One therapy with many attributes

POTENT DIFLUORINATED STEROID

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

EMULSION FORMULATION FOR DOSE CONSISTENCY^1,10

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

Study Design

Percent variation in concentration of active drug dispensed

In clinical studies of cataract surgery patients

Proven to help clear inflammation and resolve ocular pain¹

Study Design

ZERO INFLAMMATION IN NEARLY 3X MORE PATIENTS VERSUS PLACEBO^1,11

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

ZERO PAIN IN NEARLY 2X AS MANY PATIENTS VERSUS PLACEBO^1,11

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

Study Design

Mean change from baseline in AC cell grade¹³

Study treatment-related ocular adverse events for patients with endogenous anterior uveitis^13,14

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 2^14,15

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

Study Design

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 1^13,15
5 patients (8.9%) in the DUREZOL® Emulsion group and 2 patients (3.7%) in the prednisolone acetate group in Study 2^13,15

Study Design

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.

INDICATIONS AND USAGE

DUREZOL® (difluprednate ophthalmic emulsion) 0.05% is a topical corticosteroid that is indicated for:

The treatment of inflammation and pain associated with ocular surgery.
The treatment of endogenous anterior uveitis.

Dosage and Administration

For the treatment of inflammation and pain associated with ocular surgery instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response.
For the treatment of endogenous anterior uveitis, install one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.

IMPORTANT SAFETY INFORMATION

Contraindications

DUREZOL® Emulsion, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Warnings and Precautions

Intraocular pressure (IOP) increase – Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored.
Cataracts – Use of corticosteroids may result in posterior subcapsular cataract formation.
Delayed healing – The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
Bacterial infections – Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
Viral infections – Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Fungal infections – Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.
Contact lens wear – DUREZOL® Emulsion should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of DUREZOL® Emulsion. The preservative in DUREZOL® Emulsion may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of DUREZOL® Emulsion.

Most Common Adverse Reactions

In postoperative ocular inflammation and pain studies, ocular adverse reactions occurring in 5-15% of subjects included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.
In the endogenous anterior uveitis studies, the most common adverse reactions occurring in 5-10% of subjects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis.

For additional information about DUREZOL® Emulsion, please see full Prescribing Information.

References: 1. Durezol [package insert]. Fort Worth, TX: Alcon Laboratories, Inc; April 2017. 2. US Food and Drug Administration. Orange book: approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl-Type=N&Appl_No=022212. Updated October 2015. Accessed December 15, 2015. 3. Alrex [package insert]. Bridgewater, NJ: Bausch & Lomb Inc; 2016. 4. FML [package insert]. Irvine, CA: Allergan Inc; 2013. 5. Lotemax Gel [package insert]. Bridgewater, NJ: Bausch & Lomb Inc; 2016. 6. Lotemax Suspension [package insert]. Bridgewater, NJ: Bausch & Lomb Inc; 2016. 7. Maxidex [package insert]. Fort Worth, TX: Alcon Laboratories Inc; 2002. 8. Pred Forte [package insert]. Irvine, CA: Allergan Inc; 2017. 9. Vexol [package insert]. Fort Worth, TX: Alcon Laboratories Inc; 2012. 10. Stringer W, Bryant R. Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%. Clin Ophthalmol. 2010;4:1119-1124. 11. Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS; Difluprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group. Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. J Cataract Refract Surg. 2009;35(1):26-34. 12. Data on file. 13. Foster CS, DaVanzo R, Flynn TE, McLeod K, Vogel R, Crockett RS. Durezol® (difluprednate ophthalmic emulsion 0.05%) compared with Pred Forte® 1% ophthalmic suspension in the treatment of endogenous anterior uveitis. J Ocul Pharmacol Ther. 2010;26(5):475-483. 14. Sheppard JD, Toyos MM, Kempen JH, Kaur P, Foster CS. Difluprednate 0.05% versus prednisolone acetate 1% for endogenous anterior uveitis: a phase III, multicenter, randomized study. Invest Ophthalmol Vis Sci. 2014;55(5):2993-3002. 15. Data on file.

