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Impressum
FK506 - A new dimension in topical immunomodulation. The Duesseldorf Compassionate Use Trial
1Reis A., 2Mathis G., 1Mayweg S., 1Reinhard T., 1Sundmacher R.
1Eye Hospital, Heinrich-Heine University, Düsseldorf; 2SUCAMPO-Pharma, Schweiz
Background: Until now efficient topical immunosuppression can
only be achieved with topical steroids. Already in clinical trials but
still not clinically approved is the IL-inhibitor cyclosporin A (CSA).
Although efficient, this agent comes a long with a high number of therapeutic
failures. FK 506 is a macrolid-immunosuppressiv agent with similar mode
of action but with a 100-fold higher efficacy. This is the first time
that FK506 is available in a stable formulation as eye drops.
Case reports: Nine patients have been treated. All of them were
classified as CSA treatment failures (lack of response, relapse of original
disease, allergy). The original diseases have been: severe atopic conjunctivitis
(4), graft versus host disease (1), steroid response-glaucoma following
keratoplasty (1), Thygeson-keratitis (1), persisting nummuli following
epidemic keratoconjunctivitis (1), Mooren´s ulcer (1). FK506 (0,06%)
has been applied 3 times daily. The mean follow-up/treatment period was
three months (1-4 months).
Results: We have seen a significant improvement of symptoms and
vision in four patients with severe atopic conjunctivitis within two weeks
of treatment. Likewise a significant improvement in the patients with
Thygeson-keratitis and persisting nummuli has been seen. In two other
patients a stabilisation of the progressive disease has been established.
We had to discontinue FK506 treatment in one patient due to conjunctival
chemosis after the first application.
Discussion: For the first time the immunosuppressive macrolid FK506
is available in a stable formulation as eye drops. The first efficacy
and safety data in a selected population (all patients have been CSA-failures)
showed very promising results. The value and safety of this topical immunomodulating
agent in the treatment of ocular immunologic disorders has to be investigated
in controlled clinical trials.