MAY 2013

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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Page 26 of 86

24 EW International May 2013 Battle-scarred continued from page 22 change," not least of all The Fred Hollows Foundation New Zealand, which also provided financial support for these studies. Currently, Ms. Clearly concurs that the backlog of cases requiring refractive error correction is being well addressed. "But with the surgical backlog, there are a number of barriers to this that we are working with the gov- ernment and other partners to overcome," she said. Among the barriers, this may be the largest: Timor-Leste only has one Timorese fully trained ophthalmologist—one, out of a population of 1.17 million. "In the 2010 RAAB, approximately 47,000 Timorese over the age of 40 were vision impaired, with cataract and refractive error responsible for about 90% of cases," Ms. LUMIGAN 0.01% AND 0.03% (bimatoprost ophthalmic solution) ® Brief Summary—Please see the LUMIGAN® 0.01% and 0.03% package insert for full Prescribing Information. INDICATIONS AND USAGE LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution) is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Pigmentation: Bimatoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as bimatoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of bimatoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution) can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. Eyelash Changes: LUMIGAN® 0.01% and 0.03% may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. Intraocular Inflammation: LUMIGAN® 0.01% and 0.03% should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated. Macular Edema: Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution. LUMIGAN® 0.01% and 0.03% should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. Angle-closure, Inflammatory, or Neovascular Glaucoma: LUMIGAN® 0.01% and 0.03% has not been evaluated for the treatment of angle-closure, inflammatory or neovascular glaucoma. Bacterial Keratitis: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Use With Contact Lenses: Contact lenses should be removed prior to instillation of LUMIGAN® 0.01% and 0.03% and may be reinserted 15 minutes following its administration. ADVERSE REACTIONS Clinical Studies Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In clinical studies with bimatoprost ophthalmic solutions (0.01% or 0.03%) the most common adverse reaction was conjunctival hyperemia (range 25%Ð45%). Approximately 0.5% to 3% of patients discontinued therapy due to conjunctival hyperemia with 0.01% or 0.03% bimatoprost ophthalmic solutions. Other common reactions (>10%) included growth of eyelashes, and ocular pruritus. Additional ocular adverse reactions (reported in 1 to 10% of patients) with bimatoprost ophthalmic solutions included ocular dryness, visual disturbance, ocular burning, foreign body sensation, eye pain, pigmentation of the periocular skin, blepharitis, cataract, superficial punctate keratitis, periorbital erythema, ocular irritation, eyelash darkening, eye discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, increases in iris pigmentation, conjunctival edema, conjunctival hemorrhage, and abnormal hair growth. Intraocular inflammation, reported as iritis, was reported in less than 1% of patients. Systemic adverse reactions reported in approximately 10% of patients with bimatoprost ophthalmic solutions were infections (primarily colds and upper respiratory tract infections). Other systemic adverse reactions (reported in 1 to 5% of patients) included headaches, abnormal liver function tests, and asthenia. Postmarketing Experience: The following reactions have been identified during postmarketing use of LUMIGAN® 0.01% and 0.03% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to LUMIGAN® or , a combination of these factors, include: dizziness, eyelid edema, hypertension, nausea, and periorbital and lid changes associated with a deepening of the eyelid sulcus. Cleary said. "The WHO guidelines recommend one mid-level eyecare personnel for every 25,000 people." Four additional expatriate ophthalmologists from China, Cuba, India, and Nepal are pitching in in Timor-Leste to plug the gap in care, Ms. Cleary said. Access to these ophthalmologists from remote areas continues to be an issue, so an ophthalmologist travels to one of TimorLeste's 13 districts each month. USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category C Teratogenic effects: In embryo/fetal developmental studies in pregnant mice and rats, abortion was observed at oral doses of bimatoprost which achieved at least 33 or 97 times, respectively, the maximum intended human exposure based on blood AUC levels. At doses at least 41 times the maximum intended human exposure based on blood AUC levels, the gestation length was reduced in the dams, the incidence of dead fetuses, late resorptions, peri- and postnatal pup mortality was increased, and pup body weights were