The Role of 0.03% Topical Tacrolimus as an Immunomodulatory Agent in High-Risk Keratoplasty

Authors

  • María Andrea Estévez Flórez Servicio de Oftalmología. Facultad de Medicina, Universidad El Bosque, Bogotá, Colombia.
  • Fernando Yaacov Peña Servicio de Oftalmología. Facultad de Medicina, Universidad El Bosque, Bogotá, Colombia.
  • Fernando Augusto Godin Estrada Servicio de Oftalmología. Facultad de Medicina, Universidad El Bosque, Bogotá, Colombia.

DOI:

https://doi.org/10.70313/2718.7446.v18.n4.465

Keywords:

tacrolimus, keratoplasty, graft rejection, cornea, immunosuppression

Abstract

Objective: To evaluate the clinical outcomes of using 0.03% topical tacrolimus as an immunomodulatory agent in patients undergoing high-risk keratoplasty.

Methods: A descriptive, retrospective observational case series study was conducted between May and December 2024 at the Clínica Oftalmológica Colsubsidio (Bogotá, Colombia). The tacrolimus used was a compounding preparation (ILAB Laboratory). Patients with high-risk corneal transplants were included, treated with topical tacrolimus concomitant with 1% prednisolone acetate. Immunological rejection rate, best corrected visual acuity (BCVA), adverse effects, and therapeutic adherence were analyzed. Descriptive bivariate analyses was used to explore associations between clinical variables and outcomes.

Results: Fifteen cases were included. The mean BCVA showed a clinically significant improvement, from 1.98±0.32 logMAR preoperatively to 0.57±0.20 logMAR postoperatively. Adequate adherence to the treatment was 80.0%. The survival of the corneal grafts was 66.7%. It was determined that 60.0% of the total rejection episodes were directly associated with a lack of adherence. Adverse effects such as burning and foreign body sensation were mild and transient, presenting in 40.0% of the cases, with no severe events documented.

Conclusions: 0.03% topical tacrolimus was associated with significant visual recovery in patients with high-risk corneal transplants. The 66.7% graft survival in this very high-risk cohort and the excellent safety profile reinforce its value as an immunosuppressive strategy that mitigates the risk of graft failure. Prospective controlled studies with a larger sample size are required to robustly confirm these findings at a regional level.

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Author Biographies

  • María Andrea Estévez Flórez, Servicio de Oftalmología. Facultad de Medicina, Universidad El Bosque, Bogotá, Colombia.
    • Médica cirujana, Residente de Oftalmología.

    • Especialización en Oftalmología, Facultad de Medicina, Universidad El Bosque, Bogotá, Colombia.

    • Correo: mestevezf@unbosque.edu.co

    • ORCID: 0000-0002-3341-9073

  • Fernando Yaacov Peña, Servicio de Oftalmología. Facultad de Medicina, Universidad El Bosque, Bogotá, Colombia.
    • Oftalmólogo, Especialista en cirugía refractiva, Asesor metodológico y epedemiologico

    • Profesor de Epidemiología, Universidad El Bosque, Bogotá, Colombia.

    • Correo: fpenam@unbosque.edu.co

    • ORCID: 0000-0002-4336-8636

  • Fernando Augusto Godin Estrada, Servicio de Oftalmología. Facultad de Medicina, Universidad El Bosque, Bogotá, Colombia.
    • Médico cirujano, Especialista en oftalmología, Subespecialidad en Córnea y cirugía refractiva, Asesor temático

    • Profesor de Córnea, Universidad El Bosque, Bogotá, Colombia.

    • Correo: drfernandogodine@gmail.com

    • ORCID: 0000-0001-8540-5784

References

1. Gain P, Jullienne R, He Z et al. Global survey of corneal transplantation and eye banking. JAMA Ophthalmol 2016; 134(2): 167-173. doi:10.1001/jamaophthalmol.2015.4776.

2. Abud TB, Di Zazzo A, Kheirkhah A, Dana R. Systemic immunomodulatory strategies in high-risk corneal transplantation. J Ophthalmic Vis Res 2017; 12(1): 81-92. doi:10.4103/2008-322X.200156.

3. Hashemian MN, Latifi G, Ghaffari R et al. topical tacrolimus as adjuvant therapy to corticosteroids in acute endothelial graft rejection after penetrating keratoplasty: a randomized controlled trial. Cornea 2018; 37(3): 307-312. doi:10.1097/ICO.0000000000001408.

4. Amouzegar A, Chauhan SK. Effector and regulatory T cell trafficking in corneal allograft rejection. Mediators Inflamm 2017; 2017: 8670280. doi:10.1155/2017/8670280.

5. Di Zazzo A, Kheirkhah A, Abud TB, Goyal S, Dana R. Management of high-risk corneal transplantation. Surv Ophthalmol 2017; 62(6): 816-827. doi:10.1016/j.survophthal.2016.12.010.

