Eyeworld

EW NEWS & OPINION 22 September 2015 Nancy H. Coles, MD Associate attending, Manhattan Eye, Ear & Throat Hospital, North Shore LIJ Attending surgeon, New York Eye & Ear Infirmary of Mt. Sinai I find astigmatism and its correc- tion to be one of the most difficult concepts to explain to my patients. After I have discussed the need for cataract surgery with patients and obtained informed consent, I review which implant is best suited to their eye. I explain that once I remove the tarnished natural lens of the eye, I replace it with an intraocular lens implant. There are many variations of lens implants and selecting the optimum lens depends both upon the patient's needs and the eye's measurements. I explain that in addition to being farsighted (hy- peropic) or nearsighted (myopic), which refers to the length, an eye can have astigmatism. This refers to the shape of the eye we are born with, the way some people are short or tall. I use my hands to demon- strate the difference between an eye without astigmatism that is shaped like a baseball where the radius of curvature is the same no matter how you slice it and an eye with astig- matism that is shaped more like a football where there is a long and a short radius of curvature. As a result, the light rays focus in 2 different places in the retina, resulting in blurred vision. If the patient has 1 D or less of astigmatism, I discuss using the femtosecond laser to make corneal relaxing incisions to correct the astigmatism and at the same time customizing the laser to their partic- ular cataract allowing for a gentler procedure. If we decide against using the femto laser, I offer a penetrat- ing relaxing incision and make my surgical incision on axis with the patient's astigmatism. In the event that they have more than 1 D of astigmatism, I offer my patients a toric implant. This customized implant corrects the radius of curvature is different one way vs. 90 degrees the other way. We explain that if the cornea is football-shaped it has 2 points of focus that will need to be corrected by glasses. Then we say that if they have significant corneal astigmatism, we can select an intraocular lens that has a subtle shape cast into its surface that will cancel out their Communicating continued from page 20 RESTASIS ® (Cyclosporine Ophthalmic Emulsion) 0.05% BRIEF SUMMARY—PLEASE SEE THE RESTASIS ® PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION. INDICATION AND USAGE RESTASIS ® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular infl ammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-infl ammatory drugs or using punctal plugs. CONTRAINDICATIONS RESTASIS ® is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. WARNINGS AND PRECAUTIONS Potential for Eye Injury and Contamination To avoid the potential for eye injury and contamination, be careful not to touch the vial tip to your eye or other surfaces. Use with Contact Lenses RESTASIS ® should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS ® ophthalmic emulsion. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not refl ect the rates observed in practice. In clinical trials, the most common adverse reaction following the use of RESTASIS ® was ocular burning (17%). Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring). Post-marketing Experience The following adverse reactions have been identifi ed during post approval use of RESTASIS ® . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superfi cial injury of the eye (from the vial tip touching the eye during administration). USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy Category C Adverse effects were seen in reproduction studies in rats and rabbits only at dose levels toxic to dams. At toxic doses (rats at 30 mg/kg/day and rabbits at 100 mg/kg/day), cyclosporine oral solution, USP, was embryo- and fetotoxic as indicated by increased pre- and postnatal mortality and reduced fetal weight together with related skeletal retardations. These doses are 5,000 and 32,000 times greater (normalized to body surface area), respectively, than the daily human dose of one drop (approximately 28 mcL) of 0.05% RESTASIS ® twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal toxicity was observed in rats or rabbits receiving cyclosporine at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively, during organogenesis. These doses in rats and rabbits are approximately 3,000 and 10,000 times greater (normalized to body surface area), respectively, than the daily human dose. Offspring of rats receiving a 45 mg/kg/day oral dose of cyclosporine from Day 15 of pregnancy until Day 21 postpartum, a maternally toxic level, exhibited an increase in postnatal mortality; this dose is 7,000 times greater than the daily human topical dose (0.001 mg/kg/day) normalized to body surface area assuming that the entire dose is absorbed. No adverse events were observed at oral doses up to 15 mg/kg/day (2,000 times greater than the daily human dose). There are no adequate and well-controlled studies of RESTASIS ® in pregnant women. RESTASIS ® should be administered to a pregnant woman only if clearly needed. Nursing Mothers Cyclosporine is known to be excreted in human milk following systemic administration, but excretion in human milk after topical treatment has not been investigated. Although blood concentrations are undetectable after topical administration of RESTASIS ® ophthalmic emulsion, caution should be exercised when RESTASIS ® is