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The Lowdown on High-Tech Iols

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The Lowdown on High-Tech Iols ® EyeNetOCTOBER 2017 International Report The Lowdown on High-Tech IOLs Unintended Consequences New Cancer Drugs, New Ocular Side Effects Bioptic Lenses for Driving? Counseling Low Vision Patients OPINION The Enduring Appeal of Solo Practice OHH, IINTERESTING The fi rst prescription eye drop FDA-approved to treat both the signs and symptoms of Dry Eye Disease Indication Xiidra® (lifi tegrast ophthalmic solution) 5% is indicated for the treatment of signs and symptoms of dry eye disease (DED). Xiidra is a lymphocyte function-associated antigen-1 Important Safety Information In clinical trials, the most common adverse reactions reported in 5-25% (LFA-1) antagonist, the fi rst of patients were instillation site irritation, dysgeusia and reduced visual medication in a new class acuity. Other adverse reactions reported in 1% to 5% of the patients 1 of drugs. were blurred vision, conjunctival hyperemia, eye irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus Check it out at Xiidra-ECP.com and sinusitis. Reference: 1. FDA approves new medication for To avoid the potential for eye injury or contamination of the solution, dry eye disease. FDA News Release. July 2016. patients should not touch the tip of the single-use container to their http://www.fda.gov/newsevents/newsroom/ eye or to any surface. pressannouncements/ucm510720.htm. Accessed July 12, 2016. Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration. Safety and effi cacy in pediatric patients below the age of 17 years have not been established. For additional safety information, see accompanying Brief Summary of Safety Information on the adjacent page and Full Prescribing Information on Xiidra-ECP.com. Marks designated ® and ™ are owned by Shire or an affi liated company. ©2016 Shire US Inc. Lexington, MA 02421 S24432 11/16 Animal Data Lifitegrast administered daily by intravenous (IV) injection to rats, from pre-mating through gestation day 17, caused an increase in mean preimplantation loss and an increased incidence of several minor skeletal anomalies at 30 mg /kg /day, representing 5,400-fold Rx Only the human plasma exposure at the RHOD of Xiidra, based on AUC. No teratogenicity was observed in the rat at BRIEF SUMMARY: Consult the Full Prescribing Information for complete 10 mg /kg /day (460-fold the human plasma exposure at product information. the RHOD, based on AUC ). In the rabbit, an increased incidence of omphalocele was observed at the lowest dose tested, 3 mg /kg /day (400-fold the human INDICATIONS AND USAGE plasma exposure at the RHOD, based on AUC), when ® Xiidra (lifitegrast ophthalmic solution) 5% is indicated administered by IV injection daily from gestation days 7 for the treatment of the signs and symptoms of dry eye through 19. A fetal No Observed Adverse Effect Level disease (DED). (NOAEL) was not identified in the rabbit. DOSAGE AND ADMINISTRATION Lactation Instill one drop of Xiidra twice daily (approximately 12 There are no data on the presence of lifitegrast in human hours apart) into each eye using a single use container. milk, the effects on the breastfed infant, or the effects on Discard the single use container immediately after using milk production. However, systemic exposure to lifitegrast in each eye. Contact lenses should be removed prior to from ocular administration is low. The developmental and the administration of Xiidra and may be reinserted 15 health benefits of breastfeeding should be considered, minutes following administration. along with the mother’s clinical need for Xiidra and any potential adverse effects on the breastfed child from Xiidra. ADVERSE REACTIONS Clinical Trials Experience Because clinical studies are conducted under widely Pediatric Use Safety and efficacy in pediatric patients below the age of varying conditions, adverse reaction rates observed in 17 years have not been established. clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may Geriatric Use not reflect the rates observed in practice. In five clinical No overall differences in safety or effectiveness have been studies of dry eye disease conducted with lifitegrast observed between elderly and younger adult patients. ophthalmic solution, 1401 patients received at least 1 dose of lifitegrast (1287 of which received lifitegrast 5%). The majority of patients (84%) had ≤3 months of NONCLINICAL TOXICOLOGY treatment exposure. 