Sönmez B, de la Paz MF, Comert E, Charoenrook V, et al. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea 2012; 31(9). 1000-1008.
  • 9. Gao J, Sana R, Calder V, Calonge M, Lee W, Wheeler LA, et al. Mitochondrial permeability transition pore in inflammatory apoptosis of human conjunctival epithelial cells and T cells: effect of cyclosporine A. Invest Ophthalmol Vis Sci 2013; 54(7): 4717-4733.
  • 10. K. Tsubota, H. Fujita, K. Tadano, T. Takeuchi, T. Murakami, I. Saito, et al. Improvement of lacrimal function by topical application of CyA in murine models of Sjögren's syndrome. Invest Ophthalmol Vis Sci 2001; 42(1): 101-110.
  • 11. Sall K, Stevenson OD, Mundorf TK, Reis BL. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group, Ophthalmology 2000; 107(4): 631-639.
  • 12. Pflugfelder SC, De Paiva CS, Villarreal AL, Stern ME. Effects of sequential artificial tear and cyclosporine emulsion therapy on conjunctival goblet cell density and transforming growth factor-beta2 production. Cornea 2008; 27(1): 64-69.
  • 13. El tayar N, Mark AE, Vallat P, et al. Solvent-dependent conformation and hydrogen-bonding capacity of cyclosporine A: evidence from partition coefficients and molecular dynamics simulations. J Med Chem 1993; 36(24): 3757-3764.
  • 14. Schulltz C. Safety and efficacy of cyclosporine in the treatment of chronic dry eye. Ophthalmol Eye Dis 2014; 6: 37-42.
  • 15. Patel D, Wairkar S. Recent advances in cyclosporine drug delivery. Challenges and opportunities. Drug Delivery and Translational Research 2019; 9: 1067-1081.
  • 16. Perry H, Solomon R, Donnenfeld ED, et al. Evaluation of topical cyclosporine for the treatment of dry eye disease. Arch Ophthalmol 2008; 126(8): 1046-1050.
  • 17. Oliveira RC, Wilson SE. Practical guidance for the use of cyclosporine ophthalmic solutions in the management of dry eye disease. Clin Ophthalmol 2019; 13: 1115-1122.
  • 18. European Medicines Agency, Generic and Hybrid Medicines. Available at: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/generic-hybrid-medicines
  • 19. Branded vs. Generics: You make the call. Ophthalmology Times. December 6, 2018. Available at: https://www.ophthalmologytimes.com/article/branded-vs-generics-you-make-call
  • 20. Barber LD, Pflugfelder SC, Tauber J, Foulks GN. Phase III safety evaluation of cyclosporine 0.1% ophthalmic emulsion administered twice daily to dry eye disease patients for up to 3 years. Ophthalmology 2005; 112(10): 1790-1794.
  • 21. Holland EJ, Darvish M, Nichols KK, Jones L, Karpecki PM. Efficacy of topical ophthalmic drugs in the treatment of dry eye disease: A systematic literature review. Ocul Surf 2019; 17(3): 412-423.
  • 22. Wan KH, Chen LJ, Young AL. Efficacy and safety of topical %0.05 cyclosporine eye drops in the treatment of dry eye syndrome: A systematic review and meta-analysis. Ocul Surf 2015; 13(3):213-225.
  • 23. Stevenson D, Tauber J, Reis BL. Efficacy and safety of cyclosporine A ophthalmic emulsion in the treatment of moderate-to-severe dry eye disease: a dose-ranging, randomized trial. The cyclosporine a phase 2 study group. Ophthalmology 2000; 107(5): 967-974.
  • 24. Sheppard JD, Donnenfeld ED, Holland EJ, et al. Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%. Eye & Contact Lens 2014; 40(5): 289-296.
  • 25. Singla S, Sarkar L, Joshi M. Comparison of topical cyclosporine alone and topical loteprednol with cyclosporine in moderate dry eye in Indian population. A prospective study. Taiwan J Ophthalmol 2019; 9(3): 173-18.
  • 26. Food and Drug Administration. Restasis (cyclosporine ) ophthalmic label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050790s027lbl.pdf
  • 27. Sheppard JD, Scoper VS, Samudre S. Topical loteprednol pretreatment reduces cyclosporine stinging in chronic dry eye disease. J Ocul Pharmacol Ther 2011; 27(1): 23-27.

