Alcon has received FDA approval for 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, according to a company news release.
Results from two clinical studies (Conjunctival Allergen Challenge) 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% (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.
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.
“Pazeo solution represents an important addition to our ocular allergy portfolio in the United States,” Sabri Markabi, Senior Vice President, Research and Development for Alcon, said in the news release. “Patients who experience itching due to allergic conjunctivitis 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 US population is affected by seasonal allergy symptoms, and up to 70% to 80% of these demonstrate ocular symptoms such as itchy eyes, according to Alcon.