PAZEO® Solution efficacy: RAPID RELIEF AT ONSET THAT LASTS 24 HOURS1

Statistically significantly improved ocular itch relief compared with vehicle at onset of action (30-34 minutes)1

Mean 24-hour ocular allergy itching scores at 3, 5, and 7 minutes postconjunctival allergen challenge (CAC), respectively1:

Study 1

PAZEO® Solution: 0.36, 0.53, 0.48

PATADAY® Solution (olopatadine hydrochloride ophthalmic solution) 0.2%: 0.39, 0.61, 0.61

Vehicle: 1.90, 2.06, 1.97

Study 2

PAZEO® Solution: 0.38, 0.53, 0.65

PATADAY® Solution: 0.47, 0.61, 0.61

Vehicle: 1.91, 1.99, 1.82

P<.05 vs PAZEO® Solution2,3

The first CAC was at 27 (±1) minutes posttreatment instillation to assess onset of action of PAZEO® Solution.4,5

Mean (+/- SE) Post-CAC Ocular Itching Scores at 30-34 Minutes Post Dose1,6

The first conjunctival antigen challenge (CAC) was at 27 (±1) minutes posttreatment instillation to assess onset of action of PAZEO® Solution. Itching score data were collected 3, 5, and 7 minutes after antigen instillation. Graphs present overall mean ocular itching scores averaged over all post-CAC time points.4,5

  PAZEO® Solution demonstrated statistically significantly improved ocular itch relief compared with vehicle at onset of action1

Two multicenter, randomized, double-masked, parallel-group, vehicle- and active-controlled studies in patients at least 18 years of age with allergic conjunctivitis using the conjunctival allergen challenge (CAC) model (N=547). Patients were randomized to receive study drug or vehicle, 1 drop per eye on each 2-3 assessment days. On separate days, antigen challenge was performed at 27 (±1) minutes post dose to assess onset of action, at 16 hours post dose (Study 1 only), and at 24 hours post dose. Itching scores were evaluated using a half-unit scale from 0=none to 4=incapacitating itch, with data collected 3, 5, and 7 minutes after antigen instillation. The primary objectives were to demonstrate the superiority of PAZEO® Solution for the treatment of ocular allergy itch. Study 1: PAZEO® Solution vs vehicle at onset of action and 16 hours. Study 2: PAZEO® Solution vs vehicle at onset of action; PAZEO® Solution vs PATADAY® Solution, PATANOL® (olopatadine hydrochloride ophthalmic solution) 0.1%, and vehicle at 24 hours.1,4,5


PAZEO® SOLUTION: THE ONLY FDA-APPROVED THERAPY WITH DEMONSTRATED 24-HOUR OCULAR ALLERGY ITCH RELIEF IN ONE DROP1

Statistically significant reduction in ocular allergy itching at 24 hours1

Mean 24-hour ocular allergy itching scores at 3, 5, and 7 minutes postconjunctival allergen challenge (CAC), respectively1:

Study 1

PAZEO® Solution: 0.93, 1.10, 1.09

PATADAY® Solution: 1.41, 1.52, 1.50

Vehicle: 2.54, 2.62, 2.50

Study 2

PAZEO® Solution: 1.01, 1.22, 1.25

PATADAY® Solution: 1.33, 1.48, 1.41

Vehicle: 2.30, 2.37, 2.14

P<.05 vs PAZEO® Solution2,3

Mean (+/- SE) Post-CAC Ocular Itching Scores at 24 Hours1,6

Itching score data were collected 3, 5, and 7 minutes after antigen instillation. Graphs present overall mean ocular itching scores averaged over all post-CAC time points.4,5

  PAZEO® Solution demonstrated statistically significantly improved relief of ocular itching compared with PATADAY® Solution at 24 hours post dose (not statistically significantly different at 30-34 minutes)1

