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Cedarsaspens.org

Volume: 1 Issue: 1 Winter 2016
HOT TOPICS
FROM THE 5th ANNUAL CEDARS/ASPENS met at the iconic Fontainebleau Hotel in Miami Beach, Florida, during the Society's 5th Annual I•C•E Conference. The 4-day event, which spanned from December 10 to 13, 2015, was attended by CEDARS/ASPENS members and ophthalmic industry exhibitors and attendees. The organization's goals of innovation, collaboration, and education were strongly demonstrated throughout the Conference. The daily academic sessions concentrated on presentations, followed by vigorous and sometimes controversial panel discussions, the topics of which included Challenging Cases and Controversies in Cataract, Refractive, and Cornea; External Disease: Hot Topics Case Debates; Glaucoma; The Business of Dry Eye; and Practice Management Game Changers. The presenters discussed and debated various "This unique and intimate format brought together leaders from approaches to challenging patient problems and the pros and cons of different surgical interventions, among other things. The around the country to openly discuss conventional and alternative discussions were open to comment by all conference attendees. techniques for handling complex cases. In addition, the low industry The format facilitated valuable exchanges of experience from executive-to-surgeon ratio fostered a progressive and collaborative which all could benefit. atmosphere, leading to innovative and forward-thinking discussions," said Robert Weinstock, MD, Director of Cataract and Refractive Services at The Eye Institute of West Florida and The Weinstock Laser Eye Center. Kenneth Beckman, MD, Clinical Assistant Professor of Ophthalmology at The Ohio State University and Director of Corneal Services at Comprehensive EyeCare of Central Ohio in Westerville, Ohio, also emphasized the importance of the interaction of industry and surgeons: "Our Annual Conference facilitates expansion and dissemination of knowledge among peers and promotes excellent patient care through the give-and-take of experiences." Sheri Rowen, MD, Clinical Assistant Professor of Ophthalmology CEDARS/ASPENS Members at the 5th Annual CEDARS/ASPENS I•C•E at University of Maryland, Baltimore, Maryland, and in private Conference in Miami Beach, Florida practice at NVision EyeCenters of Newport Beach, Newport Numerous opportunities were available for industry Beach, California, added to this, saying, "The CEDARS/ASPENS representatives to bring the surgeons up to speed on their Annual Conference is an opportunity to bring together leaders in latest technologic advances during the Conference's Industry ophthalmology, with the goal of shaping ophthalmic practice for both Interface Sessions.
men and women through the exchange of ideas and best practices." Volume: 1 Issue: 1 ‘BOLD NEW ALLERGAN' EXPANDS
COMMITMENT TO EYE CARE
Strong ophthalmic pipeline, proposed Pfizer link, will enhance
customer and physician support
Active engagement with leading ophthalmic surgeons will play a critical role as global pharmaceutical company Allergan strengthens its commitment to eye care, asserts Dave LeCause, Vice President for US Eye Care Sales and Marketing. Following the firm's successful combination with Actavis last March, Allergan has 17 eye care programs in middle- to late-stage development. Among these are new pharmaceuticals and devices targeting dry eye, glaucoma, and retinal diseases.
"Allergan has a long and robust history of innovation that has produced a market-leading eye care portfolio. We have introduced entirely new drug categories like alpha agonists in glaucoma and RESTASIS® in dry eye. But we would not have had any success without the great partnerships we have built with patients and doctors in the eye care community," LeCause says.
