Eyeworld

June 2011 gotten along with a cataract in one eye, but now their second eye is starting to go. What job they do have they are about to lose because they can no longer see to do it. That's a story that's been consistent from patient to patient." With the help of some benevo- lent doctors, Mission Cataract is working to rewrite those stories. The program began in 1991 when Frederick A. Richburg, M.D., med- ical director, Valley Eye Institute, Fresno, Calif., and Sheree Petree, founder of the public relations firm Personalized Info-Media, collabo- rated to provide a day of free cataract surgery for those without insurance. In 1992, six California-based eye surgeons joined the effort, offering free surgeries statewide for eligible patients. A year later the program expanded nationwide, helping to provide free cataract surgery to roughly 10,000 people over its 20- year history. "Most of my clients were doc- tors, and I specialized in writing and printing patient information litera- ture and developing community service programs," explained Ms. Petree. "I closed Personalized Info- Media about 10 years ago after my husband passed away, but I contin- ued to manage and publicize Mission Cataract USA because there is such a need for vision impaired individuals to find help." Ms. Petree acts as the program's national coordinator and runs Mission Cataract, which she funds with her own money, from inside her home. "I talk to people all over the country who are desperate to see again," she said. "Their stories break my heart, and I try to connect them with participating Mission Cataract doctors who generously donate free cataract surgery. I am currently try- ing to obtain donations and grants to fund the program and help me re- cruit new doctors." Ms. Petree's goal is to have a Mission Cataract doctor in every state, but participation varies yearly as some practices drop out and oth- ers join. The South is especially in need of coverage, specifically Geor- gia, South Carolina, and Arkansas. Organizing such a big effort can seem daunting for doctors, so Mis- sion Cataract tries to make it as easy as possible on volunteer surgeons. After joining the program, partici- pants are given an instruction packet explaining step-by-step how to pro- ceed and recruit volunteers in their community. The packet includes a media kit consisting of press releases and public service announcements so the practice can effortlessly adver- tise the screening day. "Doctors get overwhelmed and their staff is busy," said Ms. Petree. "With the packet, they don't have to figure out how to contact the media, write a press release, and get the word out. We also provide financial questionnaires in English and Span- ish so doctors can determine if pa- tients meet the requirements." Surgeons have the freedom to choose a screening day that works for them, as well as a surgery day about a week later. But some doctors decide to tack on pro bono patients at the end of their regular surgery days to save on operating room costs. "When the program started, our vision was to have a Mission Cataract day across the country, the first Saturday in May," said Ms. Petree. "But that didn't work out for all of the doctors, so we changed the program to enable the doctors to do whatever day was best for their com- munity. The program is very flexible with different doctors doing it at dif- ferent times. Doctors do as many surgeries as they are able." Dr. Ingraham, for example, has completed 94 surgeries during his 6 years with Mission Cataract and ex- pects to do another 20 this year. Some doctors do only three or four cases yearly, others 60. "It's been a tremendously satis- fying experience, particularly on screening day when patients realize that we're going to take care of this at no charge to them," said Dr. Ingraham. "In many cases, they are crying. I think some come to the screening day thinking there's a catch. When they realize that's not the case, it is tremendously satisfy- ing to say, 'Yes, we are going to help you. Yes, we realize you have no ability to pay, and yes, that's OK.'" They may not be able to pay, but most patients want to say thank you any way they can. Dr. Ingraham has received tokens from patients ranging from homemade quilts to flower bouquets. Jim Spradley, a pa- tient of Dr. Richburg's, said thank you with a carousel horse, a gift to the doctor who gave him back the sight to finish carving it. "I am so inspired by the patients and their courage, not only to be getting along with their vision as bad as it is, but it would be very hard for me to go to someone and say, 'I really need this help,'" said Dr. Ingraham. "The fact that they can do that is remarkable." If you'd like to participate in Mission Cataract USA or make a do- nation, please visit www.mission cataractusa.org or email Sheree Petree at sheree@shereepetree.com. Contact information Ingraham: hingraham@geisinger.edu Petree: sheree@shereepetree.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. 315-25995 Bleed: XX.XX" x XX.XX" Trim: 2.125" x 12.5" Live: XX.XX" x XX.XX" CLIENT NAME: Abelson Taylor JOB#: VW120 DESC: Restasis OPERATOR: DL ROUND: 1 DATE: 02/14/2011 FILE NAME: VW120_b01.indd QC Check __________ __________ __________ Filling continued from page 69 Dr. Richburg and his wife, Linda Richburg, R.N., with Jim Spradley, a patient who showed his apprecation for restored sight by giving them a carousel horse that he had carved

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