6. Sakowska J, Glasner P, Zieliński M, Trzonkowski P, Glasner L. Corneal allografts: factors for and against acceptance. J Immunol Res 2021; 2021: 5372090. doi:10.1155/2021/5372090.

7. Jabbehdari S, Rafii AB, Yazdanpanah G, Hamrah P, Holland EJ, Djalilian AR. Update on the management of high-risk penetrating keratoplasty. Curr Ophthalmol Rep 2017; 5(1): 38-48. doi:10.1007/s40135-017-0119-2.

8. Asma MA, Reinisch CB, Holland EJ, Cheung AY. (2022). Immunosuppressive therapy for high-risk corneal transplant. Curr Ophthalmol Rep 2022; 10: 114-129. doi:10. 10.1007/s40135-022-00298-0.

9. Zhai LY, Zhang XR, Liu H, Ma Y, Xu HC. Observation of topical tacrolimus on high-risk penetrating keratoplasty patients: a randomized clinical trial study. Eye (Lond) 2020; 34(9): 1600-1607. doi:10.1038/s41433-019-0717-3.

10. Tamura K, Fujimura T, Iwasaki K et al. Interaction of tacrolimus (FK506) and its metabolites with FKBP and calcineurin. Biochem Biophys Res Commun 1994; 202(1): 437-443. doi:10.1006/bbrc.1994.1947.

11. Geba GP, Ptak W, Askenase PW. Topical tacrolimus and cyclosporin A differentially inhibit early and late effector phases of cutaneous delayed-type and immunoglobulin E hypersensitivity. Immunology 2001; 104(2): 235-242. doi:10.1046/j.1365-2567.2001.01288.x.

12. Panda A, Vanathi M, Kumar A, Dash Y, Priya S. Corneal graft rejection. Surv Ophthalmol 2007; 52(4): 375-396. doi:10.1016/j.survophthal.2007.04.008.

13. Shaw KT, Ho AM, Raghavan A et al. Immunosuppressive drugs prevent a rapid dephosphorylation of transcription factor NFAT1 in stimulated immune cells. Proc Natl Acad Sci U S A 1995; 92(24): 11205-11209. doi:10.1073/pnas.92.24.11205.

14. Sawada S, Suzuki G, Kawase Y, Takaku F. Novel immunosuppressive agent, FK506. In vitro effects on the cloned T cell activation. J Immunol 1987; 139(6): 1797-1803.

15. Bernardes L, Gil J, Costa E et al. Topical tacrolimus in high-risk corneal transplants. Eur J Ophthalmol 2024; 34(1): 140-145. doi:10.1177/11206721231172236.

16. Tahmaz V, Gehlsen U, Sauerbier L et al. Treatment of severe chronic ocular graft-versus-host disease using 100% autologous serum eye drops from a sealed manufacturing system: a retrospective cohort study. Br J Ophthalmol 2017; 101(3): 322-326. doi:10.1136/bjophthalmol-2015-307666.

17. Joseph MA, Kaufman HE, Insler M. Topical tacrolimus ointment for treatment of refractory anterior segment inflammatory disorders. Cornea 2005; 24(4): 417-420. doi:10.1097/01.ico.0000151507.49565.6e.

18. Bohm K, Djalilian AR. Topical tacrolimus use in inflammatory ocular surface diseases. Invest Ophthalmol Vis Sci 2019; 60(9): 252.

19. Irfan S, Ahmed A, Rasheed F. To assess the efficacy and safety of tacrolimus skin cream, 0.03% in moderate to severe vernal keratoconjunctivitis. Pakistan J Ophthalmol 2015; 31(1): 15-21.

20. Birnbaum F, Reis A, Reinhard T. Long term use of topical tacrolimus (FK506) in high-risk penetrating keratoplasty. Cornea 2009; 28(6): 715-716. doi:10.1097/ico.0b013e318199fa8c.

21. Magalhaes OA, Marinho DR, Kwitko S. Topical 0.03% tacrolimus preventing rejection in high-risk corneal transplantation: a cohort study. Br J Ophthalmol 2013; 97(11): 1395-1398. doi:10.1136/bjophthalmol-2013-303639.

22. Faramarzi A, Abbasi H, Feizi S et al. Topical 0.03% tacrolimus versus systemic mycophenolate mofetil as adjuncts to systemic corticosteroids for preventing graft rejection after repeat keratoplasty: one-year results of a randomized clinical trial. Eye (Lond) 2021; 35(10): 2879-2888. doi:10.1038/s41433-020-01375-z.

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Published

2025-12-22

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Section

Original Articles

How to Cite

1.
Estévez Flórez MA, Yaacov Peña F, Godin Estrada FA. The Role of 0.03% Topical Tacrolimus as an Immunomodulatory Agent in High-Risk Keratoplasty. Oftalmol. Clín. Exp. 2025;18(4):e443-e451. doi:10.70313/2718.7446.v18.n4.465

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