Eyeworld

EW NEWS & OPINION November 2016 31 study of the Symfony done since 2012. … IOL exchanges should be unusual events with the Symfony. Long-term complaints of glare and halos should be rare events—on the visual sensations as a high quality monofocal, the Tecnis ZCB00, while providing the maximum possible near vision. The design goals were met and have been proven in every same order as a Tecnis ZCB00 and no more intense." Kenneth Lipstock, MD, Richmond, Virginia, weighed in and urged everyone to carefully read the FDA report, available at www.accessdata.fda.gov/cdrh_docs/ pdf/p980040s065b.pdf. He had detailed comments around specific data points in the FDA report that show why he is skeptical of the Symfony. In particu- lar, Dr. Lipstock noted the Symfony vs. monofocal control regarding halos in the FDA report: 8.8% vs. 1.4% were "bothered quite a bit," and 6.8% vs. 2.7% were "very both- ered." He also noted the feedback on starbursts: 8.8% vs. 1.4% were "bothered quite a bit" and 8.2% vs. 4.1% were "very bothered." Dr. Lipstock said, "Remember ReSTOR [Alcon, Fort Worth, Texas] was about 5% severe halos in its FDA study, and Crystalens also showed in the FDA study to have 5% severe halos. Now as I read this report it seems that Symfony is falling in the same boat." He encouraged careful study of the FDA data and wrote, "[T]he time we spend should include studying the scientific results others have laid out before us. Once we com- mit to providing these lenses, most surgeons will delve into a world of uncontrolled, anecdotal, biased results often to rationalize various motivations either conscious or subconscious. Our patients deserve critical thinking. "The FDA is not perfect, but they tend to force us to perform fair- ly well-done studies," Dr. Lipstock continued. "It's what we now have to help us evaluate the pros and cons of this new lens. Yes, we can get it in our hands and see up close how our patients do with it. Yes, it gives us another option that may have some advantages. But please let us try to look at the science-based evidence to help guide us forward." Dr. Waltz commented that with the results in the FDA report, "You can see the MTF [modulation transfer function] of the Symfony and Tecnis ZCB00 are identical and better than the ReSTOR. The con- trast sensitivity is nearly identical across a wide variety of cycles per degree suggesting a similar quality of vision between the two IOLs. … I stand by my statement that the Symfony achieved its design goals of maintaining a good quality of vision similar to the Tecnis ZCB00 INDICATIONS AND USAGE PROLENSA ® (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti-infl ammatory drug (NSAID) indicated for the treatment of postoperative infl ammation and reduction of ocular pain in patients who have undergone cataract surgery. IMPORTANT SAFETY INFORMATION ABOUT PROLENSA ® • PROLENSA ® contains sodium sulfi te, a sulfi te that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfi te sensitivity in the general population is unknown and probably low. Sulfi te sensitivity is seen more frequently in asthmatic than in non-asthmatic people. • All topical nonsteroidal anti-infl ammatory drugs (NSAIDs), including bromfenac, may slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. • There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac. Use with caution in patients who have previously exhibited sensitivities to these drugs. • There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. Use with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. • Use of topical NSAIDs may result in keratitis. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac, and should be closely monitored for corneal health. 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. Post-marketing experience with topical NSAIDs suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events. • PROLENSA ® should not be instilled while wearing contact lenses. The preservative in PROLENSA ® , benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA ® . • The most commonly reported adverse reactions in 3%-8% of patients were anterior chamber infl ammation, foreign body sensation, eye pain, photophobia, and blurred vision. Please see brief summary of full Prescribing Information for PROLENSA ® on adjacent page. References: 1. PROLENSA Prescribing Information, April 2013. 2. Data on fi le, Bausch & Lomb Incorporated. 3. Baklayan GA, Patterson HM, Song CK, Gow JA, McNamara TR. 24-hour evaluation of the ocular distribution of (14)C-labeled bromfenac following topical instillation into the eyes of New Zealand white rabbits. J Ocul Pharmacol Ther. 2008;24(4):392-398. PROLENSA is a registered trademark of Bausch & Lomb Incorporated or its affi liates. © Bausch & Lomb Incorporated. All rights reserved. Printed in USA. PRA.0188.USA.15 The PROLENSA ® Effect POWERED FOR PENETRATION Advanced Formulation to Facilitate Corneal Penetration 1-3 pH e ffect Hal og en a ti on e ffect PROLENSA ® delivers potency and corneal penetration with QD dosing at a low concentration 1-3 continued on page 32

• Blank Page
• Blank Page (1)