Bepostastine found to be safe in children, study says

October 15, 2009

Twice-daily dosing of bepostastine besilate ophthalmic solution 1.5% was found to be safe, with minimal adverse events, in a randomized, double-masked, 6-week safety study including two groups of healthy pediatric patients.

Havre de Grace, MD-Twice-daily dosing of bepotastine besilate ophthalmic solution 1.5% (Bepreve, ISTA Pharmaceuticals) was found to be safe, with minimal adverse events, in a randomized, double-masked, 6-week safety study including two groups of healthy pediatric patients, aged 3 to 9 years and 10 to 17 years, respectively, according to Eugene E. Protzko, MD. He is in private practice in Havre de Grace, MD, and is a member of the Bepotastine Ophthalmic Solutions Study Group.

The study findings are important, Dr. Protzko said, because "particularly when we're talking about a pediatric population, a medicine that is uncomfortable or stings is a drop that's going to be very difficult to use. A child under the age of 12 would rather have itchy, swollen eyes than take something that causes their eyes to sting, although older children may be more tolerant."

The children comprised about 15% of all (861) patients participating in the safety study. Of the 55 patients aged 10 to 17 years, 40 were randomly assigned to receive bepotastine, and 15 were randomly assigned to receive placebo. Of the 72 children aged 3 to 9 years, 47 were randomly assigned to receive bepotastine, and 25 were randomly assigned to receive placebo.

Adverse events

No serious adverse events were reported, and no pediatric patients withdrew from the study for any reason. The frequency of adverse events was similar in those children who instilled bepotastine (14.9%) and those who were randomly assigned to receive placebo (12.5%). Dr. Protzko said that he considered all of the adverse events among those receiving the active drug to be mild.

Most of the adverse events in the pediatric patients were non-ocular. Only one ocular adverse event was reported in the bepotastine group, and two children in the placebo group reported an ocular adverse event, according to Dr. Protzko.

In the group of children aged 10 to 17 years, adverse events in the bepotastine study arm included six reports of bad taste on instillation (15%) and one report each of punctate keratitis (2.5%) and headache (2.5%).

In the corresponding group of older children taking the placebo, one case each of eye irritation (6.7%) and eye pruritus (6.7%) was reported. Both cases were considered to be related to the test drug. One adverse event report of a contusion was not considered to be related to the test agent.

The adverse events in the children aged 3 to 9 years included four instances of bad taste on instillation in the bepotastine group (8.5%)-all considered related to drug treatment-and one case of gastroesophageal reflux disease, or GERD (2.1%). The GERD adverse event was considered to be unrelated to the study medication. Two events occurred in the placebo group (a urinary tract infection and a limb injury, both considered to be unrelated to test agent).

Other similarities

In addition to the similarities in rates of adverse events between the two treatment groups of pediatric patients, Dr. Protzko found no difference in IOP (p > 0.65), visual acuity (p > 0.73), or comfort (p > 0.48) in the children aged 10 to 17 years. These factors were not evaluated in the group of younger children.

"Most patients weight the comfort and safety of a medication against its efficacy. If you have a very efficacious medication but it's uncomfortable, it may impact compliance and the proper use of the drug in conditions like allergic conjunctivitis," he said. "In the pediatric population, the eye-drop medication needs to be well-tolerated and comfortable. We found bepotastine . . . to meet that standard."

One of the noteworthy findings, Dr. Protzko said, was that several of the patients in both active treatment study groups reported that they could taste the medicine. The nature of these remarks was more of a comment than a complaint about the flavor, he added. Dr. Protzko also mentioned that the informed consent included taste as a possible side effect of the medication, so the subjects' remarks with regard to taste could have been the result of the power of suggestion.

In September, the FDA approved bepotastine as a twice-daily prescription eye-drop treatment for ocular itching associated with allergic conjunctivitis in patients aged 2 or more years.