Eyeworld

May 2011 Always on the lookout for ways to develop the high-tech image of his practice for the best patient ex- perience, Dr. DeBry said that when he was introduced to the Doctor App, he immediately saw the poten- tial benefits of having this applica- tion installed on as many patients' and referring doctors' phones as he could. Setting it up Physicians can build their own Doc- tor App at www.yourdoctorapp.com for the introductory price of $999 (plus $34.99 per month for mainte- nance). Once purchased, the physi- cian gets a username and password that allows him or her to log on to the website and enter all the content he or she wants to include in the in- dividualized app. Cloud Nine then creates the app and within a week, it's submitted to Apple Inc. for the iPhone and Google for android phones. Apple takes 10-14 days to approve it, while on Google, the app goes live immediately without any approval process. Any amendments or additional information can be submitted on the go, and the app automatically updates itself in real time. Despite an earlier launch, Cloud Nine officially put the Doctor App on the market January 1. Since then, Dr. Shah said, there have been about 35 people who have bought the Doctor App to build; 25 of these are already available for free download. Dr. Feldman said, "Since setting up the Philly Eye App, which was quite simple, we've been impressed by the hundreds of times that our app has been downloaded. We be- lieve that the app is another way for our practice to stay fresh in the minds of our patients and reflects how we remain innovative in this rapidly changing field." Future enhancements For now the app has only one lay- out, but Dr. Shah said in the near fu- ture there will be different icons and backgrounds to choose from when doctors are building their apps. "We may provide three or four themes that the doctor can pick from. Ideally we want to come to the point where the icons and lan- guage are all customizable," he said. There are several other features Cloud Nine wants to add to the app. Among them, a calendar feature with a medicine dose alarm to help with patient compliance and push notifications so that the user will be immediately alerted to any recent updates. EW Editors' note: Dr. Shah is a co-founder of Cloud Nine Development. Drs. Feldman and DeBry have no financial interests in the product mentioned. Contact information Shah: 785-218-8669, drvinayshah@gmail.com, RESTASIS ® (cyclosporine ophthalmic emulsion) 0.05% Sterile, Preservative-Free INDICATIONS AND USAGE RESTASIS ® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti- inflammatory drugs or using punctal plugs. CONTRAINDICATIONS RESTASIS ® is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. WARNING RESTASIS ® ophthalmic emulsion has not been studied in patients with a history of herpes keratitis. PRECAUTIONS General: For ophthalmic use only. Information for Patients 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. Do not allow the tip of the vial to touch the eye or any surface, as this may contaminate the emulsion. RESTASIS ® should not be administered while wearing contact lenses. Patients with decreased tear produc tion 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. Carcinogenesis, Mutagenesis, and Impairment of Fertility 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 significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly 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 significantly 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 1000 and 500 times greater, respectively, than the daily human dose of one drop (28 µL) of 0.05% RESTASIS ® BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. Cyclosporine has not been found mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronu cleus 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). 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 15,000 times the human daily dose of 0.001 mg/kg/day) for 9 weeks (male) and 2 weeks (female) prior to mating. Pregnancy-Teratogenic Effects Pregnancy category C. Teratogenic Effects: No evidence of teratogenicity was observed in rats or rabbits receiving oral doses of cyclosporine up to 300 mg/ kg/day during organogenesis. These doses in rats and rabbits are approximately 300,000 times greater than the daily human dose of one drop (28 µL) 0.05% RESTASIS ® BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. Non-Teratogenic Effects: 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 30,000 and 100,000 times greater, respectively than the daily human dose of one-drop (28 µL) of 0.05% RESTASIS ® BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal tox icity 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 17,000 and 30,000 times greater, 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 post partum, a maternally toxic level, exhibited an increase in postnatal mortality; this dose is 45,000 times greater than the daily human topical dose, 0.001 mg/kg/day, assuming that the entire dose is absorbed. No adverse events were observed at oral doses up to 15 mg/kg/day (15,000 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 efficacy 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. ADVERSE REACTIONS The most common adverse event following the use of RESTASIS ® was ocular burning (17%). Other events 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). Rx Only Based on package insert 71876US14B Revised February 2010 ©2010 Allergan, Inc. Irvine, CA 92612, U.S.A. ® marks owned by Allergan, Inc. APC80OW11 U.S. Patent 5,474,979 Made in the U.S.A. The Doctor continued from page 73 Registration and Housing Now Open! Save the Date Back in 2012 Administrator Program Track With Expanded Program

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