Generic Cyclosporine in the Treatment of Dry Eye Disease

Year 2022, Volume: 13 Issue: 2, 241 - 246, 15.03.2022

C: Banu Coşar Ayşe Ebru Kılavuzoğlu Ali Riza Cenk Celebi Uğur Emrah Altıparmak

https://doi.org/10.31067/acusaglik.871316

Abstract

Objectives: To investigate the efficacy and safety of a generic Cyclosporine 0.05% ophthalmic emulsion in chronic dry eye disease.
Materails and Methods: Thirty patients with dry eye disease were included in this observational, prospective study. Patients were examined at baseline, at month -1,-3 and 6 of the study. The following were evaluated at each visit: CDVA (corrected distance visual acuity), corneal and conjunctival staining (Oxford) score, TBUT (tear break-up time), Schirmer-2 score, OSDI (Ocular Surface Disease Index) score, patient’s subjective rating scale of ocular discomfort, daily use of concomittant artificial tears, the researcher's assessment of the global treatment response, and IOP (intraocular pressure). In addition, drug-related side effects were evaluated individually in each examination. When initiating dry eye treatment, cyclosporine was combined with topical loteprednol etabonate 0.5%.
Results: There was a statistically significant improvement from baseline in corneal and conjunctival staining (decrease in mean Oxford score), TBUT, Schirmer-2 values, OSDI score, patient’s subjective rating score for ocular discomfort, and mean physician’s subjective assessment of global response to treatment at all follow-up visits (p<0.001). The mean daily use of artifical drops decreased statistically at all time points (<0.001). The most commonly reported adverse events were ocular burning (6.7%), followed by stinging (3.3%), conjunctival hyperemia (3.3%), foreign body sensation (3.3%), and visual disturbance (3.3%).

Conclusion: Generic cyclosporine 0.05% ophthalmic emulsion with loteprednol etabonate 0.5% on initiation treatment has well-tolerability and improves subjective and objective measures of dry eye disease.

