A proprietary formulation of ketotifen fumarate ophthalmic solution 0.025% (Alaway, Bausch &Lomb) offers a highly safe and effective treatment for allergic conjunctivitis with the convenience benefits of an OTC medication.
When first introduced as a legend drug for the treatment of allergic conjunctivitis in 1999, Dr. Slonim said, ketotifen fumarate was the second prescription agent on the market within the class of dual-acting antihistamine/mast cell stabilizers. In addition, it controls the itching of allergy by acting through other pathways important in the inflammatory cascade, he added. Ketotifen fumarate has been shown to reduce eosinophil chemotaxis, Dr. Slonim said.
"This added activity contributes to make ketotifen fumarate an effective agent for relieving itchy eyes associated with ocular allergy. It was a good therapeutic choice when available by prescription only and remains a good choice as an OTC product," he said. "Considering its established safety track record with no risks of serious ocular or systemic harm, the decision to seek OTC status for this product was a good one."
The opportunity to purchase ketotifen fumarate without a prescription has benefits for patients and physicians, Dr. Slonim said. Patients who know they have allergic conjunctivitis and those who call a doctor's office describing their signs and symptoms may acquire the product without having to come in for an appointment. That feature saves time and money for patients and allows busy practitioners to schedule patients who require more urgent medical attention.
"There are also some patients who are convinced they will not achieve an adequate response to any OTC treatment and prefer to schedule an appointment. Once told that ketotifen fumarate was formerly sold by prescription only, they may be more willing to give the OTC agent a try," he added.
Although several other ocular antihistamines are available as OTC products, ketotifen fumarate provides much longer-lasting activity, Dr. Slonim said. It acts quickly and can relieve itching for up to 12 hours, he added, whereas other OTC antihistamines generally are recommended to be administered four times a day. In addition, Dr. Slonim said, ketotifen fumarate is approved for use in children aged as few as 3 years.
When to schedule
Patients whose symptoms fail to respond adequately to a trial of OTC ketotifen fumarate can be prescribed, a non-OTC topical ophthalmic product of the same drug class, such as azelastine hydrochloride (Optivar, MedPointe), epinastine hydrochloride (Elestat, Allergan), or olopatadine hydrochloride (Pataday, Alcon Laboratories). Patients who are experiencing signs and symptoms that suggest a diagnosis other than allergic conjunctivitis should be scheduled for an appointment.
"Red eye has a broad differential diagnosis that includes serious infectious and non-infectious conditions that may be sight-threatening. Persistent red eye, blurred vision, or sudden loss of vision raise red flags. Patients with those findings should be seen for evaluation," he said.