One therapy with many attributes

POTENT DIFLUORINATED STEROID

With fluorination at the C-6 and C-9 positions1

EMULSION FORMULATION FOR DOSE CONSISTENCY1,10

The only topical ophthalmic steroid formulated as an emulsion, and with proprietary DROP-TAINER® technology1

BAK-FREE TOPICAL OPHTHALMIC STEROID

Preserved with sorbic acid1

CONSISTENT DRUG DELIVERY10

Regardless of bottle orientation or shaking, all DUREZOL® Emulsion concentrations at each time point analyzed were within 15% of declared concentration.10

Percent variation in concentration of active drug dispensed

In clinical studies of cataract surgery patients

Proven to help clear inflammation and resolve ocular pain1

ZERO INFLAMMATION IN NEARLY 3X MORE PATIENTS VERSUS PLACEBO1,11

Percentage of patients with anterior chamber cells clearing (cell count=0)


ZERO PAIN IN NEARLY 2X AS MANY PATIENTS VERSUS PLACEBO1,11

Percentage of patients who were pain free

Help resolve inflammation in patients with endogenous anterior uveitis

For the noninferiority analysis, the upper 95% CL on the difference in mean change from baseline in AC cell grade was required to be <0.5 units. The difference was less than the noninferiority margin at all time points after Day 3.13

Mean change from baseline in AC cell grade13

Study treatment-related ocular adverse events for patients with endogenous anterior uveitis13,14

Study 113

Adverse Event

DUREZOL® Emulsion
n=50 n(%)

Pred Forte* Suspension
n=40 n(%)

Punctate keratitis

8 (16.0)

5 (12.5)

Vision blurred

4 (8.0)

0 (0.0)

Iridocyclitis

Eye irritation

5 (10.0)

1 (2.5)

Dry eye

3 (6.0)

0 (0.0)

IOP increase

6 (12.0)

2 (5.0)

Study 214,15

Adverse Event

DUREZOL® Emulsion
n=56 n(%)

Pred Forte* Suspension
n=54 n(%)

Punctate keratitis

3 (5.4)

0 (0.0)

Vision blurred

1 (1.8)

0 (0.0)

Iridocyclitis

3 (5.4)

2 (3.7)

Eye irritation

1 (1.8)

0 (0.0)

Dry eye

IOP increase

5 (8.9)

2 (3.7)

*Trademark is the property of its owner.

IOP increases that were reported as an adverse event (which may not have been captured as a “clinically significant IOP rise,” or one that was ≥21 mmHg and change from baseline ≥ 10 mmHg at the same visit).

Safety profile for patients based on ocular surgery clinical trials

Study treatment-related ocular adverse events occurring in more than 2% of patients.1,11

CONJUNCTIVAL HYPEREMIA

DUREZOL®
Emulsion, 4x daily

4.5%

Placebo
 

19.5%

CILIARY HYPEREMIA

DUREZOL®
Emulsion, 4x daily

4.5%

Placebo
 

17.3%

ANTERIOR CHAMBER CELL

DUREZOL®
Emulsion, 4x daily

3.6%

Placebo
 

11.8%

CONJUNCTIVAL EDEMA

DUREZOL®
Emulsion, 4x daily

3.6%

Placebo
 

6.4%

EYE INFLAMMATION

DUREZOL®
Emulsion, 4x daily

1.8%

Placebo
 

3.6%

PHOTOPHOBIA

DUREZOL®
Emulsion, 4x daily

3.6%

Placebo
 

5.5%

PUNCTATE KERATITIS

DUREZOL®
Emulsion, 4x daily

3.6%

Placebo
 

2.7%

ANTERIOR CHAMBER FLARE

DUREZOL®
Emulsion, 4x daily

0.9%

Placebo
 

7.3%

IRITIS

DUREZOL®
Emulsion, 4x daily

2.7%

Placebo
 

0.5%

VISUAL ACUITY REDUCED

DUREZOL®
Emulsion, 4x daily

4.5%

Placebo
 

8.6%

EYE PAIN

DUREZOL®
Emulsion, 4x daily

5.4%

Placebo
 

5.0%

FOREIGN BODY SENSATION

DUREZOL®
Emulsion, 4x daily

0.9%

Placebo
 

4.1%

CORNEAL EDEMA

DUREZOL®
Emulsion, 4x daily

2.7%

Placebo
 

8.2%

In clinical trials of ocular surgery, the mean IOP in patients receiving DUREZOL® Emulsion did not significantly change and remained in the normal range in all treatment groups11

A clinically significant IOP rise (≥21 mmHg; ≥10 mmHg from baseline) was observed in 3 patients (3%) in the DUREZOL® Emulsion QID group and in 2 patients (1%) in the placebo group.11

When DUREZOL® Emulsion is used for 10 days or longer, IOP should be monitored.1

One patient in the DUREZOL® Emulsion groups and both patients in the placebo group required lOP-lowering medication.11

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve and defects in visual acuity and fields of vision. 1

ST-601A-002a and ST-601A-002b

Clinical trial: IOP range11


Observed IOP increase in clinical trials of EAU:

  • 6 patients (12%) in the DUREZOL® Emulsion group and 2 patients (5%) in the prednisolone acetate group in Study 113,15
  • 5 patients (8.9%) in the DUREZOL® Emulsion group and 2 patients (3.7%) in the prednisolone acetate group in Study 213,15

Proportion of patients with a single-visit change in IOP of ≥10 mmHg from baseline and an observed value of ≥21 mmHg

ST-601A-002a and ST-601A-002b

Clinical trial: IOP Change–DUREZOL® Emulsion vs. Pred Forte*

DUREZOL® Emulsion 4x daily (Study 1): n=50
Pred Forte* Suspension 8x daily (Study 1): n=40
DUREZOL® Emulsion 4x daily (Study 2): n=56
Pred Forte* Suspension 8x daily (Study 2): n=54

*Trademark is the property of its owner.

MyChoiceRx Offers EVERY Patient One
Set Price for DUREZOL® Emulsion, Every Time


$60

for a 5.0 ml bottle

Your patients will:

  • Receive the medication you prescribe.
  • Not have to spend time trying to figure out their prescription coverage.
  • Be able to pick up at any one of the 54,000+ participating pharmacies.

To learn the full details of MyChoiceRx™ and how it can benefit your patients, please visit MyChoiceRx.com or call 1-866-747-4276.

* Valid prescription required. Purchases through the Program may not be counted toward patient deductible or out-of-pocket costs. Patients with federal or state-funded prescription plans (i) may not seek reimbursement from their plan for Program purchases, (ii) must notify plan of participation through provided form letter, and (iii) must not use their plan benefits for the remainder of the calendar year for any subsequent purchase of the Novartis product purchased through the Program. Program is not insurance. Patient is responsible for complying with applicable requirements of their plan. Valid only in the United States and Puerto Rico. Limitations may apply in CA and MA. Void where prohibited by law. Novartis reserves the right to rescind, revoke, or amend Program without notice. If you have any questions pertaining to the MyChoiceRx program, including questions regarding the transmission of a claim, reimbursement, or about patient eligibility, please e-mail ScriptHero at help@scripthero.com.