FDA Approves Pazeo™ Solution for Ocular Allergy

By: Ankur Dave Pharm D.

The FDA recently approved Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7% for ocular itching associated with allergic conjunctivitis. Pazeo was created by Alcon, the global leader in eye care and a division of Novartis Pharmaceuticals. The solution can be taken once a day with proven efficacy data at 24 hours post dose.

Results from two Conjunctival Allergen Challenge clinical studies, showed that Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7%, demonstrated statistically significantly improved relief of ocular itching associated with allergic conjunctivitis at 24 hours post-treatment compared to olopatadine 0.2% (known as Pataday® solution). The safety profile of Pazeo solution is comparable to that of olopatadine 0.2%. In the two clinical studies, the most common adverse reactions occurred in 2 to 5% of patients treated with either Pazeo solution or a vehicle. These events were blurred vision, dry eye, superficial punctate keratitis, dysgeusia, and abnormal sensation in the eye.

As much as 30% of the US population is affected by seasonal allergy symptoms, with as many as 70-80% of these people showing ocular symptoms such as itching. Allergic conjunctivitis, more commonly referred to as eye allergies, affects the conjunctiva, which is the clear layer of skin overlying the eyes. Although eye allergies are not typically harmful to person’s eye and vision they can be a 24-hour-a-day burden. “Patients now have an available option that can provide ocular itch relief with efficacy demonstrated at 24 hours. This approval represents an exciting new option in ocular allergy itch relief therapy,” says Eric Donnenfeld, MD founding partner of Ophthalmic Consultants of Long Island and Clinical Professor of Ophthalmology at NYU.

As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to prevent contaminating the tip and solution, keeping the bottle tightly closed when not in use. The preservative in Pazeo solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients should be instructed to wait at least five minutes after instilling Pazeo solution before they insert their contact lenses. Pazeo solution is anticipated to be available by prescription in the United States in March 2015, followed by Latin American and Asian markets through 2017.

http://www.novartis.com/newsroom/media-releases/en/2015/1890563.shtml