The inaugural Ophthalmology

Transcription

1 60 EW MEETING REPORTER June 2012 Reporting live from the 2012 Ophthalmology Innovation Summit, Chicago ascrs/presentation.html View video from or PowerPoints (pass word OISASCRS) Editors note: This Meeting Reporter contains original reporting by the EyeWorld news team from the 2012 Ophthalmology Innovation Summit, Chicago. Ophthalmology Innovation Summit comes to the ASCRS Annual Meeting OIS spotlights MIGS, cataract surgery The inaugural Ophthalmology Innovation Summit (OIS) at the 2012 ASCRS ASOA Symposium & Congress combined industry, clinicians, and entrepreneurs to discuss the innovation cycle of surgical ophthalmology. The halfday session featured talks on microinvasive glaucoma surgery (MIGS), enhancing refractive outcomes in cataract surgery, a look at the current status and future impact of femtosecond lasers, and where the industry stands on intraoperative aberrometry. Approximately 300 people attended the meeting. Thirty-five percent of those were private company executives, 25% physicians, 15% industry, 10% finance, 10% consultants and other, and 5% media. That s a good mix and speaks to why the meeting is so successful, said Emmett T. Cunningham Jr., M.D., founder and chairman of OIS. It brings together all those constituents who are interested in ophthalmology. William Link, Ph.D., managing director, Versant Ventures, Menlo Park, Calif., and OIS meeting cochair, kicked off OIS with an overview of the innovation cycle. The key constituents, he said, are the inventor/entrepreneur team, the clinician-early adopter, the financial partner, and the industry leaderscommercial team. The innovator/entrepreneur team has amazing problem-solving skills, is not complacent, and makes others around them better. The clinician-early adopter is the openminded medical expert who is constructively critical and judges if the innovation is better medicine and better business. The financial partner brings the money and finds additional expertise and capital as needed. Finally, the industry leaders are the culture that fosters innovation and allows mistakes. They drive adoption and assure access for customers and patients. Dr. Link acknowledged that although the innovation cycle is taking longer than ever and becoming more costly with variable rewards, the ophthalmology industry should not abandon the process. He also gave an overview of the steps in the innovation cycle for ophthalmic technologies. The entire process, which consists of observation and invention, product development, iteration, human proof-ofconcept, CE mark and OUS market development, FDA approval, and U.S. global market development, takes between 10 and 12 years. The strong value drivers of the innovation cycle are the human proof-of-concept, gaining early market access to see where you stand, the FDA approval, and global launch, Dr. Link said. Projects fail at every stage all the way to the end. The principles of innovation, Dr. Link said, are to focus on the big market important issues and find out where the innovation will be rewarded. We always have to direct innovation to where it will be received and rewarded, he said. Making progress is an iterative process. Be open to independent critical input. Don t process information through a tight filter; listen to the feedback you re getting. Dr. Link also stressed discipline, skill, and assertiveness, but to stop short of arrogance. Don t be frozen by the uncertain or the unknown, he advised. Be willing to fail, because you will. When it happens, dust yourself off and move forward. Don t be paralyzed by those mistakes. Learn from them, apologize, and move on. MIGS: Unmet needs and opportunities Ike Ahmed, M.D., glaucoma specialist, University of Toronto, gave a talk on the unmet needs and opportunities in MIGS, pointing out that there s up to three-quarters of a billion dollars invested in glaucoma surgery. Glaucoma is defined as an optic neuropathy with classic visual Ike Ahmed, M.D., presents on unmet needs and opportunties in MIGS Source: Convention Photo by Jeff Orlando

2 June 2012 EW MEETING REPORTER 61 field loss, he said. Elevated pressure is a major risk factor, thought to be due to an increased resistance in the trabecular meshwork, Schlemm s canal apparatus, leading to elevated pressure. The only proven treatment for prevention of visual loss is IOP lowering. The more advanced the disease, the lower the pressure needs to be. The treatment for glaucoma has not changed in the last 40 years, said Dr. Ahmed. Early interventions include pressure-lowering prescription drops followed by surgery such as trabeculectomy, but all of these treatments have significant problems. Glaucoma drops are our mainstay of treatment, he said. We know that over a couple of years of treatment most patients require more than one drop. Most patients are not compliant. Drops are successful they can work but we have issues with compliance, side effects, and costs. Although trabeculectomy is considered the gold standard of glaucoma treatment, it can lead to the dreaded intraoperative choroidal hemorrhage and other complications. Trabeculectomy has significant baggage, Dr. Ahmed said. There are a variety of complications that can occur making it less desirable for us as clinicians and our patients to embark on this road at any stage of the disease. It s the middle-ground glaucoma patients who are lacking treatment options, he said. These are the patients who have mild to moderate glaucoma and are on multiple medications. This is where the need is, Dr. Ahmed said, and this is where MIGS comes in. MIGS is an ab-interno approach, Dr. Ahmed said. It s typically clear corneal, sub-2 mm. There are no typical conjunctival incisions that are made, which is traditional in glaucoma surgery. It s minimally traumatic. It must have at least modest efficacy. I emphasize modest. We re not talking about a dramatic procedure; we have those already. A rapid recovery and ease of use are all important with this procedure. MIGS is not a procedure that will get IOP down to 12. It s typically an earlier intervention and can be combined with phaco. The key to MIGS is to get to patients before their glaucoma becomes advanced. MIGS devices include the istent (Glaukos, Laguna Beach, Calif.), the CyPass Micro-stent (Transcend Medical, Menlo Park, Calif.), and the AqueSys (Irvine, Calif.). Although continued on page 62