INDICATIONS AND USAGE

DUREZOL® (difluprednate ophthalmic emulsion) 0.05% is a topical corticosteroid that is indicated for:

The treatment of inflammation and pain associated with ocular surgery.
The treatment of endogenous anterior uveitis.

Dosage and Administration

For the treatment of inflammation and pain associated with ocular surgery instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response.
For the treatment of endogenous anterior uveitis, install one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Intraocular pressure (IOP) increase – Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored.
Cataracts – Use of corticosteroids may result in posterior subcapsular cataract formation.
Delayed healing – The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
Bacterial infections – Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
Viral infections – Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Fungal infections – Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.
Contact lens wear – DUREZOL® Emulsion should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of DUREZOL® Emulsion. The preservative in DUREZOL® Emulsion may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of DUREZOL® Emulsion.

Most Common Adverse Reactions

In postoperative ocular inflammation and pain studies, ocular adverse reactions occurring in 5-15% of subjects included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.
In the endogenous anterior uveitis studies, the most common adverse reactions occurring in 5-10% of subjects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis.

For additional information about DUREZOL® Emulsion, please see full Prescribing Information.

FORMULATED FOR POTENCY

The only FDA-approved difluorinated ophthalmic steroid^1-9

One therapy with many attributes

POTENT DIFLUORINATED STEROID

EMULSION FORMULATION FOR DOSE CONSISTENCY^1,10

BAK-FREE TOPICAL OPHTHALMIC STEROID

CONSISTENT DRUG DELIVERY¹⁰

In clinical studies of cataract surgery patients

Proven to help clear inflammation and resolve ocular pain¹

ZERO INFLAMMATION IN NEARLY 3X MORE PATIENTS VERSUS PLACEBO^1,11

ZERO PAIN IN NEARLY 2X AS MANY PATIENTS VERSUS PLACEBO^1,11

Help resolve inflammation in patients with endogenous anterior uveitis

Study treatment-related ocular adverse events for patients with endogenous anterior uveitis^13,14

Study 1¹³

Study 2^14,15

Safety profile for patients based on ocular surgery clinical trials

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

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

for a 5.0 ml bottle

Your patients will:

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

INDICATIONS AND USAGE

Dosage and Administration

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Most Common Adverse Reactions

INDICATIONS AND USAGE

Dosage and Administration

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Most Common Adverse Reactions

FORMULATED FOR POTENCY

The only FDA-approved difluorinated ophthalmic steroid1-9

One therapy with many attributes

POTENT DIFLUORINATED STEROID

EMULSION FORMULATION FOR DOSE CONSISTENCY1,10

BAK-FREE TOPICAL OPHTHALMIC STEROID

CONSISTENT DRUG DELIVERY10

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

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

Help resolve inflammation in patients with endogenous anterior uveitis

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

Study 113

Study 214,15

Safety profile for patients based on ocular surgery clinical trials

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

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

for a 5.0 ml bottle

Your patients will:

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

INDICATIONS AND USAGE

Dosage and Administration

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Most Common Adverse Reactions

INDICATIONS AND USAGE

Dosage and Administration

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Most Common Adverse Reactions

The only FDA-approved difluorinated ophthalmic steroid^1-9

EMULSION FORMULATION FOR DOSE CONSISTENCY^1,10

CONSISTENT DRUG DELIVERY¹⁰

Proven to help clear inflammation and resolve ocular pain¹

ZERO INFLAMMATION IN NEARLY 3X MORE PATIENTS VERSUS PLACEBO^1,11

ZERO PAIN IN NEARLY 2X AS MANY PATIENTS VERSUS PLACEBO^1,11

Study treatment-related ocular adverse events for patients with endogenous anterior uveitis^13,14

Study 1¹³

Study 2^14,15

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

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