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Management of inflammation in dry eye disease: recommendations from a European panel of experts1

Ikervis® (ciclosporin 1 mg/mL) is indicated for treatment of severe keratitis in adults with dry eye disease (DED), which has not improved despite treatment with tear substitutes.2

Elisabeth M Messmer, Sajjad Ahmad, José M Benitez del Castillo, Ewa Mrukwa-Kominek, Maurizio Rolando, Oksana Vitovska and Christophe Baudouin on behalf of a panel of European dry eye disease experts. Eur J Ophthalmol 2023;33(3):1294–13071

Applying the pan-European Dry Eye Disease consensus in practice

Click on the symbol throughout to see the percentage of experts that agreed with each statement.
  • When should I initiate treatment with Ikervis® (ciclosporin 1 mg/mL)?

    1. Initial treatment: stepwise approach

    Patients with moderate corneal staining:

    2. Starting treatment with CsA

    Criteria for treatment initiation
    In the presence of key clinical risk factors for severe DED: consider early initiation
    Absence of severe corneal staining* should not prevent initiation of CsA in patients with other clinical risk factors
  • What factors should I consider when treating a patient with Ikervis® (ciclosporin 1 mg/mL)?

    3. CsA and adjunct therapies

    Key adjunct therapies: ATs and corticosteroids

    Apply ATs regularly during the day, ideally 15 minutes before and/or after CsA

    Bridging CsA with corticosteroids can be used to offset the relatively fast onset of the anti-inflammatory effect of a topical steroid and the relatively slow onset of the anti-inflammatory effect of CsA.

    Adapted from Messmer E M et al, 20231

    CsA can be initiated together with a corticosteroid or up to 1 week later

    4. CsA adherence

    Patient and clinician education are critical to improving compliance with CsA treatment.

    5. Efficacy and side-effect profile

    Main indicators of efficacy include reduction in blurred vision, reduced ocular surface staining and improved tear-film
break-up time.

    Some patients may need to stop treatment due to an AE, but education and management could help reduce treatment discontinuation rates.

    Summary of CsA side effects:

    The most common adverse reactions are eye pain (19.0%), eye irritation (17.5%), ocular hyperaemia (5.5%), lacrimation increased (4.9%) and eyelid erythema (1.7%) which are usually transitory and occurred during instillation. These adverse reactions are consistent with those that have been reported during post-marketing experience.

    UK: Prescribing information
    IE: Prescribing information

    CsA: cyclosporin A; TEAE: treatment-emergent adverse event
    References: 12. Leonardi A et al. Eur J Ophthalmol 2016;26:287-296; 13. Chen D et al. Medicine (Baltimore) 2019;98:e16710; 14. Park C H et al. Korean J Ophthalmol 2019;33:343-352; 15. Wirta D L et al. Ophthalmology 2019;126:792-800; 19. Baudouin C et al. Eur J Ophthalmol 2017;27:678-685

  • When should I stop treatment with Ikervis?

    6. Assessing patients receiving CsA

    Patients should ideally be examined within 3 months after treatment initiation

    7. When to stop treatment with CsA

    CsA can be continued indefinitely if tolerated, effective and the patient is happy.

    No need to stop CsA if the patient needs surgery

    Risk of relapse may be lower in patients who are treated for a longer period versus those treated for a shorter period.17†

    †Based on a comparison in which the ‘longer period’ group received treatment for 6 months longer than the ‘shorter period’ group.17

