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Topical FK506 as an Immuno-prophylaxis after Allogenic Penetrating Normal-risk Keratoplasty: A Prospective Randomized Clinical Trial

1Mayweg S., 1Reinhard T., 1Reis A., 2Oberhuber H., 2Mathis G., 1Sundmacher R.,
1Heinrich-Heine-Universität Düsseldorf, Universitäts-Augenklinik (Düsseldorf)
2SUCAMPO-Pharma Schweiz (Zürich)

Background: Topical steroids represent an effective prophylaxis of immune reactions after allogeneic normal-risk keratoplasty. Due to severe side-effects, however, their administration is limited to some months postoperatively. FK506 inhibits transcription of IL-2 in a similar manner as Cyclosporin A, but immunosuppressive potential of FK506 is about 100 times higher. Futhermore, FK506 penetrates more easily into the cornea. Here, first results of a randomised clinical trial in normal-risk keratoplasty patients are presented.
Patients: Forty patients were randomised into the study. All patients received 1mg/kg bodyweight/day of systemic fluocortolon tapered within 3 weeks postoperatively. Twenty patients were treated with FK506 0.06% 3x/day for 6 months postoperatively. Further 20 patients received 5 drops of prednisolone acetete 1% tapered within 6 months. Current follow up is 7.5±3.0 months.
Results: Nine months postoperatively all patients of the FK 506 group were free from immune reactions, in contrast to 84% in the steroid group (Kaplan Meier values; p=0.9 in the log-rank-test). None of the patients developed irreversible graft failure so far. In 8 patients of the FK506 group premature withdrawal of the drug was necessary due to side-effects (mostly burning).
Conclusions: FK506 might turn out to become an effective immunoprophylaxis in normal-risk keratoplasty patients. Local discomfort, however, must be further reduced in the future.