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lens growth, the circumlental space diminishes. Results have been encouraging. "At our FDA sites we're seeing a mean improvement of 2.91 lines of near acuity across all patients," Dr. Soloway said. "We've had up to seven lines of improvement." The technique, which doesn't affect dis- tance vision, is targeted mainly to- ward the emmetrope. "The younger 45- to 60-year-old age range with 20/20 uncorrected distance vision is our target group," he said. While position of the implants has been somewhat problematic, Dr. Soloway sees this as becoming a lot better controlled. "We're about to submit to the FDA to begin using newer disposable sclerotomes, which are a lot easier to handle and to get in the right place," Dr. Soloway said. He expects to complete enroll- ment in the FDA trial by the end of the year and to monitor the patients for the next 2 years. "We're looking at submitting to the FDA some time in 2013 or early 2014." The LaserACE procedure, mean- while, restores the plasticity of the sclera, according to Marguerite B. McDonald, M.D., F.A.C.S., clinical professor of ophthalmology, New York University Langone Medical Center, New York. "The sclera plays a very important role in the accom- modative process," Dr. McDonald said. "The zonules insert into the cil- iary processes, which are attached to the sclera." With this technique, a matrix of nine lesions - 600 microns spot size and 85-90% depth - in a patented di- amond pattern is made in four quadrants to partially ablate the sclera in a critical zone right over the ciliary body. "These lesions start back 0.5 mm from the limbus and are placed in the oblique quadrants to avoid contact with the extraocu- lar muscles," Dr. McDonald said. "Basically, it improves the resultant forces that the ciliary muscles have on the crystalline lens." AnnMarie Hipsley, D.P.T., Ph.D., founder, Ace Vision Group, and in- ventor of LaserAce, stressed that the goal here is not to change the globe. "The effect is one of increased plas- ticity rather than expansion, and no implants are required. The proce- dure is not designed to increase cir- cumlental space," she said. "Our technology is changing the biomechanical properties of the sclera, making it more plastic and increasing the efficiency of the cil- iary body and restoring the natural accommodative function without af- fecting refractive status," she said. Unlike scleral implants, the existing geometry of the globe is unaffected. Results have been promising. "Our results on almost 70 eyes out to 18 months show an average in- crease of accommodation of over 1.25 D, measured objectively with the i-trace system," Dr. Hipsley said. The most compelling result is that LaserACE data indicate an objective improvement in near and intermedi- ate vision with no loss of distance vision. In fact, with some latent hy- peropes, distance vision improved after the LaserACE procedure. Sheri L. Rowen, M.D., clinical assistant professor of ophthalmol- ogy, University of Maryland School of Medicine, Baltimore, and chief of ophthalmology, Mercy Medical Cen- ter, Baltimore, sees the procedure as helping to restore functional vision. Patients studied who were in the 40- 60 age range started with about 1.5 D of accommodation. "They got up to a little above 3 D, so they gained about 1.5 D, which isn't bad consid- ering that's what we give with the Crystalens (Bausch & Lomb, Rochester, N.Y.)," she said. "We all have a little bit of reserve and you include that and patients say, 'I can see J3 now—I can function.'" The laser is already 510(k) ap- proved and European Conformity marked. Dr. Hipsley is now focused on finishing international studies, where multi-year data indicate sta- bility of the procedure. A compre- hensive corroborative study is planned in Canada this year to pro- vide additional objective accom- modative data. Dr. Rick Potvin, Ace Vision's new chief scientific officer, is initiating a study of scleral biome- chanics and plasticity to help eluci- date the mechanism of action of the procedure. If the Canadian clinical data are confirmatory of earlier re- sults, Dr. Hipsley will use these to support an Investigational Device Exemption in a 3-year clinical study for the FDA approval of the proce- dure. EW Editors' note: Dr. Hamilton has no fi- nancial interests related to his com- ments. Drs. Hipsley, McDonald, and Rowen have financial interests with LaserACE. Dr. Krueger has a financial interest with LensAR. Mr. Musslewhite has a financial interest with Pixel Op- tics. Dr. Soloway has a financial inter- est with Refocus Group. Contact information Hamilton: hamillton@jsei.ucla.edu Hipsley: ahipsley@acevisiongroup.com McDonald: margueritemcdmd@aol.com Musslewhite: cmusslewhite@pixeloptics.com Krueger: krueger@ccf.org Rowen: srowen10@gmail.com Soloway: bds@ihateglasses.com PRESBYOPIA June 2011 ©2005, 2007 Alcon, Inc. 3/11 NPF11500JAD 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 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-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 The pioneer continued from page 44

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