MAR 2014

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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Two studies approach the treatment of myopia in children in one Asian country T h e Atropine in the Treat- ment of Myopia (ATOM) study found that atropine eye drops reduced myopia progression and axial elon- gation in children in a dose-related by Erin L. Boyle EyeWorld Senior Staff Writer ATOM trials find atropine eye drops reduce myopia progression E W NEWS & OPINION 38 March 2014 BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE O cular Surgery DUREZOL ® a topical corticosteroid, is indicated for the treatment surgery. Endogenous Anterior Uveitis D UREZOL ® E mulsion 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 c linically indicated. D OSAGE FORMS AND STRENGTHS D UREZOL ® a sterile preserved emulsion for topical ophthalmic administration. CONTRAINDICATIONS The use of DUREZOL ® E mulsion, as with other o phthalmic 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 m ycobacterial infection of the eye and fungal disease o f 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 a ny persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken w hen appropriate. Topical Ophthalmic Use Only D UREZOL ® Emulsion is not indicated for intraocular administration. Contact Lens Wear D UREZOL ® E mulsion should not be instilled while wearing contact lenses. Remove contact lenses prior to i nstillation of DUREZOL ® E mulsion. The preservative in DUREZOL ® Emulsion may be absorbed by soft contact l enses. Lenses may be reinserted after 10 minutes following administration of DUREZOL ® Emulsion. A DVERSE 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 h erpes 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 s ubjects in clinical studies with DUREZOL ® E mulsion included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule o cular 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 pruritis, 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 ® E mulsion is administered to a nursing woman. Pediatric Use Geriatric Use b een 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 f emale Chinese hamsters). An in vivo micronucleus T reatment 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 infammation following cataract surgery. A similar safety profle was observed in p ediatric patients comparing DUREZOL ® Emulsion to prednisolone acetate ophthalmic suspension, 1%. © 2013 Novartis 8/13 DUR13148JAD Manufactured For: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 USA 1-800-757‐9195 Manufactured By: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 USA or Catalent Pharma Solutions Woodstock, IL 60098 w ay. The study also found a rebound phenomenon with higher doses of the eye drop, said Donald T.H. Tan, FRCOphth, head and senior consultant, Singapore National Eye Centre. " We think that atropine eye drops are safe with no serious ad- verse or systemic effects, but in the higher doses, the side effects of pupil dilation, loss of accommodation, and near vision limit practical use," he said. In his talk "New strategies for the prevention of myopia," pre- s ented at the 2013 European Society of Cataract & Refractive Surgeons (ESCRS) Congress, he outlined tradi- tional methods for reducing myopia progression, including spectacle undercorrection or overcorrection; contact lens use, including soft, rigid, dual focus, and peripheral defocus lenses; and pharmacological m ethods, including muscarinic an- tagonists. Dr. Tan said there are more than 180 interventional studies in the lit- erature on the topic, one that is of vital importance around the world, especially in Eastern Asia. The trials were conducted at the Singapore Eye Research Institute. Singapore is the "myopia capital of the world," Dr. Tan said, with approximately 80% of teenagers myopic by 18 years of age and 13% with high myopia. "This is really very high," he said. "The myopia rates in East Asia are the highest in the world, but this is a global phenomenon that started in the '70s." In the last 14 years of clinical trials, the two ATOM studies have shown that atropine eye drops can reduce myopia progression in a dose-related manner. However, a rebound affect can happen with higher doses. The lower dose of 0.01% atropine "appears to have the best therapeutic index with clini- cally few, relatively insignificant amounts of pupil dilatation, near vi- sion, and accommodation loss, and yet appears to be fairly similar in ef- ficacy to higher doses," Dr. Tan said. "That means, overall, 0.01% [atropine eye drops] seem to slow myopic progression by 60% in our Asian population, and without any of the side-effects associated with higher doses," he said. ATOM1 The ATOM1 was a randomized, double-masked, placebo-controlled clinical trial. It was designed to determine the safety and efficacy of atropine eye drops on myopia progression in children. 18-47 News_EW March 2014-DL2 copy_Layout 1 3/6/14 2:47 PM Page 38

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