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3 Feb 2015

USFDA grants approval of Pazeo(TM) (olopatadine hydrochloride ophthalmic solution) 0.7%

— Developed with efficacy data at 24 hours, post dose, to provide one-drop daily ocular itch relief associated with allergic conjunctivitis (eye allergies)

— Up to 30% of the U.S. population is affected by seasonal allergy symptoms, with as many as 70 to 80% of these demonstrating ocular symptoms such as itching

Alcon, the global leader in eye care and a division of Novartis, has received approval from the US Food and Drug Administration (FDA) of Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7%, for the treatment of ocular itching associated with allergic conjunctivitis. Pazeo solution is dosed one drop daily, and was approved with efficacy data at 24 hours, post dose.

“Pazeo solution represents an important addition to our ocular allergy portfolio in the United States,” said Sabri Markabi, Senior Vice President, Research & Development for Alcon. “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.”

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

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(R) 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.

“Allergic conjunctivitis (eye allergies) can be a 24-hour-a-day burden for patients suffering from those symptoms,” said Eric Donnenfeld, MD, founding partner of Ophthalmic Consultants of Long Island and clinical professor of ophthalmology at New York University. “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.”

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.

About Allergic Conjunctivitis

Allergic conjunctivitis is more commonly referred to as eye allergies and affects the conjunctiva, which is the clear layer of skin overlying the eyes. Eye allergies are not typically harmful to a person’s eyes or vision; however, they can cause discomfort. The most common subtypes of allergic conjunctivitis are seasonal allergic conjunctivitis, which lasts for a short period of time, and perennial allergic conjunctivitis, a chronic, year-round condition.


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