Therapeutic effect of 0.1% Tacrolimus Eye Ointment in Allergic Ocular Diseases.

INTRODUCTION: Allergic Ocular Diseases (AODs) like Atopic Keratoconjunctivitis (AKC) and Vernal Keratoconjunctivitis (VKC) are chronic forms of ocular allergy that can cause severe visual complications. Pathogenesis of AODs is uncertain and treatment has been a challenge for ophthalmologists. Tacrolimus, a 23-member cyclic macrolide lactone derived from [streptomyces tsukubaensis] now in ointment form has been successfully used in AODs.

AIM: To study the therapeutic effect of 0.1% Tacrolimus eye ointment in patients with Allergic Ocular Diseases (AODs).

MATERIALS AND METHODS: This prospective observational study was conducted on 36 patients with severe AOD and moderate cases not responding to conventional treatment. They were treated with 0.1% tacrolimus eye ointment twice daily for minimum three months in addition to conventional treatment and observed for a period of 6 months. Symptoms and signs after treatment were evaluated. Grades of clinical signs were assessed based on slit lamp clinical photographs; development of possible complications was assessed and analysed by Wilcoxon signed rank test.

RESULTS: Mean age of patients was 9.3±4.3 years and mean duration of AODs was 3.1±1.8 years. The scores on both the four point scales for signs and symptoms decreased significantly (p<0.0001) after 1 month of 0.1% Tacrolimus eye ointment treatment. Itching was the first symptom to show dramatic relief and conjunctival hyperaemia was the first sign to show improvement. 88.88% of patients were successfully weaned off topical steroids in 6 months into Tacrolimus treatment. Even in patients unresponsive to 0.1% topical Cyclosporine, symptoms and signs scores decreased significantly (p<0.0001). The most common adverse reaction was a transient burning sensation (36.11%).

CONCLUSION: Topical 0.1% Tacrolimus eye ointment was found to be a safe and effective treatment in cases of AODs and also worked as steroid sparing and replacing agent. It was also found effective in patient's refractory to topical Cyclosporine.