Pharmaceutical Business review

FDA approves Alcon’s Pazeo Solution for ocular allergy itch relief

The company said that Pazeo solution is dosed one drop daily, and was approved with efficacy data at 24 hours, post dose.

The approval was based on data from two Conjunctival Allergen Challenge clinical trials, which showed that Pazeo improved relief of ocular itching associated with allergic conjunctivitis at 24 hours post-treatment compared to olopatadine 0.2% (known as Pataday solution).

Alcon Research & Development senior vice-president Sabri Markabi said: "Pazeo solution represents an important addition to our ocular allergy portfolio in the US.

"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."

In these trials, blurred vision, dry eye, superficial punctate keratitis, dysgeusia and abnormal sensation in the eye were the most common adverse reactions occurred in 2% to 5% of patients treated with either Pazeo solution or a vehicle.

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

"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."

In the US, Pazeo solution will be made available by prescription in March 2015, followed by Latin American and Asian markets through 2017.