Two multicenter, randomized, double-masked, parallel-group, vehicle- and active-controlled studies in patients at least 18 years of age with allergic conjunctivitis using the conjunctival allergen challenge (CAC) model (N=547). Patients were randomized to receive study drug or vehicle, 1 drop per eye on each 2-3 assessment days. On separate days, antigen challenge was performed at 27 (±1) minutes post dose to assess onset of action, at 16 hours post dose (Study 1 only), and at 24 hours post dose. Itching scores were evaluated using a half-unit scale from 0=none to 4=incapacitating itch, with data collected 3, 5, and 7 minutes after antigen instillation. The primary objectives were to demonstrate the superiority of PAZEO® Solution for the treatment of ocular allergy itch. Study 1: PAZEO® Solution vs vehicle at onset of action and 16 hours. Study 2: PAZEO® Solution vs vehicle at onset of action; PAZEO® Solution vs PATADAY® Solution, PATANOL® (olopatadine hydrochloride ophthalmic solution) 0.1%, and vehicle at 24 hours.1,4,5

INDICATION AND DOSING

PAZEO® Solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis. The recommended dosage is to instill one drop in each affected eye once a day. 

IMPORTANT SAFETY INFORMATION

As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to prevent contaminating the tip and solution. Keep bottle tightly closed when not in use. 

Patients should not wear a contact lens if their eye is red. PAZEO® Solution should not be used to treat contact lens-related irritation. The preservative in PAZEO® Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least five minutes after instilling PAZEO® Solution before they insert their contact lenses. 

The most commonly reported adverse reactions in a clinical study occurred in 2%-5% of patients treated with either PAZEO® Solution or vehicle. These events were blurred vision, dry eye, superficial punctate keratitis, dysgeusia, and abnormal sensation in eye. 

For additional information on PAZEO® Solution, please click here to view the full Prescribing Information.

*Terms and Conditions:

Limitations apply. For commercially insured patients. Up to a $125 cap per bottle. Patient will be responsible for any co-pay once limit per bottle is reached. This offer is not valid under Medicare, Medicaid, or any other federal or state program. Not valid for cash-paying patients. Novartis reserves the right to rescind, revoke, or amend this program without notice. Offer expires 12/31/2017.

References: 1. PAZEO®  [package insert.] Fort Worth, TX: Alcon Laboratories, Inc; 2016. 2. Torkildsen R, Narvekar A, Bergmann M. Efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis using a conjunctival allergen-challenge model. Clin Ophthalmol. 2015;9:1703-1713. 3. McLauren E, Narvekar A, Gomes P, Adewale A, Torkildsen G. Phase 3 randomized double-masked study of efficacy and safety of once-daily 0.77% olopatadine hydrochloride ophthalmic solution in subjects with allergic conjunctivitis using the conjunctival allergen challenge model. Cornea. 2015;34(10):1245-1251. 4. Data on file, 2011. 5. Data on file, 2013. 6. Data on file, 2014.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION & DOSING

PAZEO®Solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis. The recommended dosage is to instill one drop in each affected eye once a day. 

IMPORTANT SAFETY INFORMATION

As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to prevent contaminating the tip and solution. Keep bottle tightly closed when not in use. 

Patients should not wear a contact lens if their eye is red. PAZEO® Solution should not be used to treat contact lens-related irritation. The preservative in PAZEO®Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least five minutes after instilling PAZEO® Solution before they insert their contact lenses. 

The most commonly reported adverse reactions in a clinical study occurred in 2%-5% of patients treated with either PAZEO®Solution or vehicle. These events were blurred vision, dry eye, superficial punctate keratitis, dysgeusia, and abnormal sensation in eye. 

For additional information on PAZEO® Solution, please click here to view the full Prescribing Information.

*Terms and Conditions:

Limitations apply. For commercially insured patients. Up to a $125 cap per bottle. Patient will be responsible for any co-pay once limit per bottle is reached. This offer is not valid under Medicare, Medicaid, or any other federal or state program. Not valid for cash-paying patients. Novartis reserves the right to rescind, revoke, or amend this program without notice. Offer expires 12/31/2017.

References: 1. PAZEO®  [package insert.] Fort Worth, TX: Alcon Laboratories, Inc; 2016. 2. Torkildsen R, Narvekar A, Bergmann M. Efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis using a conjunctival allergen-challenge model. Clin Ophthalmol. 2015;9:1703-1713. 3. McLauren E, Narvekar A, Gomes P, Adewale A, Torkildsen G. Phase 3 randomized double-masked study of efficacy and safety of once-daily 0.77% olopatadine hydrochloride ophthalmic solution in subjects with allergic conjunctivitis using the conjunctival allergen challenge model. Cornea. 2015;34(10):1245-1251. 4. Data on file, 2011. 5. Data on file, 2013. 6. Data on file, 2014.