reduced. There are no adequate and well-controlled studies of LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution) administration in pregnant women. Because animal reproductive studies are not always predictive of human response LUMIGAN® should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether LUMIGAN® 0.01% and 0.03% is excreted in human milk, although in animal studies, bimatoprost has been shown to be excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when LUMIGAN® is administered to a nursing woman. Pediatric Use: Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. Geriatric Use: No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. Hepatic Impairment: In patients with a history of liver disease or abnormal ALT, AST and/or bilirubin at baseline, bimatoprost 0.03% had no adverse effect on liver function over 48 months. OVERDOSAGE No information is available on overdosage in humans. If overdose with LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution) occurs, treatment should be symptomatic. In oral (by gavage) mouse and rat studies, doses up to 100 mg/kg/day did not produce any toxicity. This dose expressed as mg/m2 is at least 70 times higher than the accidental dose of one bottle of LUMIGAN® 0.03% for a 10 kg child. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility: Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 2 mg/kg/day and 1 mg/kg/day respectively (at least 192 and 291 times the recommended human exposure based on blood AUC levels respectively) for 104 weeks. Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests. Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day (at least 103 times the recommended human exposure based on blood AUC levels). PATIENT COUNSELING INFORMATION Potential for Pigmentation: Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution). Potential for Eyelash Changes: Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye during treatment with LUMIGAN® 0.01% and 0.03%. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment. Handling the Container: Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. When to Seek Physician Advice: Patients should also be advised that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physicianÕs advice concerning the continued use of LUMIGAN® 0.01% and 0.03%. Use with Contact Lenses: Patients should be advised that LUMIGAN® 0.01% and 0.03% contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of LUMIGAN® and may be reinserted 15 minutes following its administration. Use with Other Ophthalmic Drugs: Patients should be advised that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications. © 2012 Allergan, Inc., Irvine, CA 92612 ® marks owned by Allergan, Inc Patented. See: www.allergan.com/products/patent_notices Made in the U.S.A. Rx only APC70EN12 based on 71807US13. "I think our work here has been very beneficial, but I think there are other programs in countries such as Nepal that have also provided a lot of benefit to people; we're all learning from each other," Ms. Cleary said. Critical components to rolling out eye health success in TimorLeste include: • Using a nearly all Timorese workforce to strengthen sustainability of programs' impact, put patients at ease, and maintain a good working relationship with the government; • Supporting eyecare nurses and technicians in government-run eye clinics in remote areas; and • Creating awareness of screenings through prior promotional campaigns (even one evening ahead of time works by word-of-mouth). Meanwhile, Ms. Cleary said: "Timorese people seem to be very good at distinguishing between the things that the government and army of Indonesia did [during the conflict] and individual Indonesians. So we have an Indonesian optometrist on our training team, and he is able to work effectively here." There are remaining historical cultural challenges to overcome. "People here are terrified of operating theaters and hospitals," Ms. Cleary said. "They look like the places that the Indonesian army took Timorese people to be tortured. We often have patients who run away from the operating theater because they are afraid." To counter these fears, eyecare staff try to make surgery seem as friendly and welcoming as possible. "Patients can bring their family members into the operating theater as well, which helps to reduce fear," she said. That said, fear surrounding Timor-Leste seems to be ebbing drastically. With so much to work on, perhaps there's not enough time to be scared. "I was lucky enough to be here for the 10th anniversary of independence celebrations, which were very moving," Ms. Cleary said. More likely, there's real spirit within this new nation, affecting both locals and visitors alike, and it's pushing eyecare and, hopefully, other development in the right direction. EW Editors' note: Ms. Cleary has no financial interests related to this article. Contact information Cleary: lcleary@hollows.org.nz

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