3 62 EW MEETING REPORTER June 2012 Reporting live from the 2012 Ophthalmology Innovation Summit, Chicago ascrs/presentation.html View video from or PowerPoints (pass word OISASCRS) Editors note: This Meeting Reporter contains original reporting by the EyeWorld news team from the 2012 Ophthalmology Innovation Summit, Chicago. Ophthalmology continued from page 61 none of the devices are currently approved in the U.S., glaucoma medications will be in jeopardy in the very near future as some of these procedures become available, said Eric Donnenfeld, M.D., Long Island, N.Y. I am very excited about [micro-] invasive glaucoma surgery because I think it has a great future, said Richard L. Lindstrom, M.D., founder, Minnesota Eye Consultants, Minneapolis. During the panel discussion on MIGS, Dr. Donnenfeld gave his thoughts on the impact MIGS would have on ophthalmology as a whole. For the first time glaucoma will go mainstream, he said. Ophthalmologists in general have viewed glaucoma as a subspecialty that s been isolated because the risk-reward ratio for performing glaucoma procedures wasn t something that the average ophthalmologist was comfortable with. Because of that, glaucoma has been isolated into the hands of glaucoma specialists. But the elegance and precision of these new MIGS procedures opens up the realm of glaucoma surgery to the average ophthalmologist, Dr. Donnenfeld said. I think this is going to become the standard of care and may change the way we look at glaucoma. Predicting the future of cataract surgery The second half of OIS@ASCRS focused on enhancing refractive outcomes in cataract surgery. Jack T. Holladay, M.D., clinical professor of ophthalmology, Baylor College of Medicine, Houston, began the session with an overview of the unmet need and size of the opportunity in cataract surgery. In 2007, we did about 3 million cataract surgeries, he said. And in 2011 we did about 3.31 million cataract surgeries. Ten years ago, 72 was the average age of the cataract surgery patient. But because of the improvements in cataract surgery over the last decade, that age has dropped to 66. Bill Link talks about the innovation cycle to a full house Source: Convention Photo by Jeff Orlando The age is becoming younger and the severity of the cataract is becoming less because the success and safety of the operation is so good, he said. Within 5 years, Dr. Holladay expects cataract surgeons to see between a 7% and 16% increase in surgeries. In 10 years, he expects there to be a 20-34% increase in surgical volume. Dr. Holladay pointed out a number of areas that need improving over the next 5 years or so. For example, the brightness acuity tester, which Dr. Holladay invented in 1976, is outdated. We have newer instruments like the one from Visiometrics (Terrassa, Spain) called the OQAS [Optical Quality Analysis System], now the HD Analyzer, that measures light scatter, he said. Wavefront doesn t measure that, visual acuity doesn t measure that, contrast sensitivity doesn t measure that, but light scatter, it turns out, is the one thing that is the most highly correlated with cataract severity and the disability it achieves in a patient. Dr. Holladay believes cataract surgeons in the future will see more devices that objectively measure the disability of the patient as a result of the cataract. He gave an overview of the components of cataract surgery, which he defined as surgical techniques, the IOL calculation hitting the target refraction, and improvements in the IOL itself. He also elaborated on what goes into cataract surgery, which includes making the incision, phaco, IOL insertion, and intraoperative refraction.

