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FDA Approves Pazeo (Olopatadine) Solution for Ocular Allergy Itch Relief

Product launch expected in March

The FDA has approved Pazeo (olopatadine hydrochloride ophthalmic solution 0.7%, Alcon) for the treatment of ocular itching associated with allergic conjunctivitis. The solution is dosed one drop daily and was approved with efficacy data at 24 hours post-dose.

Up to 30% of the U.S. population is affected by seasonal allergy symptoms, and up to 70% to 80% of these individuals experience ocular symptoms, such as itchy eyes.

Results from two clinical studies showed that olopatadine hydrochloride ophthalmic solution 0.7%, provided significantly improved relief of ocular itching associated with allergic conjunctivitis at 24 hours post-treatment compared with olopatadine 0.2% (Pataday solution, Alcon). The safety profile of the olopatadine 0.7% solution was comparable with that of olopatadine 0.2%. In the two studies, the most common adverse events included blurred vision, dry eye, superficial punctate keratitis, dysgeusia, and abnormal sensations in the eye.

Pazeo solution 0.7% is expected to be available by prescription in the U.S. in March 2015.

Allergic conjunctivitis is not typically harmful to a person’s eyes or vision; however, it can cause discomfort. The most common subtypes of allergic conjunctivitis are seasonal allergic conjunctivitis, which lasts for a short period, and perennial allergic conjunctivitis, a chronic, year-round condition.

Source: Alcon; February 2, 2015.

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