EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/78712
April 2012 Practitioners reach their fill on new labeling vote by Maxine Lipner Senior EyeWorld Contributing Editor M.D., partner, Ophthalmic Consult- ants of Boston, said that patients' post-op courses are extremely varied. "Although the average number of days needed for resolution of post- op inflammation may be 16 or less, there is a significant percentage of patients who have a prolonged pe- continued on page 8 EW NEWS & OPINION 3 NEVANAC® (nepafenac ophthalmic suspension) 0.1%, topical ophthalmic Initial U.S. Approval: 2005 Revised: 9/2007 Source: Stockbyte/Stockbyte/Getty images Weighing use of same NSAID bottle in sequential eyes I t has been the status quo for many practitioners—having patients who are doing cataract surgery in quick succession use the same bottle of anti-inflam- matory drops for both eyes. The FDA Dermatologic and Ophthalmic Drugs Advisory Committee, how- ever, voted down a proposal that would allow such a bottle to be openly labeled for administration in both eyes in cataract procedures done within a few weeks of each other, according to Mark Packer, M.D., clinical associate professor of ophthalmology, Casey Eye Institute, Oregon Health & Science University, Portland, who was at the hearing on behalf of ASCRS. The FDA specifi- cally asked ASCRS to comment on this matter. There was dissent amongst panel members regarding the word- ing of the question itself, where several panelists felt the question should have been more specific to labeling. The panel took a vote on a revised version of the question: "Is it appropriate to label a single bottle of anti-inflammatory drops to treat both eyes post-operatively?" The panel voted 10-1 "No." Initially the vote against allow- ing this labeling for Bromday (ISTA Pharmaceuticals, Irvine, Calif.) was not even the issue—it was a question of safety. "Our contention is it's per- fectly safe; a lot of doctors are doing it now," Dr. Packer said. He said the FDA was under the impression that it was universal practice to always use separate bottles. The ASCRS Clinical Committee submitted a comment letter con- cluding that there was no evidence that the use of a single bottle of medication to treat two eyes follow- ing cataract surgery unnecessarily increases the risk of microbial infection. In response to this erroneous notion, EyeWorld conducted a survey to see what real world practices are for drops (see results on page 8). The FDA panel voted on the question of treating both eyes post- op with a single bottle: five mem- bers agreed this was appropriate, four disagreed, and two abstained. However, with regard to labeling of the bottles, practitioners did not gain the traction that they had hoped. Dr. Packer thinks that the issue was that there has never been a study done in which the same NSAID bottle has been used for both eyes. The vote was spurred by ISTA's request for a larger fill size for Bromday. Fill sizes for NSAIDs are currently all over the map. Ophthalmic burden This vote ties practitioners' hands in many cases. Bonnie A. Henderson, BRIEF SUMMARY 1 INDICATIONS AND USAGE NEVANAC® ophthalmic suspension is indicated for the treatment of pain and inflammation associated with cataract surgery. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing One drop of NEVANAC® should be applied to the affected eye(s) three-times-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. 2.2 Use with Other Topical Ophthalmic Medications NEVANAC® may be administered in conjunction with other topical ophthalmic medications such as beta-blockers, carbonic anhydrase inhibitors, alp ha-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-inflammatory 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-inflammatory 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-inflammatory 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 Effects 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 reflect 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 © 2011 Alcon, Inc. 3/11 NPF11500JAD