Contracting with insurance plans and formularies so that the right Working closely with practicing clinicians and thought leaders eye care is available at a reasonable out-of-pocket cost is one element. is part of Allergan's "Open Science" development model, Another is targeted patient support, such as the RESTASIS® My which also includes in-house R&D and outreach to academic Tears, My Rewards® Program. It features money-saving refills, a customer researchers, venture-capital-backed entrepreneurs and startups, service hotline, and an iPhone® app with twice-daily dosing reminders. LeCause explains. "We are constantly evaluating new options. "Making sure patients get the right support so they can continue to This multidimensional approach gives us the flexibility to benefit over time is a real priority," LeCause says.
continue innovating in the eye care space. We are agnostic on where good ideas come from." Supporting patients also means supporting clinical practices. Through its TechAlliance program, Allergan provides staff New products …
training in eye disease basics and practical tools, such as assessment Over the next few years Allergan will focus primarily on dry eye, questionnaires and a Smartphone app that helps answer patient glaucoma, and retina, according to LeCause. He expects 5 or 6 questions. TechAlliance also supports patients with downloadable new dry eye products, including RESTASIS® in a preservative- coupons, videos on taking eye drops, and medication diaries. "It free, multidose bottle. "This offers convenience to patients and will make a strong dry eye therapy even more attractive." enhances service at the point of care. Patient benefit is what it is all about," emphasizes LeCause.
With its July acquisition of Oculeve, Allergan also plans a dry eye device. Clinical trials show the noninvasive nasal Pfizer and the future
neurostimulator increases tear production, and Allergan expects Allergan's recent mergers and acquisitions are elements of a a US Food and Drug Administration submission this year. "Our "Growth Pharma" strategy. "The goal," says LeCause, is gathering approach is to build out a portfolio of options for clinicians to and harnessing the resources not only to innovate in an increasingly best treat patients," states LeCause.
dynamic, competitive, and technically demanding market, but also to meet growing patient needs worldwide.
For glaucoma, Allergan plans to build on its successful ALPHAGAN®, LUMIGAN®, and COMBIGAN® eye drops "Allergan's proposed combination with biopharmaceutical giant with extended-release drug delivery technologies and the recently Pfizer is the next step," LeCause adds. "It will create an extremely acquired AqueSys XEN® Gel Stent. "We see the glaucoma powerful biopharmaceutical company that will allow us to make a market going beyond topical treatment to dropless therapy difference on a much larger scale. We will have a presence in more and world-class MIGS. The line between pharmaceuticals than 180 countries, and will be able to provide a lot of benefit that we and devices is blurring, and we want to be the market leader. wouldn't have been able to as a stand-alone organization." We don't care if it is a surgical or new drug delivery device or extended-release drops; if it is a valid therapeutic option in an area in which we have strength and if it is unique and we can Pfizer's vast resources and global reach will also help Allergan attract differentiate it, we want to bring it to market." top talent and further strengthen its position with what LeCause believes is the industry's strongest eye care R&D pipeline.
… and new supports for patients and staff
"But even the best therapy gives no benefit if patients can't LeCause maintains, "The bold new Allergan is stronger and more access it," LeCause points out. Allergan is growing access committed than ever to the eye care community. We will continue programs that help patients to not only start new therapies, but to bring considerable resources to eye care and I know we will also to adhere to them over time.
accomplish a lot together." Volume: 1 Issue: 1 SHIRE IN OPHTHALMICS
A new sponsor of the CEDARS/ASPEN Society and a new entrant in ophthalmics, Shire is a leading global biotech company headquartered in Lexington, MA, and Zug, Switzerland. The company has a 30-year history of developing innovative medicines for patients with rare diseases and specialty conditions, in areas including neuroscience, gastrointestinal medicine, and internal medicine. Shire's CEO, Flemming Ornskov, MD, hinted at the rationale for entering into ophthalmics in a recent interview – "We like small and specialized spaces and we count ophthalmology to that," Ornskov said. "We think there is a significant innovation vacuum for someone who truly focuses on the patient aspects of ophthalmology." When entering a new therapeutic area, Ornskov has said that Shire's goal is to "become one of the top three companies in that arena," achieved primarily by bringing innovation to areas of unmet need. Based on that statement, perhaps it's not surprising that in just over two years, Shire has already made enormous progress in retinitis pigmentosa, and infectious conjunctivitis. Now the company achieving that goal by focusing on key areas: is focused on moving these assets forward, always focused on the unmet medical needs of patients with ophthalmic diseases.