Keywords

dry eye syndromes cyclosporine generic equivalency

References

  • 1. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report. Ocul Surf 2017; 15(3): 276-283.
  • 2. Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf 2017; 15(3): 575-628.
  • 3. J.M. Barbarino, C.E. Staatz, R. Venkataramanan, T.E. Klein, R.B. Altman. PharmGKB summary: cyclosporine and tacrolimus pathways. Pharmacogenet Genomics 2013; 23(10): 563-585.
  • 4. E. Donnenfeld, S.C. Pflugfelder. Topical ophthalmic cyclosporine: pharmacology and clinical uses. Surv Ophthalmol 2009; 54(3): 321-338.
  • 5. S. Matsuda, S. Koyasu. Mechanisms of action of cyclosporine. Immunopharmacology 2000; 47(2–3): 119-125.
  • 6. Kunert KS, Tisdale AS, Stern ME, Smith JA, Gipson IK. Analysis of topical cyclosporine treatment of patients with dry eye syndrome: effect on conjunctival lymphocytes. Arch Ophthalmol 2000; 118(11): 1489-1496.
  • 7. Brignole F, Pisella PJ, De Saint Jean M, Goldschild M, Goguel A, Baudouin C. Flow cytometric analysis of inflammatory markers in KCS: 6-month treatment with topical cyclosporine A. Invest Ophthalmol Vis Sci 2001; 42(1): 90-95.
  • 8. Sullivan BD, Crews LA, Sönmez B, de la Paz MF, Comert E, Charoenrook V, et al. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea 2012; 31(9). 1000-1008.
  • 9. Gao J, Sana R, Calder V, Calonge M, Lee W, Wheeler LA, et al. Mitochondrial permeability transition pore in inflammatory apoptosis of human conjunctival epithelial cells and T cells: effect of cyclosporine A. Invest Ophthalmol Vis Sci 2013; 54(7): 4717-4733.
  • 10. K. Tsubota, H. Fujita, K. Tadano, T. Takeuchi, T. Murakami, I. Saito, et al. Improvement of lacrimal function by topical application of CyA in murine models of Sjögren's syndrome. Invest Ophthalmol Vis Sci 2001; 42(1): 101-110.
  • 11. Sall K, Stevenson OD, Mundorf TK, Reis BL. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group, Ophthalmology 2000; 107(4): 631-639.
  • 12. Pflugfelder SC, De Paiva CS, Villarreal AL, Stern ME. Effects of sequential artificial tear and cyclosporine emulsion therapy on conjunctival goblet cell density and transforming growth factor-beta2 production. Cornea 2008; 27(1): 64-69.
  • 13. El tayar N, Mark AE, Vallat P, et al. Solvent-dependent conformation and hydrogen-bonding capacity of cyclosporine A: evidence from partition coefficients and molecular dynamics simulations. J Med Chem 1993; 36(24): 3757-3764.
  • 14. Schulltz C. Safety and efficacy of cyclosporine in the treatment of chronic dry eye. Ophthalmol Eye Dis 2014; 6: 37-42.
  • 15. Patel D, Wairkar S. Recent advances in cyclosporine drug delivery. Challenges and opportunities. Drug Delivery and Translational Research 2019; 9: 1067-1081.
  • 16. Perry H, Solomon R, Donnenfeld ED, et al. Evaluation of topical cyclosporine for the treatment of dry eye disease. Arch Ophthalmol 2008; 126(8): 1046-1050.
  • 17. Oliveira RC, Wilson SE. Practical guidance for the use of cyclosporine ophthalmic solutions in the management of dry eye disease. Clin Ophthalmol 2019; 13: 1115-1122.
  • 18. European Medicines Agency, Generic and Hybrid Medicines. Available at: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/generic-hybrid-medicines
  • 19. Branded vs. Generics: You make the call. Ophthalmology Times. December 6, 2018. Available at: https://www.ophthalmologytimes.com/article/branded-vs-generics-you-make-call
  • 20. Barber LD, Pflugfelder SC, Tauber J, Foulks GN. Phase III safety evaluation of cyclosporine 0.1% ophthalmic emulsion administered twice daily to dry eye disease patients for up to 3 years. Ophthalmology 2005; 112(10): 1790-1794.
  • 21. Holland EJ, Darvish M, Nichols KK, Jones L, Karpecki PM. Efficacy of topical ophthalmic drugs in the treatment of dry eye disease: A systematic literature review. Ocul Surf 2019; 17(3): 412-423.
  • 22. Wan KH, Chen LJ, Young AL. Efficacy and safety of topical %0.05 cyclosporine eye drops in the treatment of dry eye syndrome: A systematic review and meta-analysis. Ocul Surf 2015; 13(3):213-225.
  • 23. Stevenson D, Tauber J, Reis BL. Efficacy and safety of cyclosporine A ophthalmic emulsion in the treatment of moderate-to-severe dry eye disease: a dose-ranging, randomized trial. The cyclosporine a phase 2 study group. Ophthalmology 2000; 107(5): 967-974.
  • 24. Sheppard JD, Donnenfeld ED, Holland EJ, et al. Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%. Eye & Contact Lens 2014; 40(5): 289-296.
  • 25. Singla S, Sarkar L, Joshi M. Comparison of topical cyclosporine alone and topical loteprednol with cyclosporine in moderate dry eye in Indian population. A prospective study. Taiwan J Ophthalmol 2019; 9(3): 173-18.
  • 26. Food and Drug Administration. Restasis (cyclosporine ) ophthalmic label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050790s027lbl.pdf
  • 27. Sheppard JD, Scoper VS, Samudre S. Topical loteprednol pretreatment reduces cyclosporine stinging in chronic dry eye disease. J Ocul Pharmacol Ther 2011; 27(1): 23-27.
There are 27 citations in total.

Details

Primary Language English
Subjects Ophthalmology
Journal Section Research Articles
Authors

C: Banu Coşar 0000-0002-4018-9798

Ayşe Ebru Kılavuzoğlu 0000-0001-8990-9365

Ali Riza Cenk Celebi 0000-0002-7952-1241

Uğur Emrah Altıparmak 0000-0002-3262-5959

Publication Date March 15, 2022
Submission Date May 17, 2021
Published in Issue Year 2022Volume: 13 Issue: 2

Cite

EndNote Coşar CB, Kılavuzoğlu AE, Celebi ARC, Altıparmak UE (March 1, 2022) Generic Cyclosporine in the Treatment of Dry Eye Disease. Acıbadem Üniversitesi Sağlık Bilimleri Dergisi 13 2 241–246.
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