Tacrolimus 0.01% was effective for the treatment of vernal keratoconjunctivitis in a study with 62 patients.
Take-home message: Tacrolimus 0.01% was effective for the treatment of vernal keratoconjunctivitis in a study with 62 patients.
By Vanessa Caceres; Reviewed by Samir Shoughy, MD, FRCS (Glasg.)
Riyadh, Saudi Arabia-A low dose of topical tacrolimus was a safe and effective treatment for vernal keratoconjunctivitis (VKC) in a recent study, said Samir Shoughy, MD, FRCS (Glasg.).
Vernal keratoconjunctivitis is a leading cause of outpatient ophthalmic morbidity, said Dr. Shoughy, The Eye Center and The Eye Foundation for Research in Ophthalmology, Riyadh, Saudi Arabia.
“If not properly treated, it can lead to scarring, microbial keratitis, limbal tissue hyperplasia, amblyopia, and dry eye syndrome,” he said.
VKC is more common in dry and hot climates and in children or young adults with an atopic background. More males than females have VKC.
Typical treatment for VKC includes antihistamines, mast cell stabilizers, vasoconstrictors, corticosteroids, and immunomodulators, Dr. Shoughy said.
“Corticosteroids are an important line of treatment but are associated with complications like increased IOP and cataract formation,” he said. “We are in need of more safe and effective drugs.”
Tacrolimus is a macrolide antibiotic that is 10 to 100 times more potent than cyclosporine, he explained.
The drug suppresses T-cell activation, T helper cell-mediated B-cell proliferation, and cytokine formation.
Dr. Shoughy shared results from a study of 62 patients with refractory VKC. Patients-who ranged in age from 5 to 47 years old (mean age, 18 years)-had symptoms and signs of VKC even though they had used conventional medications. VKC was diagnosed by itching, redness, foreign body sensation, and discharge.
Researchers excluded patients with known hypersensitivity to tacrolimus, infectious eye disease, those who were pregnant, and those on systemic therapy for other allergic diseases.
Clinical symptoms were graded as normal (0), mild (1+), moderate (2+), or severe (3+). Researchers assessed patients before tacrolimus treatment began and at one month after treatment.
Tacrolimus eye drops were reconstituted at Dr. Shoughy’s center in a sterile environment by adding balanced salt solution to the contents of a tacrolimus capsule, to achieve a dose of 0.01%. Patients used the solution twice a day for a month.
Itching improved in 82% of patients, redness improved in 75%, discharge reduced in 84%, and foreign body sensation reduced in 77%. All percentages were based on the actual number of patients experiencing a symptom, not the full study group.
The improved signs included conjunctival hyperemia, limbal infiltrates, Trantas dots, and superficial punctate keratitis. Papillary hypertrophy also improved but to a lesser degree compared with the other signs.
Five percent (three patients) experienced side effects from the treatment. Two felt a burning sensation, and one felt irritation.
When asked why such a low percentage of patients had side effects compared with others’ use of tacrolimus, Dr. Shoughy said it was likely because the study dose was particularly low.
“We use one-tenth of the concentration used in most trials,” he said.
Dr. Shoughy also reported that a maintenance dose of 0.01% could be used by patients. He and study researchers have prescribed this dose safely for once daily or once every other day.
He also said that he uses tacrolimus as a first-line therapy, without the use of steroids. After one week of therapy, he typically sees 70% to 80% of the needed response in patients, and itching usually resolves in 2 to 3 days after patients begin to use it.
Samir Shoughy, MD, FRCS (Glasg.)
This article was adapted from Dr. Shoughy’s presentation at the 2014 meeting of the American Academy of Ophthalmology. Dr. Shoughy did not indicate any proprietary interest in the subject matter.