Eyeworld

EW NEWS & OPINION 22 fillers are reliable, natural looking, safe, and predictable when injected properly." Effects of these are re- versible with use of hyaluronidase in the case of a complication, she pointed out. Hyaluronic acid fillers such as Restylane (Valeant Pharma- ceuticals, Madison, N.J.), Perlane (Valeant Pharmaceuticals), Juvederm Ultra (Allergan), Juvederm Voluma (Allergan), and Belotero (Merz Aesthetics) can all be used for different purposes and in different areas, allowing for full facial rejuvenation, Dr. Kaufman said. Dr. Yoelin agreed that reversibil- ity is a big advantage of the hyaluronic acid fillers, adding, "Not that you do it often, but it's nice to have the ability to remove or erase the effects of a filler." Another type of filler that is available in the U.S. is calcium hydroxylapatite or Radiesse (Merz Aesthetics). "It's versatile but not as versatile as a hyaluronic acid filler," he said. "Many practitioners use this product to augment bony structures such as cheekbones and chins, but you can use it in other places as well." For example, some practition- ers place it on the top of patients' hands. Another product, poly-L-lactic acid (Sculptra, Valeant Pharmaceuti- cals), serves as a collagen stimulator. "Several weeks after Sculptra is in- jected, a collagen response occurs in the area of the face where the prod- uct was placed, and this collagen response will continue to occur for many months," Dr. Yoelin said. "Typically patients are injected every six weeks or so for a total of three treatment cycles." Small micros- pheres of particles of poly-L-lactic acid stimulate the body's own fibroblasts to create a collagen re- sponse. This collagen response lasts for about 25 months, Dr. Yoelin said. "Sculptra injectors often treat a vari- ety of facial compartments or areas during each treatment session." Regardless of the product or products that a practitioner selects to use, Dr. Yoelin urges practitioners to make a commitment to learning as much as possible about these products. He suggested getting other key staff members on board so that these individuals can help educate patients regarding the attributes of the various products and procedures that are available. Additionally, the office should look appealing, he stressed. "If a physician would like to begin treat- ing patients who wish to undergo these procedures, it will be advanta- geous for the physician to begin with the office waiting area and treatment area to accommodate injectables patients. The office and treatment room should create a relaxing and calm environment." "It is not necessary to have an enormous aesthetic client base to be successful," Dr. Yoelin said. Each year, he sees about 1,500 aesthetics patients who come in regularly. "Each patient returns two or three times a year—which totals 3,000 to 4,000 annual visits, which is about the maximum number of treatment sessions that I choose to perform on an annual basis," he said. "As a re- sult, you don't need an enormous number of patients to have a busy injectables practice." EW Reference 1. 14.6 Million Cosmetic Plastic Surgery Procedures Performed in 2012. American Society of Plastic Surgeons, 2013. Available at: www.plasticsurgery.org/news/press- release-archives/2013/14-million-cosmetic- plastic-surgery-procedures-performed- in-2012.html. Editors' note: Dr. Kaufman has finan- cial interests with Allergan and Merz. Dr. Yoelin has financial interests with Allergan and Valeant Pharmaceuticals. Contact information Kaufman: drjkaufman@gmail.com Yoelin: syoelinmd@gmail.com May 2014 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 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 ® 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%. © 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 Aesthetic continued from page 21

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