EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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28 EW NEWS & OPINION Not just continued from page 26 O'Brien tends to reserve this for more challenging cataract cases. "When the surgery is going to re- quire more manipulation, that's when the difluprednate is particu- larly attractive because of its greater potency," Dr. O'Brien said. Meanwhile, loteprednol is a de- signer steroid created by looking at prednisolone's side effects and work- ing backward to design a molecule to avoid these. "It truly has had fewer side effects," Dr. O'Brien said. It works on a corticosteroid mecha- nism, but it has a different chemical structure so it doesn't lead to a cataract. There has been some question whether it is as potent, however, as prednisolone. "I know that there is some published data that suggest equivalency, but I think for most of us in practice it is slightly less potent than pred but without the propen- sity to raise pressure as much," Dr. O'Brien said. He sees loteprednol as attractive for routine cataract surgery without any premorbid conditions. "It's po- tent enough to provide the addi- tional anti-inflammatory effect but with a safety profile that is desir- able," Dr. O'Brien said. This may be especially helpful for a younger pha- kic patient who may be on a steroid longer since it is less likely to cause a cataract or pressure spike. In fact, Dr. Trattler reserves this for patients with pressure issues or who are on a glaucoma medication. "The big advantage is that it works well for people who are more pres- sure sensitive," he said. 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 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®. NSAID protection Use of NSAIDs is also a vital part of the equation. "NSAIDs are impor- tant for protecting the retina, so they help us to prevent CME [cystoid macular edema]," Dr. Trattler said. In addition, they also help to alleviate pain. Dr. Trattler, who was part of the FDA clinical trial for Acuvail (ketoro- lac 0.45%, Allergan), sees this drug as offering good lubrication and packing a lot of punch. "It has got a carboxymethylcellulose, so it has a lubricating drop in it," he said. "It's indicated twice a day, and it gives about twice the levels of non- steroidals into the eye compared to standard Acular [Allergan], but it's safer because it has a lubrication part in it." Nevanac (nepafenac, Alcon), another ophthalmic NSAID, is less toxic to the ocular surface. "That has a pro-drug formulation that is uniquely designed to try and de- crease the toxicity of some non- steroidals that lead to the breakdown of the cornea," Dr. O'Brien said. The medication is bro- ken down into its active form by the enzymes that are present in the tear film and in the cornea. "As the drop is applied these hydrolases convert the nepafenac to amfenac, which is the active component of nepafenac," he said. Dr. O'Brien views this as a way to dose topically and have less ocular surface irrita- tion yet have a very potent drug in- side the eye. The company still provides ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA © 2011 Alcon, Inc. 3/11 NPF11500JAD some samples of Nevanac, just as it used to of prednisolone acetate be- fore the advent of Durezol, but Dr. O'Brien sees such samples as likely becoming obsolete. Ultimately given the expense of branded medicines, when potent antibiotics are needed, he thinks that it becomes a "Sophie's choice" for practitioners having to decide which branded medicine is most necessary. Bromday (bromfenac ophthalmic solution, ISTA Pharmaceuticals, Irvine, Calif.) offers an attractive dosing schedule. Dr. Trattler tends to use this more than Acular since it can be adminis- tered just once a day rather than twice for the latter. A new related NSAID dubbed Prolensa (bromfenac ophthalmic solution, ISTA Pharmaceuticals) is now under FDA consideration, ac- cording to Steven M. Silverstein, M.D., associate clinical professor, University of Missouri School of Medicine, Columbia, and Kansas City University of Medicine and Bio- sciences, Mo. "It's a new optimized formula that permits at least equal efficacy to once-daily bromfenac while lowering the concentration," Dr. Silverstein said. The idea is the less frequently patients need to take the drug, the better the patient com- pliance and the better it is for the ocular surface. Dr. Silverstein is optimistic. "The results of the phase III study were highly correlative to everything that we saw as a result of leading to the FDA approval of Bromday," he said. "It worked at least as well if not better at a lower concentration." The hope is that Prolensa will soon be available. "ISTA's plan is to apply for an NDA as early as possible in the first quarter of 2012," Dr. Silverstein said. "[The company] hopes to have products on the mar- ket either by the end of the year or the beginning of the following year." Also coming down the pike is the introduction of selective gluco- corticoid agonists (SEGRA). "These drugs are designed to share many of the favorable anti-inflammatory and immunomodulatory properties of classical glucocorticoid drugs but with fewer side effects," Dr. O'Brien said. "These appear very promising for providing that potency, but be- cause they have non-steroidal struc- tures, they don't have the negative effects of the steroids." EW Editors' note: Dr. O'Brien is an ad hoc non-salaried consultant for Alcon, Allergan, and Bausch + Lomb. Dr. Silverstein has financial interests with Alcon, Allergan, and ISTA. Dr. Trattler has financial interests with Alcon, Allergan, Bausch + Lomb, and ISTA. Contact information O'Brien: 561-515-1544, tobrien@med.miami.edu Silverstein: 816-358-3600, ssilverstein@silversteineyecenters.com Trattler: 305-598-2020, wtrattler@gmail.com February 2012