• Shire's pipeline and products
• The people Shire hires
• Shire's promise to the eye care community
Shire has made some impressive hires in the ophthalmics space, with most of the team in marketing, medical, research and development, all PIPELINE AND PRODUCTS
the way up to the CEO, having significant eye care experience. However, When it comes to pipeline and product development in Shire's hiring philosophy doesn't just focus on technical expertise. With ophthalmics, this is where Shire's long history of drug a focus on acting more like a biotech with the resources of large pharma, development comes into play. Approximately 20% of the Shire's ophthalmics hires are also entrepreneurial spirits – individuals workforce is solely dedicated to R&D activities, and that who are both committed to supporting research and development of dedication is focused on the development of innovative therapies new products to meet unmet needs, and who are determined to make a for patients with unmet needs. difference in the lives of patients and their caregivers.
Philip Vickers, PhD, Global Head
Monica Roy, OD, MPH, Director of Clinical
of Research & Development, Shire
Development in Ophthalmology, Shire
"Our commitment to ophthalmology is an excellent "I came to Shire knowing that they had just started fit for our organizational strengths" says Phil in ophthalmics, but instead of seeing risk, I just saw Vickers, PhD, Head of Research and opportunity. There are so many unmet medical needs in this Development at Shire. "Firstly, we have space - in diseases as diverse as dry eye, acute conjunctivitis, extensive ophthalmics talent and experience in- and glaucoma - that the opportunity to join a company that house, which is critical to driving internal R&D programs in ophthalmics was truly patient-centric seemed like a perfect fit. In ophthalmics, the possibilities are forward and assessing external opportunities; secondly, we've instilled endless; you just need to be in a company committed to making a difference." a culture of innovation at Shire consistent with moving forward novel therapies focused on the needs of ophthalmology patients; and thirdly, we are A PROMISE TO THE COMMUNITY
experts at establishing creative partnerships that further drive the success of Shire recognizes no company can deliver on a promise of developing our pipeline. Our recent agreement with the Foundation Fighting Blindness medicines in therapeutic areas of high unmet needs without strong (FFB) to research a novel treatment for autosomal dominant retinitis and sustainable relationships with professional and advocacy pigmentosa is a perfect example of this." organizations. Collaborations with the CEDARS/ASPENS Society and others are essential to advancing the field and to urgently Using the multifaceted approach of in-house discovery, addressing some of the many unmet needs that still exist in strategic acquisitions, and creative partnerships, Shire has already established a comprehensive pipeline in ophthalmics, including investigational compounds for dry eye disease, To learn more about Shire's philosophy and commitment to retinopathy of prematurity, glaucoma, autosomal dominant ophthalmics, visit www.shire.com.
Volume: 1 Issue: 1 "With proper attention to maintaining an absolutely stable capsule, anterior capsule tears can be managed safely, allowing for toric or multifocal IOL placement with excellent postoperative results," Dr Raviv emphasized.
Despite cataract surgery being one of the oldest ocular surgeries performed, advances in technologies and the ability to address Omidria: Prevention May Be the Best Cure
cases that are far more complex than a simple soft cataract The jury seems to be leaning in favor of phenylephrine and removal not only allow surgeons to raise the bar in achieving ketorolac injection, 1%/0.3% (Omidria, Omeros Corporation), as superior postoperative vision, but also present surgeons with the standard-of-care drug in routine and challenging cataract cases complex scenarios that often have them stretching the limits of to prevent miosis. The formulation is a combination of an alpha-1 their creativity to achieve the desired outcomes. The following adrenergic receptor agonist and a nonsteroidal anti-inflammatory cases are just a few of those presented at the conference.
drug added to the irrigation solution before intraocular use.
