EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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30 EW NEWS & OPINION October 2013 Update continued from page 29 but you put the ointment on the lid margin and it stays for longer." Unchecked blepharitis can damage the meibomian glands, which are just millimeters away from the lashes, Dr. Maskin said. This, he finds, can cause meibomian gland inflammation and periglandular fibrosis, which can lead to ductal obstruction to meibum flow with elevated intraductal pressure and subsequent loss of glandular tissue. Dr. Maskin said that he recently pioneered a technique making it possible to get inside the gland, ensuring that it is open. "The ability to physically get inside of a gland and remove the obstruction is a game changer and has produced dramatic and immediate results in my patients," he said. Along with this new technique has come the idea of being able to deliver therapies inside the gland. any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate. 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 reevaluated. 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 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 "Not only do we have probes that open up the gland, we have tubes that I insert inside the gland," Dr. Maskin said. He has already injected different types of steroids here in more advanced cases. A wax ester compound called jojoba, which together with lidocaine forms the basis of the anesthetic used for probing the gland, plays a key role here and can be ordered from Leiter's Pharmacy. 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 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 pediatric patients comparing DUREZOL® Emulsion to prednisolone acetate ophthalmic suspension, 1%. secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Geriatric Use 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 NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, and Impairment of Fertility in vitro in the Ames test, and in cultured mammalian cells CHL/IU (a been observed between elderly and younger patients. female Chinese hamsters). An in vivo micronucleus ocular adverse reactions occurring in 1-5% of subjects included reduced visual acuity, punctate keratitis, Treatment of male and female rats with subcutaneous 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. mating did not impair fertility in either gender. Long term studies have not been conducted to evaluate the 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 as suppression of body weight gain; a decrease in lymphocyte count; atrophy of the lymphatic photophobia, and reduced visual acuity. USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic E shown to be embryotoxic (decrease in embryonic Animal Toxicology and/or Pharmacology In multiple studies performed in rodents and non-rodents, subchronic and chronic toxicity tests 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. and teratogenic (cleft palate and skeletal) anomalies when administered subcutaneously to rabbits during organogenesis at a dose of 1–10 mcg/kg/day. The Risk of Secondary Infection 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 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. human doses of DUREZOL® Emulsion, since DUREZOL® Emulsion is administered topically with minimal becomes aggravated, the patient should be advised to consult a physician. Revised: May 2013 U.S. Patent 6,114,319 were not measured in the reproductive animal studies. 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 pregnancy has not been evaluated and cannot rule out the possibility of harm, DUREZOL® Emulsion should © 2013 Novartis 8/13 DUR13148JAD "The main secretion of the meibomian gland are wax esters," Dr. Maskin said. "The jojoba seems to escort the anesthetic into the tarsal plate in the gland, allowing for welltolerated probing." The probing technique involves beginning with a very stiff 1-mm probe, getting into the gland, and breaking through fibrotic tissue to establish and confirm a patent outflow duct, Dr. Maskin explained. If this does not stretch far enough to reach deeper obstructions, a longer probe can then be used. Overall, Dr. Maskin views this as an exciting era for treating lid margin disease. "I've been practicing for almost 25 years, and this is the most exciting time to be treating lid margin disease, meibomian gland disease, and dry eye," he said. "Why? Because we can now for the first time treat meibomian gland disease with an approach that enables us to get inside of the gland and release occult resistance to meibum flow throughout the entire ductal system, to open it up, and restore gland functionality." Dr. Tseng is extremely gratified that blepharitis in particular is now gaining its share of attention. "I think it's a good thing for the research community and pharmaceutical community together to focus and take an active interest in this because it is an important, common, and annoying eye condition afflicting a large population," he said. However, he cautioned that more research is needed into what he sees as a multifactorial issue. "On the one hand mites are parasitic and then on the other there may be some bacteria," he said. "I think effective treatment should be merged, and we believe that we made the first step toward that goal." EW Editors' note: Dr. Maskin has a patent on the use of jojoba to treat meibomian gland disease and pending patents on the intraductal meibomian gland apparatus and methods, as well as a license agreement with Rhein Medical (St. Petersburg, Fla.). Dr. Tseng has financial interests with Bio-Tissue. Contact information Maskin: 813-875-0000, drmaskin@tampabay.rr.com Tseng: 305-274-1299, stseng@ocularsurface.com