Pazeo™ (olopatadine) — New Drug Approval - Professionals ...

[Pages:1]PazeoTM (olopatadine) -- New Drug Approval ? On February 2, 2015, Novartis and Alcon announced the FDA approval of Pazeo (olopatadine

0.7%) ophthalmic solution, for the treatment of ocular itching associated with allergic conjunctivitis. ? Allergic conjunctivitis is a condition affecting the conjunctiva, the clear layer of skin overlying the

eyes. While not typically harmful to the individual's eyes or vision, allergic conjunctivitis can cause discomfort. Characteristic symptoms include itching or burning eyes, tearing eyes, puffy eyelids, red eyes, or eye discharge. ? Pazeo contains olopatadine, an ocular antihistamine and mast cell stabilizer that targets histamine-1 receptors and inhibits histamine release from mast cells.

-- Other ophthalmic solutions containing olopatadine include Pataday? (olopatadine 0.2%) and Patanol? (olopatadine 0.1%). Pataday and Patanol are currently brand-only products.

-- Olopatadine nasal spray is also generically available under the name, Patanase?. ? The safety and efficacy of Pazeo were based on two clinical trials comparing Pazeo to Pataday and

vehicle ophthalmic solutions. -- Pazeo demonstrated statistically significant improvement in ocular itching compared to vehicle at 30 ? 34 minutes, 16 hours, and 24 hours after study treatment. -- Pazeo also demonstrated statistically significant improvement in ocular itching compared to Pataday at 24 hours after study treatment, but not at 30 ? 34 minutes after study treatment.

? Warnings and precautions of Pazeo include contamination of tip and solution, and contact lens use. -- Pazeo contains the preservative, benzalkonium chloride, which may be absorbed by soft contact lenses. Patients should not wear a contact lens if their eye is red.

? The most common adverse events (2% ? 5%) with Pazeo use were blurred vision, superficial punctate keratitis, dry eye, abnormal sensation in eye, and dysgeusia.

? The recommended dose of Pazeo is 1 drop to each affected eye once daily. ? Alcon plans to launch Pazeo in March 2015. Pazeo will be available as a 0.7% ophthalmic solution,

containing 7.76 mg of olopatadine hydrochloride in 1 mL of solution.

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