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In clinical studies of ocular surgery patients, Study Design: Two randomized, double-masked, placebo-controlled trials evaluated the e cacy of DUREZOL® Emulsion QID (n=107) versus placebo QID (n=220) in patients with an anterior chamber cell count ≥11 one day after cataract surgery; P<0.05. 2 ZERO Infl ammation in nearly 3x more patients at days 8 and 15 2 • 22% versus 8% on day 8 • 41% versus 12% on day 15 ZERO Pain in nearly 2x more patients at days 3, 8, and 15 2 • 45% versus 25% on day 3 • 58% versus 27% on day 8 • 63% versus 35% on day 15 Study Design: Two randomized, double-masked, placebo-controlled trials evaluated the e cacy of DUREZOL® Emulsion QID (n=107) versus placebo QID (n=220) in patients with an anterior chamber cell count ≥11 one day after cataract surgery; P<0.05. P<0.05. P • 41% versus 12% on day 15 • 58% versus 27% on day 8 • 63% versus 35% on day 15 © 2017 Novartis 5/17 DZL-1343556 INDICATIONS AND USAGE DUREZOL® (difl uprednate ophthalmic emulsion) 0.05% is a topical corticosteroid that is indicated for: •The treatment of infl ammation and pain associated with ocular surgery. • The treatment of endogenous anterior uveitis. Dosage and Administration • For the treatment of infl ammation and pain associated with ocular surgery instill one drop into the conjunctival sac of the a• ected eye 4 times daily beginning 24 hours after surgery and continuing throughout the fi rst 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, instill one drop into the conjunctival sac of the a• ected 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 fi elds 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 magnifi cation such as slit lamp biomicroscopy and, where appropriate, fl uorescein 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 infl ammation and pain studies, ocular adverse reactions occurring in 5-15% of subjects included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacifi cation, anterior chamber cells, anterior chamber fl are, 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 Brief Summary of Prescribing Information on adjacent page. References: 1. Data on fi le. IMS SMART MVP solutions. Novartis Pharmaceuticals Corp; Oct 2016. 2. Durezol [package insert]. Fort Worth, TX: Alcon Laboratories, Inc; 2016. 3. Fingertip Formulary, January 2017 (estimate derived from information used under license from Fingertip Formulary, LLC, which expressly reserves all rights, including rights of copying, distribution and republication). 4. Data on fi le. Study ST-601A-002a. Novartis Pharmaceuticals Corp; 2007. 5. Data on fi le. Study ST-601A-002b. Novartis Pharmaceuticals Corp; 2007. DUREZOL ® (difl uprednate ophthalmic emulsion) 0.05% is a potent and e• ective ocular steroid that has been prescribed for millions of patients. 1,2 When prescribing a steroid to treat infl ammation and pain associated with ocular surgery and for the treatment of endogenous anterior uveitis, One therapy for many eyes How could DUREZOL ® Emulsion help more of your patients? with Commercial and Medicare Part D plans 3 < $ 47 Average Co-Pay *Eligibility terms and conditions apply. Please see co-pay savings materials for details. Evaluation of Pain: Using a validated and well-characterized method, symptoms of pain and discomfort were collected at each visit and graded 0 to 100 according to a visual analogue scale that used a mark on a 100-mm line (with anchor points of 0=absent and 100=maximal pain or discomfort). 4,5 Eligible Commercial patients may pay as little as $ 35 *

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