Managing an Anterior Capsular Tear
"The number one cause of problems in my cataract cases is Tal Raviv, MD, Associate Clinical Professor of Ophthalmology, maintaining the pupillary size," Robert Weinstock, MD, commented. New York Eye and Ear Infirmary of Mount Sinai, Icahn School While he likes the Malyugin ring, there is always a question about of Medicine at Mount Sinai, tackled the case of a 60-year-old whether or not the ring should be inserted and at what point patient who underwent planned toric intraocular lens (IOL) intraoperatively. implantation during femtosecond laser-assisted cataract surgery. However, an anterior capsular (AC) tear developed after Over time, Dr Weinstock has become increasingly impressed with phacoemulsification and before irrigation/aspiration (I/A). the idea of using Omidria routinely during cataract surgeries; a side-by-side comparison of the surgical videos of the eyes of a "A tear is a warning shot over the bow for complications," he said.
patient who used tamsulosin hydrochloride (Flomax, Boehringer Ingelheim Pharmaceuticals, Inc) showed why. The patient had floppy Interestingly, AC tears were ubiquitous in the can-opener iris syndrome and underwent cataract surgeries 1 week apart with capsulotomy/extracap period, when they rarely progressed Omidria used in 1 eye but not in the other. In the eye without Omidria, to posterior capsular (PC) tears. However, when phaco the pupil began to contract, but the fellow eye remained markedly and pressurized chambers were introduced, most surgeons more stable. "The impact of the continuous irrigation of the eye with experienced increased occurrences of PC extensions. A the medication was very obvious," Dr Weinstock emphasized.
literature review of AC tears reveals 2 studies, one from 2006 (Marques F, et al. J Cataract Refract Surg. 2006;32[10]:1638- Dr Weinstock uses Omidria as much as possible in his practice to 1642) and another from 2015 (Carifi G, et al. Am J Ophthalmol. prevent any unforeseeable pupillary issues. The biggest take-home 2015;159[3]:463-469), that reported 48% and 24%, respectively, message for him is that the drug makes a huge difference in his rates of progression to PC ruptures. "While surgeons have patients and prevents the cascade of events that might otherwise improved, we can still do better," Dr Raviv said.
occur if the drug is not used.
The cost of the drug can be approximately $400 for each patient. "This situation calls for immediate countermeasures to prevent However, while financial considerations are important, Dr Weinstock posterior tear extension. The surgeon's next steps must maintain remains patient focused. "We have to think of what is best for our planar positioning of the capsule, preventing any trampolining, patients, regardless of cost," he emphasized. Omeros provides a by ensuring constant anterior chamber pressurization," he said. comprehensive and helpful reimbursement assistance program. For cortical cleanup in the presence of AC tears, Dr Raviv The Unmeasurable Cataract:
advises performing gentle I/A under a viscoelastic, leaving the Shooting the Moon With ORA
area of the tear last. He uses the soft silicone sleeved capsular P. Dee Stephenson, MD, Associate Professor, University of South guard (Bausch & Lomb) with gentler I/A flow settings. To Florida, Tampa, President of the American College of Eye maintain chamber stability, he fills the eye with a viscoelastic Surgeons, and in private practice at Stephenson Eye Associates in before withdrawing I/A. A 1-piece acrylic IOL is then inserted Venice, Florida, described the case of a 67-year-old woman with gently into the capsular bag. In the case under discussion, the bilateral mature cataracts. The left and right eye visual acuity (VA) trailing haptic opened prematurely during insertion and required levels were, respectively, counting fingers at 2 feet and hand motions; more manipulating than usual to ensure its proper positioning. the patient had not been able to read in 7 years. The keratometry After the IOL is positioned, the incisions are hydrated before values were similar in both eyes; the white-to-white measurements the viscoelastic is removed and hydration is repeated. Finally, were 12.3 millimeters. The axial lengths were unmeasurable with a watertight closure is ensured postoperatively with a wound 2 different A-scan ultrasonography machines, and no B-scan was sealant such as ReSure (Ocular Therapeutix, Inc). available. However, the patient had no history of eye disease. Volume: 1 Issue: 1 Dr Stephenson has used the Optiwave Refractive Analysis was negative for infiltrates. Steroid treatment resulted in slight (ORA) System with VerifEye+ technology (Alcon, Inc) in almost improvement. Two weeks later, the patient reported sudden pain all her cases as well as in unusual cases, but the technology and a "gush of fluid" from the eye while driving. An examination requires keratometry values and axial length measurements to showed a small corneal perforation, which Dr Talley Rostov glued, calculate IOL powers, making this case very interesting. The and a successful corneal transplant was performed 2 days later. The degree to which ORA can be trusted in an unusual case of this postoperative course was normal and the visual acuity was good. magnitude was the question to be answered. However, the histopathologic evaluation following transplantation showed the presence of Acanthamoeba, she recounted. Dr Stephenson inputted her keratometry values and chose an average axial length of 24 millimeters based on the average The eye remained quiet, but the question arose about the appropriate measurements and ocular appearance. The ORA determined treatment regimen. The options included steroids, treatment with that a 21.5-diopter lens should be implanted. Postoperatively, in an Acanthamoeba medication before steroidal treatment, or a triple the first eye, the patient had 20/25 uncorrected VA, a refraction therapy of polyhexamethylene biguanide (PHMB)-hexamidine, of -0.5 diopter (20/20), an uncorrected near VA of J6, and a chlorhexidine, and combination bacitracin/neomycin/polymyxin 2.0+ add yielded J1. Dr Stephenson later treated the second eye (Neosporin, Johnson & Johnson). However, the chances were small of the same way with the same great results. the graft remaining clear for any length of time. "The ORA IOL power is proprietary. It is a modified version Dr Talley Rostov opted for a double therapy of topical PHMB and of the refractive vergence formula that incorporates the chlorhexidine and a low-dose steroid. Two weeks later, the patient measured aphakic spherical equivalent as one of the primary variables. Its calculation for effective lens position includes a presented with pain and an epithelial defect. At this point, Dr Talley lens constant and 4 regression coefficients that are associated Rostov increased the doses of PHMB and chlorhexidine and added with specific anatomic features of the individual eye being Refresh PM (Allergan, Inc) and the steroid was instilled twice daily. measured. For me, ORA with VerifEye+ has helped eliminate The epithelial defect began to resolve. almost all outliers. It has raised the bar in my practice for great outcomes," Dr Stephenson stated.
Three weeks later, an infiltrate formed inferiorly, the graft appeared compromised, and the epithelial defect increased. Dr Talley Rostov stopped the steroid, increased the doses of the other drugs, and added oral and topical voriconazole to the regimen. KEY TO TREATING THE
PERSISTENT OCULAR PATHOGEN:
The graft ultimately failed and cultures were positive for Staphylococcus aureus and Acanthamoeba. Dr Talley Rostov then performed a therapeutic penetrating keratoplasty (TPK) and added topical vancomycin and a fluoroquinolone to the regimen.
Cases of Acanthamoeba keratitis are rare, difficult to diagnose, and even more difficult to treat because there is no established "A learning point here is that in Acanthamoeba cases, the risk of a treatment. Steroid therapy seems to be controversial and may secondary infection is high," she emphasized.
worsen the clinical picture.
A 68-year-old ophthalmologist had a complicated ocular Following the second TPK, the eye continued to have a nonhealing history that included radial keratotomy in an unusual pattern, epithelial defect. Grafting of amniotic membrane failed and the eye followed by LASIK about 7 years later and possibly hex K ultimately was lost. and automated lamellar keratoplasty before presenting to Audrey Talley Rostov, MD, Northwest Eye Surgeons, Seattle, "Acanthamoeba keratitis is a sight-threatening infection that can be difficult Washington, with ectasia and scarring. The patient tolerated to diagnose, manage, and treat. It can masquerade as an inflammatory a gas-permeable contact lens but not a scleral lens. Dr Talley process or herpes simplex virus, and secondary infections are common. Rostov discussed a corneal transplant at some future point. In addition, prolonged treatment with multidrug regimens is required. However, 2 months later, the patient experienced trauma Sometimes, even despite appropriate treatment and care, Acanthamoeba and his visual acuity decreased and corneal edema increased, infections can progress and result in severe vision loss and/or phthisis resembling hydrops with diffuse lamellar keratitis. A culture bulbi can occur," Dr Talley Rostov said.
