FDA approves Alcon's Pazeo for ocular allergy itch relief

The US Food and Drug Administration has approved Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7% from Alcon, the eyecare division of Swiss drug major Novartis (NOVN: VX), for ocular itching in allergic conjunctivitis.

It was approved on the basis of efficacy data at 24 hours post-dose. Results from two Conjunctival Allergen studies showed Pazeo statistically significant improved relief of ocular itching associated with allergic conjunctivitis at 24 hours post-treatment compared to olopatadine 0.2%. The safety profile of Pazeo was comparable to olopatadine (known as Patadaysolution) and the most common adverse reactions such as blurred vision, dry eye and dysegeusia occurred in 2%-5% of patients.

Sabri Markabi, senior vice president of R&D at Alcon, said: "Pazeo solution represents an important addition to our ocular allergy portfolio in the United States. 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."