Tacrolimus Eye Drops Associated With Improvement of Refractory Allergic Ocular Diseases

By Will Boggs MD

April 22, 2014

NEW YORK (Reuters Health) - Use of tacrolimus 0.1% eye drops is associated with significant improvement of refractory allergic conjunctivitis with proliferative lesions and/or corneal involvement, according to an observational study from Japan.

Developed as an immunosuppressant for use following organ transplant, tacrolimus in ointment form has been found useful for treating refractory inflammatory disease of the outer ocular area. Unfortunately, these ointments can also cause irritation and epithelial keratitis, Dr. Atsuki Fukushima from Kochi Medical School and colleagues write in the British Journal of Ophthalmology, online April 2.

The team prospectively evaluated data from 1,436 patients who had received the eye drops after responding poorly to conventional agents, including antiallergic ophthalmic solutions, topical steroids and/or cyclosporine.

Patients received one drop of tacrolimus twice daily and were observed for up to six months. The mean total score of clinical signs decreased from 15.3 (out of 30) at the start of treatment to 5.9 at the last observation, and the mean total clinical symptom score decreased from 8.1 (out of 18) at baseline to 1.8 at the last observation.

Nearly two-thirds of patients had active-stage giant papillae at baseline; this number dropped to 15.8% at the time of the last observation. The prevalence of superficial punctate keratopathy also fell from 67.8% of patients to 22.3% of patients.

Results were similar for the subset of patients who were switched from cyclosporine eye drops to tacrolimus eye drops.

More than half the patients (53.4%) were successfully weaned off topical steroids six months into tacrolimus treatment.

The only major adverse reaction was a transient burning sensation after the drops were administered. Three patients experienced elevation of intraocular pressure that the researchers attributed to adjunctive topical steroid use.

Despite the fact that the study was observational, the authors venture that tacrolimus eye drops "may reduce or replace topical steroid use."

Dr. Pakit Vichyanond from Faculty of Medicine Siriraj Hospital in Bangkok, Thailand, who was not involved in the study, said his institution already uses tacrolimus in patients with vernal keratoconjunctivitis.

"It is another very effective drug for allergic eyes not responding to regular treatments," Dr. Vichyanond told Reuters Health by email. "Perhaps steroids should be used first to induce disease remission and then maintained with tacrolimus at decreased interval -- perhaps once a day or even three times a week -- similar to in atopic dermatitis in recalcitrant cases."

"Tacrolimus is very expensive," Dr. Vichyanond added. "My hope is to have the drug available to the public at cheaper price. The drug has been on the market for some time, and the cost should come down. Now we are talking about techniques to disperse it into suspension/emulsion phase to sell. I am sure that other pharmaceuticals will follow suit, and we will be able to distribute the drug more widely at lower cost."

The new study was funded by Senju Pharmaceutical Co., Osaka, Japan. None of the authors reported additional conflicts of interest.

Dr. Fukushima did not respond to a request for comments.

SOURCE: http://bit.ly/1r4DGjo

Br J Ophthalmol 2014.

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