Eyeworld

3 EW NEWS & OPINION ASCRS releases position statement on 2 established ophthalmic practices August 2015 The ASCRS Cataract Clinical Committee strongly supports the current established practice T he American Society of Cat- aract & Refractive Surgery (ASCRS) has released an official position statement opposing directives that restrict 2 well-established presurgi- cal ophthalmic practices: the use of diluted povidone-iodine solution for topical infection prophylaxis and the use of multidose topical eye drops on multiple patients. The position statement, developed by the ASCRS Cataract Clinical Com- mittee, comes in the wake of some surgery centers being compelled to cease certain long-accepted topical treatments for preoperative patients. "Some members reported that surveyors have arbitrarily proscribed these well-established and common practices, without any evidence that they pose greater risk," said David F. Chang, MD, ASCRS past president and Cataract Clinical Committee member. ASCRS position statement Current literature strongly supports the use of preoperative povidone-io- dine solution for cataract (ophthal- mic) surgery antisepsis and endoph- thalmitis prevention. Specifically, instillation of 5% povidone-iodine solution in the conjunctival sac has been shown to be effective for endophthalmitis prophylaxis. This practice has been used almost uni- versally in ophthalmic surgery for decades. One common method of preparing the 5% solution is by diluting commercially available 10% povidone-iodine (Betadine) with a saline solution. A recent ASCRS survey revealed that 1 in 3 ASCs (ambulatory surgery centers) prepare their surgical prep in this way. This practice has been shown to be safe and effective despite the labeling "Do not use in the eye," present on the 10% Betadine solution. More recently, individually packaged 5% povidone-iodine preps have become commercially available, but at a significant cost premium. Another well-established practice is the use of multidose eye drops on multiple patients as part of the preoperative surgical protocol (i.e., dilating drops, NSAIDs, etc.). The safety and cost effectiveness of multidose bottles are well recog- nized in the clinic and in the surgery setting. Safety guidelines have been established for the safe use of these products including: expiration 28 days after initial use, proper dispens- ing technique, and discarding of any bottle with suspected tip contami- nation. BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE Ocular Surgery DUREZOL ® a topical corticosteroid, is indicated for the treatment surgery. Endogenous Anterior Uveitis DUREZOL ® Emulsion is also indicated for the treatment of endogenous anterior uveitis. DOSAGE AND ADMINISTRATION Ocular Surgery eye 4 times daily beginning 24 hours after surgery postoperative period, followed by 2 times daily for a week and then a taper based on the response. Endogenous Anterior Uveitis eye 4 times daily for 14 days followed by tapering as clinically indicated. DOSAGE FORMS AND STRENGTHS DUREZOL ® a sterile preserved emulsion for topical ophthalmic administration. CONTRAINDICATIONS The use of 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 disease of ocular structures. WARNINGS AND PRECAUTIONS IOP Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure 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 slit lamp biomicroscopy and, where appropriate, 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. Fungal culture should be taken when appropriate. Topical Ophthalmic Use Only DUREZOL ® Emulsion is not indicated for intraocular administration. 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. ADVERSE REACTIONS Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Ocular Surgery Ocular adverse reactions occurring in 5-15% of subjects in clinical studies with DUREZOL ® Emulsion included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule ocular adverse reactions occurring in 1-5% of subjects included reduced visual acuity, punctate keratitis, occurring in < 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritus, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, sclera hyperemia, and uveitis. Most of these reactions may have been the consequence of the surgical procedure. Endogenous Anterior Uveitis A total of 200 subjects participated in the clinical trials for endogenous anterior uveitis, of which 106 were exposed to DUREZOL ® Emulsion. The most common adverse reactions of those exposed to DUREZOL ® Emulsion 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. Adverse reactions occurring in 2-5% of subjects included anterior photophobia, and reduced visual acuity. USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic E shown to be embryotoxic (decrease in embryonic and teratogenic (cleft palate and skeletal) anomalies when administered subcutaneously to rabbits during organogenesis at a dose of 1–10 mcg/kg/day. The to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females. Treatment of rats with 10 mcg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic. At 100 mcg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and human doses of DUREZOL ® Emulsion, since DUREZOL ® Emulsion is administered topically with minimal were not measured in the reproductive animal studies. pregnancy has not been evaluated and cannot rule out the possibility of harm, DUREZOL ® Emulsion should Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward ® Emulsion is administered to a nursing woman. Pediatric Use Geriatric Use been observed between elderly and younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, and Impairment of Fertility in vitro in the Ames test, and in cultured mammalian cells CHL/IU (a female Chinese hamsters). An in vivo micronucleus Treatment of male and female rats with subcutaneous mating did not impair fertility in either gender. Long term studies have not been conducted to evaluate the Animal Toxicology and/or Pharmacology In multiple studies performed in rodents and non-rodents, subchronic and chronic toxicity tests as suppression of body weight gain; a decrease in lymphocyte count; atrophy of the lymphatic thinning of the skin; all of which were due to the pharmacologic action of the molecule and are well The NOEL for the subchronic and chronic toxicity tests were consistent between species and ranged from 1–1.25 mcg/kg/day. PATIENT COUNSELING INFORMATION Risk of Contamination This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the emulsion. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery. Risk of Secondary Infection becomes aggravated, the patient should be advised to consult a physician. Contact Lens Wear DUREZOL ® Emulsion should not be instilled while wearing contact lenses. Patients should be advised to 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. Revised: May 2013 U.S. Patent 6,114,319 DUREZOL ® Emulsion was evaluated in a 3-month, multicenter, double-masked, trial in 79 pediatric patients (39 DUREZOL ® Emulsion; 40 prednisolone acetate) 0 to 3 years of age for the treatment of inammation following cataract surgery. A similar safety prole was observed in pediatric patients comparing DUREZOL ® Emulsion to prednisolone acetate ophthalmic suspension, 1%. © 2014 Novartis 3/14 DUR14031JAD Manufactured For: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 USA 1-800-7579195 Manufactured By: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 USA or Catalent Pharma Solutions Woodstock, IL 60098 11.375" Bleed 10.875" Trim 9.875" Live ©2014 Novartis 1/15 DUR14090JAD continued on page 8

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