170 patients were exposed to Carcinogenesis, Mutagenesis, Impairment of Fertility lifitegrast for approximately 12 months. The majority Carcinogenesis: Animal studies have not been conducted of the treated patients were female (77%). The most to determine the carcinogenic potential of lifitegrast. common adverse reactions reported in 5-25 % of patients Mutagenesis: Lifitegrast was not mutagenic in the in vitro were instillation site irritation, dysgeusia and reduced Ames assay. Lifitegrast was not clastogenic in the in vivo visual acuity. Other adverse reactions reported in 1% mouse micronucleus assay. In an in vitro chromosomal to 5% of the patients were blurred vision, conjunctival aberration assay using mammalian cells (Chinese hyperemia, eye irritation, headache, increased hamster ovary cells), lifitegrast was positive at the highest lacrimation, eye discharge, eye discomfort, eye pruritus concentration tested, without metabolic activation. and sinusitis. Impairment of fertility: Lifitegrast administered at intravenous (IV) doses of up to 30 mg/kg/day (5400-fold the human plasma exposure at the USE IN SPECIFIC POPULATIONS recommended human ophthalmic dose (RHOD) of Pregnancy lifitegrast ophthalmic solution, 5%) had no effect on There are no available data on Xiidra use in pregnant fertility and reproductive performance in male and women to inform any drug associated risks. Intravenous female treated rats. (IV) administration of lifitegrast to pregnant rats, from pre-mating through gestation day 17, did not produce teratogenicity at clinically relevant systemic exposures. Intravenous administration of lifitegrast to pregnant Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421. rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, For more information, go to www.Xiidra.com or call 1-800-828-2088. 3 mg/kg/day (400-fold the human plasma exposure at Marks designated ® and ™ are owned by Shire the recommended human ophthalmic dose [RHOD], or an affiliated company. based on the area under the curve [AUC] level). Since ©2016 Shire US Inc. human systemic exposure to lifitegrast following US Patents: 8367701; 9353088; 7314938; 7745460; 7790743; ocular administration of Xiidra at the RHOD is low, the 7928122; 9216174; 8168655; 8084047; 8592450; 9085553; 8927574; applicability of animal findings to the risk of Xiidra use in 9447077; 9353088 and pending patent applications. humans during pregnancy is unclear. Last Modified: 12/2016 S26218 Celebrating 1 Years1 of the Malyugin Ring® Years of the Malyugin Ring® 2007 2014 2014 2016 2017 Introduction2007 of Implementation2014 1,000,000th2014 Introduction2016 of Ophthalmology2017 Introductionthe Malyugin of Implementationof the Osher Malyugin1,000,000th Ring Introductionthe Malyugin of OphthalmologyCelebrates 10 the MalyuginRing Modificationof the Osher MalyuginShipped Ring theRing Malyugin 2.0 CelebratesYears of the 10 Ring Modification Shipped Ring 2.0 MalyuginYears of Ringthe Malyugin Ring Try the Malyugin Ring 2.0 Today! 1-888-279-3323Try the Malyugin | [email protected] Ring 2.0 Today! 1-888-279-3323 | [email protected] bit.ly/MSTfacebook @MST_eye www.microsurgical.combit.ly/MSTfacebook @MST_eye www.microsurgical.com Every Clinical Trial is Unique . and accuracy and efficiency is critical. The M&S Technologies Clinical Trial Suite (CTS) delivers on these needs from site to site and patient to patient. • EVA (electronic visual acuity) • Contrast Threshold Testing • Automated ETDRS at distance, intermediate* and near* • Glare Testing under photopic / mesopic luminance levels • Defocus Curve (configurable from +2 to –5 Diopters) • Automated Contrast Sensitivity Function System (ACSFS) utilizing sinusoidal bullseye targets • Contrast Acuity Testing at 1.25%, 2.5%, 5%, 10% or 25% * High-resolution laptop required • Linear Sine Grating Contrast Testing with multiple orientations Plus, call to learn more about the NEW Smart System® 2 or demo it the at AAO-MD show in New Orleans, Nov. 11-14 Call today! 1-847-763-0500 The First Choice in Vision Testing Systems mstech-eyes.com @2017 M&S Technologies , Inc. Smart System and M&S are registered trademarks of M&S Technologies. All rights reserved. M&S holds US Patents 7,354,155; 7,926,948; 8,425,040; 8,167,429; 8,419,184 & 8,550,631. Other Patents Pending. Software development in the USA ACCESS PROGRAM EXCLUSIVELYOFFER AT AVAILABLE WALGREENS AT OVER AND OTHER PARTICIPATING30,000 PHARMACIES INDEPENDENT NATIONWIDE PHARMACIES PRESCRIBE WITH CONFIDENCE AFFORDABLE ACCESS FOR YOUR ELIGIBLE PATIENTS MOST ELIGIBLE COMMERCIALLY INSURED PATIENTS PAY NO MORE THAN*: CO-PAY $ 1st and Refi lls Discounted pricing available 35 for eligible uninsured patients* *Terms and conditions apply. Please see www.bauschaccessprogram.com for eligibility criteria and terms and conditions. LOTEMAX® GEL SPECIAL OFFER $ MOST ELIGIBLE COMMERCIALLY INSURED PATIENTS PAY NO MORE THAN* 25 CO-PAY AVAILABLE FOR ZIRGAN®: A SAVINGS UP TO $35 OFF FOR ELIGIBLE COMMERCIALLY
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