Eyeworld

EW ASCRS PREVIEW 37 "While Harvard has acknowl- edged that other universities have banned industry support for CME, its policy is to continue to accept in- dustry funding and continue to en- courage full disclosure on the part of the recipients," Dr. Lindstrom said. The latter half of his lecture will focus on the impact the U.S. regula- tory process has on the innovation cycle, he said. Medical research and development generates about 360,000 jobs directly and millions more indirectly, he said. Although the FDA boasts its average time from submission to approval of 510(k) submissions is 5 months, a Stanford University study showed the time from submission to approval is closer to 41 months; in Europe the same submission takes only 7 months from first communication to certificate. Likewise, the same study found the FDA claiming 9 months from filing to approval for PMA submissions, but industry re- ports at least 54 months (compared to just 11 in Europe). Coupled with the extra costs as- sociated with filing, Dr. Lindstrom hopes the pendulum "will start to swing back the other way," with lowered costs and quicker approval times. He plans to discuss some of his thoughts on that topic as well. Each year, ASCRS awards the In- novator's Medal to an individual whose innovative ideas have bene- fited ophthalmologists and their pa- tients. The lecture and medal were established in 1985; its recipients in- clude some of the world's most prominent pioneers in ophthalmic surgery. ASCRS renamed its Innova- tor's Lecture to the Charles D. Kel- man Innovator's Lecture in 2002 in recognition of his lifelong contribu- tions and innovations that have benefited patients and advanced the science of ophthalmology. This year's Innovator's Session will be presented on Monday, March 28, from 10:00 to 11:45 a.m. EW Contact information Lindstrom: 952-567-6051, rllindstrom@mneye.com A drop with low dropout COVERAGE 2011 No change in formulary status expected Prescribe LUMIGAN ® 0.01% effi cacy with low discontinuation 1 For patients starting or changing PGA therapy, consider… Indication: 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. Important Safety Information Warnings and Precautions: Pigmentation: Bimatoprost ophthalmic solution has been reported to cause changes to pigmented tissues: most frequently, increased pigmentation of the iris, eyelid, and eyelashes. Increases are expected as long as bimatoprost is administered. Iris color change may not be noticeable for several months to years. After discontinuation of bimatoprost, iris pigmentation is likely to be permanent, while eyelid and eyelash changes have been reported to be reversible in some patients. Patients should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known. Intraocular Inflammation: LUMIGAN ® 0.01% and 0.03% should be used with caution in patients with active intraocular inflammation (eg, 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. Adverse Reactions: In clinical studies with bimatoprost ophthalmic solutions (0.01% or 0.03%), the most common adverse event was conjunctival hyperemia (range 25%-45%). Approximately 0.5% to 3% of patients discontinued therapy due to conjunctival hyperemia with 0.01% or 0.03% bimatoprost ophthalmic solutions. Other common events (> 10%) included growth of eyelashes and ocular pruritus. Please see brief prescribing information on adjacent page. 1. LUMIGAN ® 0.01% and 0.03% Prescribing Information. Visit us at www.lumigan.com ©2011 Allergan, Inc., Irvine, CA 92612 ® marks owned by Allergan, Inc. APC50EX11 107999 Tue Jan 18 23:38:40 PST 2011 - 011811-4_10x13_4C.ps LUMIGAN ® 0.01% AND 0.03% (bimatoprost ophthalmic solution) 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 pigmen- tation 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 (eg, 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 pseudo- phakic 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, inflam- matory, 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 event was conjunctival hyperemia (range 25%-45%). Approximately 0.5% to 3% of patients discontinued therapy due to conjunctival hyperemia with 0.01% or 0.03% bimatoprost ophthalmic solutions. Other common events (> 10%) included growth of eyelashes and ocular pruritus. Additional ocular adverse events (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, eyelid erythema, ocular irritation, eyelash darkening, eye discharge, tearing, photophobia, allergic conjunc- tivitis, 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 events reported in approximately 10% of patients with bimatoprost ophthalmic solutions were infections (primarily colds and upper respiratory tract infections). Other systemic adverse events (reported in 1% to 5% of patients) included headaches, abnormal liver function tests, and asthenia. 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 that 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 pigmen- tation 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/m 2 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 physician's 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: If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications. © 2010 Allergan, Inc., Irvine, CA 92612 ® marks owned by Allergan, Inc APC26XC10 based on 71807US11X. Rx only 011811-4_7x10_PI.pgs - Tue Jan 18 23:37:09 PST 2011 An ophthalmologist's continued from page 35

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