FDA approves drug for ocular allergy itch relief

February 4, 2015

FDA has approved olopatadine hydrochloride ophthalmic solution (Pazeo, Alcon, a division of Novartis) 0.7% for the treatment of ocular itch relief related to eye allergies.

FDA has approved olopatadine hydrochloride ophthalmic solution (Pazeo, Alcon, a division of Novartis) 0.7% for the treatment of ocular itch relief related to eye allergies.

Pazeo is a 1-drop daily ocular itch relief product for allergic conjunctivitis.

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According to the American College of Allergy, Asthma & Immunology, as many as 30% of adults and 40% of children suffer from allergic rhinitis (hay fever); 70% to 80% of those have ocular symptoms like itchy eyes. Eye allergies affect the conjunctiva, the clear layer of skin overlapping the eyes, and generally cause discomfort for individuals.

Pazeo’s approval was based on 2 Conjunctival Allergen Challenge clinical studies that showed that Pazeo 0.7%, demonstrated statistically significantly improved relief of ocular itching associated with allergic conjunctivitis at 24 hours post-treatment compared to olopatadine 0.2% (Pataday solution. The safety profile of Pazeo solution is comparable to that of olopatadine 0.2%.

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The most common adverse reactions seen in participants in the 2 clinical studies were blurred vision, dry eye, superficial punctate keratitis, dysgeusia and abnormal sensation in the eye.

"Patients who experience itching due to allergic conjunctivitis (eye allergies), will now be able to turn to a one-drop daily product with efficacy data 24 hours after dosing,” said Sabri Markabi, senior vice president, research & development for Alcon in a press release.

Pazeo is expected to be available by prescription in the United States in March 2015. It will be available in Asian and Latin American markets in 2017.

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