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FDA approves anti-allergy agent from Alcon
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The U.S. Food and Drug Administration has granted U.S. marketing approval to Pazeo, a solution for ocular allergy itch relief from Alcon.
Pazeo (olopatadine HCl ophthalmic solution) 0.7% is a once-daily drop designed to relieve itching related to allergic conjunctivitis for 24 hours, according to a press release from Alcon.
The company reported that two conjunctival allergen challenge clinical studies showed that Pazeo demonstrated “statistically significantly improved relief of ocular itching associated with allergic conjunctivitis at 24 hours post-treatment” compared to Pataday (olopatadine 0.2%, Alcon).
Alcon noted that the safety profile of the two agents is comparable, with the most common adverse reactions – blurred vision, dry eye, superficial punctate keratitis, dysgeusia and abnormal sensation – occurring in 2% to 5% of patients treated with either Pazeo or the vehicle.
“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,” Sabri Markabi, senior vice president, research and development for Alcon, said in the release.
Alcon said it anticipates Pazeo to be available by prescription in the U.S. in March 2015, followed by Latin American and Asian markets through 2017.