Therapeutic effects of tacrolimus ointment for refractory ocular surface inflammatory diseases

Purpose: To investigate the therapeutic effects of topical tacrolimus ointment on refractory ocular surface inflammatory diseases. Design: Retrospective interventional consecutive case series. Participants: Ten consecutive patients with severe ocular surface inflammatory diseases who were suspected to be steroid responders (elevation of intraocular pressure [IOP]) or were refractory to standard steroid therapy were studied. One patient had peripheral ulcerative keratitis with impending corneal perforation, 1 had a Mooren's ulcer, 2 had scleroperikeratitis, 5 had atopic keratoconjunctivitis, and 1 had vernal keratoconjunctivitis. Methods: The clinical findings and therapeutic responses after treatment with 0.02% topical tacrolimus ointment were determined by conventional ophthalmological examinations. Main Outcome Measures: Resolution of the ocular surface diseases (e.g., decrease of hyperemia, ulceration, size of papillae) and IOP. The necessity to use steroids was also assessed. Results: In all cases, marked to moderate improvement was obtained, including suppression of the melting reaction of the inflamed cornea, remission of scleroperikeratitis, and reduction of a giant papilla and corneal epithelial defect in severe atopic keratoconjunctivitis. The elevated IOP was reduced in steroid responders after successful cessation of steroid therapy. No adverse side effect was noted for 2 to 26 months of continuous treatment. Conclusions: Topical tacrolimus ointment is effective in treating refractory ocular surface inflammatory diseases and should be considered as an alternative to higher doses, steroid supplementation, or surgical intervention.