Eyeworld

EW IN OTHER NEWS 82 May 2018 seven. …You've got to be willing to put up with quite a bit of rejection," he said. Dr. Haight said he sees cross- word puzzle construction as a chal- lenge, which is why he keeps it up despite the rejection rate. He went from making three to four puzzles a week while he was overcoming the crossword-constructing learning curve to only doing about one to one and a half now. Making a crossword puzzle starts with a theme. Dr. Haight said he will sometimes get inspiration for themes from things he sees in ev- eryday life, and other times it comes from browsing through old puzzles. "They want an interesting theme that hasn't been done before or maybe you have a new twist on it," Dr. Haight said. After fitting his theme words into a 15x15 grid for a weekday puzzle—21x21 if it's for a Sunday— and adding black squares, Dr. Haight uses a program to populate fill words into the empty boxes. It takes some time to find fill words that you want to keep in the puzzle. "The second best thing that [editors] are interested in is the fill; they want interesting fill words," Dr. Haight said. Once the fill words are popu- lated, he creates clues. Clues for a Monday crossword will be easier, getting tougher as the week pro- gresses. Saturday is the toughest day of the week. A good portion of these clues will likely be changed by the crossword's editor, but Dr. Haight said it's mostly the theme and fill words that influence selection of a puzzle. After completing a puzzle—a weekday puzzle takes 4–5 hours— Dr. Haight submits it. While the Los Angeles Times accepts electronic submissions, Dr. Haight said Mr. Shortz with The New York Times is old fashioned and only takes print submissions through the mail. Dr. Haight has created a cou- ple of puzzles with ophthalmology themes. Two have featured the giant E on the Snellen eye chart. One of those did not have any words featur- ing the letter "e." "It was pretty hard to come up with a puzzle with no Es," he said. Another was based off of the words, "I SEE." While "I SEE" was one of the fill words that provided a clue to the theme, the actual theme was words starting with "I" and "C," such as "Internet café." A Valentine's Day puzzle where the theme was "BOXED ROSES" included "BOXED" and "ROSES" in the center and at four points in the puzzle where the letters "r," "o," "s," and "e," formed the shape of a 2x2 box. Dr. Haight also makes crossword puzzles with images, called grid art. His creations have featured a Scottish terrier, fish, birds, and bats. Constructing these "visual puzzles" is something Dr. Haight said he enjoys. As for goals for this hobby, Dr. Haight said he has never gotten a Saturday slot in The New York Times before. While it's "kind of" a goal of his, he said he won't be surprised if he doesn't get it. The Saturday Times crossword is notoriously difficult to solve, and he doesn't try his hand at this level too often, only 2–3 times per year. Another goal is to make it to 100 puzzles accepted by The New York Times. If he sticks with it for another 10 years, Dr. Haight said he thinks he'll make it. EW Contact information Haight: bhaight2020@yahoo.com BRIEF SUMMARY: Consult the Full Prescribing Information for complete product information. INDICATIONS AND USAGE Xiidra ® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). DOSAGE AND ADMINISTRATION Instill one drop of Xiidra twice daily (approximately 12 hours apart) into each eye using a single-use container. Discard the single-use container immediately after using in each eye. Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration. CONTRAINDICATIONS Xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation. ADVERSE REACTIONS Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In five clinical studies of dry eye disease conducted with lifitegrast 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 treatment exposure. 170 patients were exposed to lifitegrast for approximately 12 months. The majority of the treated patients were female (77%). The most common adverse reactions reported in 5-25 % of patients were instillation site irritation, dysgeusia and reduced visual acuity. Other adverse reactions reported in 1% to 5% of the patients were blurred vision, conjunctival hyperemia, eye irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus and sinusitis. Postmarketing Experience The following adverse reactions have been identified during postapproval use of Xiidra. 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. Rare cases of hypersensitivity, including anaphylactic reaction, bronchospasm, respiratory distress, pharyngeal edema, swollen tongue, and urticaria have been reported. Eye swelling and rash have been reported. USE IN SPECIFIC POPULATIONS Pregnancy There are no available data on Xiidra use in pregnant women to inform any drug associated risks. Intravenous (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 rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the recommended human ophthalmic dose [RHOD], based on the area under the curve [AUC] level). Since human systemic exposure to lifitegrast following ocular administration of Xiidra at the RHOD is low, the applicability of animal findings to the risk of Xiidra use in humans during pregnancy is unclear. 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 the human plasma exposure at the RHOD of Xiidra, based on AUC. No teratogenicity was observed in the rat at 10 mg /kg /day (460-fold the human plasma exposure at 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 plasma exposure at the RHOD, based on AUC), when administered by IV injection daily from gestation days 7 through 19. A fetal No Observed Adverse Effect Level (NOAEL) was not identified in the rabbit. Lactation There are no data on the presence of lifitegrast in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to lifitegrast from ocular administration is low. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for Xiidra and any potential adverse effects on the breastfed child from Xiidra. Pediatric Use Safety and efficacy in pediatric patients below the age of 17 years have not been established. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Animal studies have not been conducted to determine the carcinogenic potential of lifitegrast. Mutagenesis: Lifitegrast was not mutagenic in the in vitro Ames assay. Lifitegrast was not clastogenic in the in vivo mouse micronucleus assay. In an in vitro chromosomal aberration assay using mammalian cells (Chinese hamster ovary cells), lifitegrast was positive at the highest concentration tested, without metabolic activation. Impairment of fertility: Lifitegrast administered at intravenous (IV) doses of up to 30 mg/kg/day (5400-fold the human plasma exposure at the recommended human ophthalmic dose (RHOD) of lifitegrast ophthalmic solution, 5%) had no effect on fertility and reproductive performance in male and female treated rats. Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421. For more information, go to www.Xiidra.com or call 1-800-828-2088. Marks designated ® and ™ are owned by Shire or an affiliated company. ©2018 Shire US Inc. SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates. Patented: please see https://www.shire.com/legal-notice/product-patents Last Modified: 01/2018 S33769 Rx Only Constructing continued from page 81

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