Vernal keratoconjunctivitis: Result of a novel therapy with 0.1% topical ophthalmic FK-506 ointment

Abstract

Rationale Severe cases of VKC often do not readily respond to currently available treatment. We conducted an open-label trial with 0.1% ophthalmic FK-506 ointment to determine its efficacy in VKC. Methods Ten recalcitrant cases of VKC were enrolled. There were 9 boys and 1 girl (mean ages ± SD=9.12 ± 2.45 years). Their duration of VKC was 3.97 ± 1.96 years. CBC, renal and liver functions were obtained at baseline and at the end of treatment. Complete physical and ophthalmologic examination was undertaken at baseline and at weekly interval. FK506 ointment was applied, once to twice daily, for 4 weeks. Eye symptoms and side effect were recorded daily. Blood levels of FK506 were determined after 4 weeks of use. Results Rapid resolution of eye symptoms was observed. Mean symptoms score at the end of the first week reaching 31% of baseline-mean (p=0.015) and at the end of the therapy (4th) was 20% of baseline-mean. Mild eye stinging was noted (7 patients). There was a significant reduction of size of tarsal papilla (from a mean ± SD of 1.09 ± 0.64 mm at the beginning to 0.63 ± 0.57 mm at 4 weeks, p<0.01). Blood FK506 levels at the end of the therapy were low in all patients. Laboratory results were all normal. Both patients and physician rated high preference for the treatment. Conclusion FK506 is a highly effective treatment in this study. A study with longer treatment duration and with a comparison to other drugs is warranted.