administered to a nursing woman. Pediatric Use The safety and effi cacy of RESTASIS ® ophthalmic emulsion have not been established in pediatric patients below the age of 16. Geriatric Use No overall difference in safety or effectiveness has been observed between elderly and younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Systemic carcinogenicity studies were carried out in male and female mice and rats. In the 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically signifi cant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males signifi cantly exceeded the control value. In the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas signifi cantly exceeded the control rate in the low-dose level. The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice and rats are approximately 80 times greater (normalized to body surface area) than the daily human dose of one drop (approximately 28 mcL) of 0.05% RESTASIS ® twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. Mutagenesis: Cyclosporine has not been found to be mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA- repair test in sperm from treated mice. A study analyzing sister chromatid exchange (SCE) induction by cyclosporine using human lymphocytes in vitro gave indication of a positive effect (i.e., induction of SCE). Impairment of Fertility: No impairment in fertility was demonstrated in studies in male and female rats receiving oral doses of cyclosporine up to 15 mg/kg/day (approximately 2,000 times the human daily dose of 0.001 mg/kg/day normalized to body surface area) for 9 weeks (male) and 2 weeks (female) prior to mating. PATIENT COUNSELING INFORMATION Handling the Container Advise patients to not allow the tip of the vial to touch the eye or any surface, as this may contaminate the emulsion. To avoid the potential for injury to the eye, advise patients to not touch the vial tip to their eye. Use with Contact Lenses RESTASIS ® should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. Advise patients that if contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS ® ophthalmic emulsion. Administration Advise patients that the emulsion from one individual single-use vial is to be used immediately after opening for administration to one or both eyes, and the remaining contents should be discarded immediately after administration. Rx Only Based on package insert 71876US18 © 2014 Allergan, Inc. Irvine, CA 92612, U.S.A. ® marks owned by Allergan, Inc. APC21XT14 Patented. See www.allergan.com/products/patent_notices Made in the U.S.A. Live: w 4.36" x h 9.25" NOTES: File is sized to Live Area. Bleed: corneal astigmatism so that they have less need for glasses when they are done. I usually hold my hands up as I'm explaining this and hold my left hand up like a vertical karate chop, then I put my right hand in front of that like a horizontal karate chop and say that it's like having 2 footballs that compensate for each other, creating the desired 1-focus basketball shape (Figure 2). I say it takes the astigmatism correction that would be in your glasses (I point to my glasses) and puts it into your eye (I point to my eye) so that you won't need the glasses to see clearly. We discuss that the degree of perfection of this correction depends on measurements and calculations, which even though they are good, they are not perfect. We tell them that even with the modern measure- ments and calculations, astigmatism correction is still like throwing darts at a dart board (I use my hands in a throwing motion). We can get pretty close, but we hardly ever get per- fect, so we shouldn't expect perfect. We tell them it is pretty likely that if they have this technology, they would be able to pass a driver's test without glasses. In significant myopes, we do discuss the fact that their eyes are large and that sometimes toric lenses can rotate in large eyes after surgery. If that were to happen, we might have to reorient them with another surgery 2–3 weeks after the initial surgery, but we explain that this is a rare and insurance-covered event. If patients have corneal anterior basement membrane dystrophy and significant astigmatism, we can still talk to them about toric IOLs. But if they have modest astigmatism and substantial dystrophy we usually just tell them that they probably won't have a day-to-day consistent result and they would be less likely to be happy, so they shouldn't bother spending the extra money. If need- ed, we show them their Pentacam image vs. a normal bow tie image. One of the most detailed expla- nations is that of minimal preoper- ative refractive cylinder but signif- icant corneal astigmatism that has been compensated for by lenticular astigmatism. We have to get out the eye model and point to the cornea and lens and explain that their eye has always corrected the corneal astigmatism with its lenticular astig- matism. I show them my 2 hands together in the karate chop, then take away the one that represents the lenticular astigmatism, which leaves the other alone representing the keratometric astigmatism that will no longer be compensated for. We explain that their glasses correction will likely be worse than they've experienced. Finally, it is important to remember that some nearsighted patients want to stay nearsighted after surgery. We need to explain to them the value toric technology would have in helping achieve good uncorrected near vision.

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