Eyeworld

EW FEATURE 50 "You can separate very accu- rately down to 70 microns away from Descemet's membrane with your incision, and that's much bet- ter than we can do with the trephine," Dr. Price said. "The advantage of that is if you decide that you want to do a hand dissection instead of the big bubble, and if you get down to 80 microns or less from Descemet's membrane with a hand dissection, your results are essentially comparable to the big bubble technique because there's very little stroma there," he said. The zigzag incision allows sur- geons to get down very deeply with a hand dissection, giving them a good reference point, Dr. Price said. This is helpful because there are some patients in whom surgeons cannot get a big bubble to form, like those who have undergone radial keratotomy, he explained. The zigzag incision also allows a much better donor-recipient match than a straight vertical incision, Dr. Price said. With these incisions going down 70 microns to Descemet's, sur- geons can do these incisions and then a retrobulbar injection with a pressure-lowering device in the eye without the danger of rupturing the eye, which is pretty amazing, Dr. Price said. Not there yet Although the laser technology has brought significantly improved re- sults to DALK, it has a way to go in fulfilling its potential. Dr. Price said that cataract sur- geons are hooking femtosecond lasers up to optical coherence topog- raphy machines and to Scheimpflug imaging and other imaging systems so they can track the crystalline lens in the posterior part of the cornea. As that technology improves, Dr. Price said, then the lasers may fare better at the posterior surface of the cornea. "Another thing that the fem- tosecond laser can do to varying de- grees is make a track, which you can put a needle in and take it down next to Descemet's and give a more accurate rotation of where to start your injection of air to detach De- scemet's membrane," Dr. Price said. While that's not a standard pro- cedure on the machines, Dr. Price said that some companies are work- ing on it, and it should be available in the next year. The biggest drawback While anterior lamellar surgery has blossomed in the last 3-4 years, Dr. Price said, the United States faces a big hurdle—insurance coverage. Private insurance carriers are trying to refuse to pay for anterior grafts and especially deep anterior lamellar procedures, Dr. Price said. "They've come up with this idea that because it's a deep anterior lamellar, it's experimental and they don't have to pay. It's getting to be a real problem in the U.S., opting out of paying for things that are in the best interests of the patient," he said. This is probably going to be the biggest hurdle, and it's going to take the American Academy of Ophthal- mology and The Cornea Society working together to try to combat this with the insurance companies, Dr. Price said. EW Editors' note: Drs. Price and Steinert have financial interests with Abbott Medical Optics (Santa Ana, Calif.). Contact information Price: 317-814-2823, wendymickler@ pricevisiongroup.net Steinert: 949-824-0327, roger@drsteinert.com February 2011 CORNEA May 2011 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 Femtosecond continued from page 48

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