Eyeworld

January 2011 by Vanessa Caceres EyeWorld Contributing Editor Advancing genetic eye disease research NEI program helps vision researchers, clinicians, and patients A s the study of genetics and medicine grows, the National Eye Institute (NEI), Bethesda, Md., of- fers a service to help vi- sion researchers, clinicians, and patients better understand inherited eye diseases. The National Ophthalmic Dis- ease Genotyping Network, or eye- GENE for short, facilitates research into genetic causes of ocular diseases and provides free genotyping to pa- tients with inherited eye diseases. "Our purpose is to foster and support research for the genetic causes of different ophthalmic disor- ders," said Kerry Goetz, M.S., eye- GENE coordinator, NEI, National Institutes of Health, Bethesda. eyeGENE research covers ap- proximately 30 inherited ocular dis- eases, including aniridia, glaucoma, Leber hereditary optic neuropathy, and retinoblastoma. Patients who enroll in eyeGENE via their health providers get free di- agnostic genotyping by a Clinical Laboratory Improvement Amend- ments (CLIA)-approved lab; in ex- change, the patients agree to let their eye exam and blood test results be available to vision researchers in the near future. When the samples that are part of the eyeGENE data- base become available to vision re- searchers, they may use them in clinical trials to find further links be- tween specific genes and diseases and to identify future treatments. More than 400 genes have been identified that contribute to inher- ited eye diseases, according to an eyeGENE brochure. EyeGENE was started to help patients receive clini- cal diagnoses and to find out if treat- ments under development for © 2010 Alcon, Inc. 10/10 NPF10504JAD ® NEVANAC® (nepafenac ophthalmic suspension) 0.1%, topical ophthalmic Initial U.S. Approval: 2005 Revised: 9/2007 BRIEF SUMMARY 1 INDICATIONS AND USAGE NEVANAC® ophthalmic suspension is indicated for the treatment of pain and inammation associated with cataract surgery. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing One drop of NEVANAC® should be applied to the aected eye(s) three-times-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the rst 2 weeks of the postoperative period. 2.2 Use with Other Topical Ophthalmic Medications NEVANAC® may be administered in conjunc- tion with other topical ophthalmic medica- tions such as beta-blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics. 3 DOSAGE FORMS AND STRENGTHS Sterile ophthalmic suspension: 0.1% 3 mL in a 4 mL bottle 4 CONTRAINDICATIONS NEVANAC® is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other NSAID. 5 WARNINGS AND PRECAUTIONS 5.1 Increased Bleeding Time With some nonsteroidal anti-inammatory drugs including NEVANAC®, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that NEVANAC® ophthalmic suspension be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. 5.2 Delayed Healing Topical nonsteroidal anti-inammatory drugs (NSAIDs) including NEVANAC®, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. 5.3 Corneal Eects Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs including NEVANAC® and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post surgery may increase patient risk and severity of corneal adverse events. 5.4 Contact Lens Wear NEVANAC® should not be administered while using contact lenses. 6 ADVERSE REACTIONS 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 the rates in the clinical studies of another drug and may not reect the rates observed in practice. 6.1 Ocular Adverse Reactions The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These events occurred in approximately 5 to 10% of patients. Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment. Some of these events may be the consequence of the cataract surgical procedure. 6.2 Non-Ocular Adverse Reactions Non-ocular adverse reactions reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting, and sinusitis. See full prescribing information for NEVANAC®. ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA © 2007, 2008 Alcon, Inc.

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