Volume: 1 Issue: 1 IMPROVED DIAGNOSTICS
Intense pulsed light, the brainchild of Rolando Toyos, MD, uses a AND TREATMENTS FOR DRY EYE
xenon flashlamp to provide thermal treatment of MGD by allowing 500 to 800 nanometers of light to pass through a filter.
The MiBo ThermoFlo device (Mibo Medical Group) uses a Until fairly recently, the only therapies used to provide relief thermoelectric heat pump. Preliminary data showed that the from symptoms of ocular surface disease, meibomian gland noninvasive tear breakup time (TBUT) increased by averages of disease (MGD), and dry eye symptoms were various tear 3 and 9 seconds after 1 and 3 treatments, respectively.
formulations and punctal plugs. Things have changed.
The BlephEx handpiece is used in-office to remove the biofilm by "It is good medicine to treat dry eye. We now have new diagnostic debulking the bacterial density using a microsponge along the lid and treatment technologies that lead to happier patients and margin, resulting in significant improvements in the TBUT, clinical better surgical outcomes," stated Marguerite McDonald, MD, severity scale for blepharitis, meibomian gland dysfunction scale, and Clinical Professor of Ophthalmology at New York University ocular symptoms.
Langone Medical Center in New York City and Adjunct Clinical Professor of Ophthalmology at Tulane University Health Prokera Slim (Bio-Tissue), for treating severe dry eye disease, is an Sciences Center in New Orleans, Louisiana. Dr McDonald, amniotic membrane corneal bandage that is applied to 1 eye and who is in private practice at Ophthalmic Consultants of Long then the fellow eye for 5 to 7 days. Prokera Slim Clear has a central Island, Lynbrook, New York, also described some of the more hole to facilitate better vision during treatment.
important potential therapies that are currently available. Dry eye disease also can be assessed using the matrix Most physicians are diagnosing tear film hyperosmolarity, the metalloproteinase-9 test (Rapid Pathogen Screening Inc) and the central pathophysiologic mechanism of all dry eye forms, in Keratograph 5M (Oculus). The Keratograph 5M actually offers 2 minutes with the TearLab Osmolarity System by analyzing a several ways to evaluate the dry eye syndrome/ocular surface patient: 50-microliter tear film sample.
tear film meniscus height calculation; noninvasive, automated TBUT; tear film particle movement to determine tear film viscosity; and the A dry eye diagnostic and treatment, Thermal Pulsation Therapy, R-Scan (Oculus) to document and classify bulbar redness. Tomey introduced by TearScience, includes 2 diagnostic components, also offers a tear stability analysis system.
the LipiView Ocular Surface Interferometer and Meibomian Gland Evaluator, and the treatment component, the LipiFlow The mainstays of treatment that are not to be overlooked include Thermal Pulsation System. This system facilitates lids and masks (Eyegiene Insta-Warmth and Bruder masks are examples), lid meibomian gland treatment in 12 minutes in-office. In a clinical scrubs (OCuSOFT, Avenova, and Systane are examples), omega-3 trial comparison with warm compresses, the meibomian gland fatty acids (TOZAL, PRN, and TheraTears are examples), plugs scores were better in the LipiFlow group (Lane SS, et al. Cornea. (OASIS Medical Form Fit, Eagle, and Parasol are examples), and Lacrisert (Bausch & Lomb). Keep an Eye on your Inbox for More News
from CEDARS/ASPENS in our Summer I∙C∙E

MANY THANKS TO OUR SUPPORTERS
te Collaborate •E
2016 CEDARS/ASPENS

Source: http://www.cedarsaspens.org/download/C-A-Winter-Newsletter-FINAL.pdf