ATs: artificial tears; CsA: ciclosporin A

References:
  1. Messmer E M, Ahmad S et al. Management of inflammation in dry eye disease: recommendations from a European panel of experts. Eur J Ophthalmol 2023;33:1294-1307
  2. Ikervis Summary of Product Characteristics. Available at: medicines.org.uk. Accessed Augst 2024
  3. Epitropoulos A T, Therattil A et al. Improving tolerance and compliance with topical immunomodulators using
micro-emulsion lipid layer artificial tears. Clin Ophthalmol 2020;14:1921-1929
  4. Mah F, Milner M et al. PERSIST: Physician’s Evaluation of Restasis® Satisfaction in Second Trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective review. Clin Ophthalmol 2012;6:1971-1976
  5. Gehlsen U, Siebelmann S, Steven P. Tolerance and adherence to cationic 0.1% cyclosporine in ocular graft-versus-host disease. Ophthalmic Res 2021;64:77-84
  6. Hind J, Macdonald E, Lockington D. Real-world experience at a Scottish university teaching hospital regarding the tolerability and persistence with topical ciclosporin 0.1% (Ikervis) treatment in patients with dry eye disease. Eye (Lond) 2019;33:685-686
  7. Aragona P, Giannaccare G et al. Modern approach to the treatment of dry eye, a complex multifactorial disease: a P.I.C.A.S.S.O. board review. Br J Ophthalmol 2021;105:446-453
  8. White D E, Zhao Y et al. Physician satisfaction with anti-inflammatory topical medications for the treatment of dry eye disease. Clin Ophthalmol 2020;14:931-938
  9. White D E, Zhao Y et al. Treatment satisfaction among patients using anti-inflammatory topical medications for dry eye disease. Clin Ophthalmol 2020;14:875-883
  10. Abstractband DOG 2018. Ophthalmologe 2018;115:1-194
  11. Pleyer U, Geerling G et al. If artificial tears aren’t enough. The importance of inflammatory processes in dry eye disease. Practical aspects of an anti-inflammatory therapy of dry eye disease. Klin Monbl Augenheilkd 2020;237:655-668
  12. Leonardi A, Van Setten G et al. Efficacy and safety of 0.1% cyclosporine A cationic emulsion in the treatment of severe dry eye disease: a multicenter randomized trial. Eur J Ophthalmol 2016;26:287-296
  13. Chen D, Zhang S et al. Efficacy and safety of 0.05% cyclosporine ophthalmic emulsion in treatment of Chinese patients with moderate to severe dry eye disease: a 12-week, multicenter, randomized, double-masked, placebo-controlled phase III clinical study. Medicine (Baltimore) 2019;98:e16710
  14. Park C H, Kim M K et al. Efficacy of topical cyclosporine nanoemulsion 0.05% compared with topical cyclosporine emulsion 0.05% and diquafosol 3% in dry eye. Korean J Ophthalmol 2019;33:343-352
  15. Wirta D L, Torkildsen G L et al. A clinical phase II study to assess efficacy, safety, and tolerability of waterfree cyclosporine formulation for treatment of dry eye disease. Ophthalmology 2019;126:792-800
  16. Geerling G, Hamada S et al. Real-world effectiveness, tolerability and safety of cyclosporine A 0.1% cationic emulsion in severe keratitis and dry eye treatment. Ophthalmol Ther 2022;11:1101-1117
  17. Labetoulle M, Leonardi A et al. Persistence of efficacy of 0.1% cyclosporin A cationic emulsion in subjects with severe keratitis due to dry eye disease: a nonrandomized, open-label extension of the SANSIKA study. Clin Ther 2018;40:1894-1906
  18. Jones L, Downie L E et al. TFOS DEWS II management and therapy report. Ocul Surf 2017;15:575-628
  19. Baudouin C, de la Maza M S et al. One-year efficacy and safety of 0.1% cyclosporine A cationic emulsion in the treatment of severe dry eye disease. Eur J Ophthalmol 2017;27:678-685

Request further information

A steering committee formed of seven European DED experts developed a questionnaire to gather information on clinical practice. The outcomes from the questionnaire were used to develop 18 relevant recommendation statements for consensus voting. The committee plus 22 European experts then voted on each statement using a 9-point scale (1 = strongly disagree and 9 = strongly agree). Statements scored with a 7, 8 or 9 by ≥75% of the panel were classified as reaching consensus.1

DED: dry eye disease
Reference: 1. Messmer E M et al. Eur J Ophthalmol 2023;33:1294-1307

The corticosteroid may be tapered off in accordance with changes in the signs and symptoms of inflammation.1

Typical approach: reduce steroid dose by one drop every 7-14 days

Reference: 1. Messmer E M et al. Eur J Ophthalmol 2023;33:1294-1307

Common reasons for CsA non-compliance:

*May be market dependent.

UK: Prescribing information
IE: Prescribing information

AE: adverse event; CsA: cyclosporin A; DED: dry eye disease
References: 1. Messmer E M et al. Eur J Ophthalmol 2023;33:1294-1307; 3. Epitropoulos A T et al. Clin Ophthalmol 2020;14:1921-1929; 4. Mah F et al. Clin Ophthalmol 2012;6:1971-1976; 5. Gehlsen U et al. Ophthalmic Res 2021;64:77-84; 6. Hind J et al. Eye (Lond) 2019;33:685-686; 7. Aragona P et al. Br J Ophthalmol 2021;105:446-453; 8. White D E et al. Clin Ophthalmol 2020;14:875-883; 9. White D E et al. Clin Ophthalmol 2020;14:931-938

Managing CsA-associated discomfort:

UK: Prescribing information
IE: Prescribing information

ATs: artificial tears; CsA: cyclosporin A
References: 1. Messmer E M et al. Eur J Ophthalmol 2023;33:1294-1307; 2. Ikervis SPC; 10. Abstractband DOG 2018. Ophthalmologe 2018;115:1-194; 11. Pleyer U et al. Klin Monbl Augenheilkd 2020;237:655-668

Efficacy of CsA:

UK: Prescribing information
IE: Prescribing information

CsA: cyclosporin A; DED: dry eye disease
References: 1. Messmer E M et al. Eur J Ophthalmol 2023;33:1294-1307; 12. Leonardi A et al. Eur J Ophthalmol 2016;26:287-296; 13. Chen D et al. Medicine (Baltimore) 2019;98:e16710; 14. Park C H et al. Korean J Ophthalmol 2019;33:343-352; 15. Wirta D L et al. Ophthalmology 2019;126:792-800; 16. Geerling G et al. Ophthalmol Ther 2022;11:1101-1117; 17. Labetoulle M et al. Clin Ther 2018;40:1894-1906; 18. Jones L et al. Ocul Surf 2017;15:575-628

Consensus

86.2%

Consensus

93.1%

Consensus

89.7%

Consensus

79.3%

Consensus

89.7%

Consensus

86.2%

Consensus

89.7%

Consensus

96.6%

Consensus

86.2%

Consensus

96.6%

Consensus

93.1%

Consensus

89.7%

Consensus

93.1%

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