4 June 2012 EW MEETING REPORTER 63 With femto-cataract surgery, the cataract surgeon makes a primary incision, a secondary incision to put the second tool in, two arcuate incisions to eliminate the corneal astigmatism, and a capsulorhexis that is absolutely circular, Dr. Holladay said. Finally, the nucleus is softened for easier cataract extraction. Dr. Holladay predicts that within 5 years, all surgeons will be using the femtosecond laser for cataract surgery because of the accuracy (being reported by current users) and patients perception of laser cataract surgery versus the knife. Cataract surgeons are still struggling with toric IOL calculations, which aren t exact, he said. That s because toric IOL calculators use a constant to calculate the toric lens power. But it s not constant. More and more calculators over the next year or two will become exact and give us the exact value for the toricity of an IOL, he said. This is very important because the number of premium IOLs implanted has reached an all-time high of 14.5% of all IOL surgeries. The biggest increase in the premium channel lenses is toric IOLs, and it s because of shared billing, he said. The doctor does not have to bill Medicare for that; he can upcharge the patient and charge for the correction of that astigmatism, and as a result we re seeing premium channel IOLs increasing dramatically. Dr. Holladay concluded with his predictions for cataract surgery in the next 5 years, saying that cataract surgery volume will continue to increase; femtosecond and short-wave lasers will be the predominate technique for surgery; newer IOL calculation formulas, adjustable IOLs, and intraoperative refraction will eliminate astigmatic and some higher order aberrations; and IOLs will accommodate, eliminating presbyopia with either electrical or mechanical means that will automatically adjust the power so there is no loss of contrast/halos or nighttime dysphotopsias. Focusing on premium IOLs Doug Koch, M.D., professor and the Allen, Mosbacher, and Law Chair in Ophthalmology, Cullen Eye Institute, Baylor College of Medicine, discussed the current state and future impact of premium IOLs. The market for presbyopia-correcting IOLs has been flat since Emmett Cunningham, Jr., MD, PhD, MPH Clarus Ventureses In fact, it s only grown 1% from 2005 to Why? Surgeons don t have confidence in the outcomes of multifocals, Dr. Koch said. There s some concerns about the quality of vision and they re not prepared to deal with the patient complaints. There s also the issue of the accommodating IOL unpredictability and an overall lack of confidence in surgical precision, which is required to have these lenses perform well. No one likes to do an IOL exchange, he said. Dr. Koch thinks toric IOLs have cannibalized the premium IOL market because doctors can up- The Ophthalmology l Innovation novation n Summit (OIS) unites leaders in the advancement of ophthalmic products, drugs, and devices. Summit Chairman: Meeting Co-Chairs: Chairs: Advisory Board Members: Anthony P. Adamis, MD VP, Global Head of Ophthalmology Genentech David A. Karcher Executive Director ASCRS O Mark Blumenkranz, MD Professor & Chairman, Department of Ophthalmology Stanford University Michael Kaschke, MD President & CEO Carl Zeiss AG NOVEMBER 8, 2012 Chicago Marriott riott Downtown Magnificent Mile 2011 Attendee Demographics 625 Delegates from 31 States and 17 Countries Represented the Following Categories: Gilbert Kliman, MD Managing Director InterWest s Brook Byers Kleiner Perkins Caufield & Byers Richard Lindstrom, MD Founder & Attending Surgeon Minnesota Eye Consultants William J. Link, PhD Managing Director Versant Ventureses Tom Dunlap President and CEO HOYA Surgical Optics Eugene DeJuan, MD OneFocus Ventures es Professor, UCSF K. Angela Macfarlane ane Sabri Markabi, abi, MD President & CEO Chief Medical Officer ForSight Labs Sr. Vice President R&D Alcon Laboratories, Inc. 4TH ANNUAL AL David Guyer, MD SV Life Sciences Jim Mazzo President Abbott Medical Optics Inc. Senior Vice President Abbott Laboratories atories continued on page 64 Testimonials ials REGISTER TODAY RECEIVE $100 OFF! Use Discount Code: EYEWORLD * Your registration type is contingent upon verification by IBF * *Discount is not combinable with any other promotional offers. * Produced By: David W. Parke II, MD Executive VP, CEO American Academy of Ophthalmology Samir Patel, MD President & CEO OphthoTech Calvin Roberts, MD Executive VP, CMO Bausch and Lomb Ellen Strahlman, MD, MHSc Scott M. Whitcup, MD Sr. VP, Office of the CEO EVP, R&D and CSO GlaxoSmithKline Allergan, Inc. FOR MORE INFORMATION AND TO REGISTER VISIT:

5 64 EW MEETING REPORTER June 2012 Reporting live from the 2012 Ophthalmology Innovation Summit, Chicago Ophthalmology continued from page 63 Roger Steinert, M.D., at the podium with panelists Nick Curtis, LensAR, Leonard Borrmann, Pharm.D., Abbott Medical Optics, Mark J. Forchette, OptiMedica, Dr. Kristian Hohla, Technolas, Ronald M. Kurtz, M.D., LensX Lasers Source: Convention Photo by Jeff Orlando ascrs/presentation.html View video from or PowerPoints (pass word OISASCRS) Editors note: This Meeting Reporter contains original reporting by the EyeWorld news team from the 2012 Ophthalmology Innovation Summit, Chicago. charge the patient with a high likelihood of success, but it s still less expensive for the patient than a multifocal. Relaxing incisions are not widely used, but I think that s going to expand, he said. It s the way people pay for doing femtosecondtechnology cataract surgery. Dr. Koch expects there to be some growth of multifocal IOLs with femto because doctors can perform relaxing incisions and better treat astigmatism. There are two categories of multifocal IOLs: diffractive and refractive. The Oculentis M Plus (Berlin) is a new refractive model IOL that s caught some interest in Europe, Dr. Koch said. I ve heard it s catching on to a certain extent in Europe. Dr. Koch touched on a number of accommodating IOLs currently in development, including Crystalens (Bausch + Lomb, B+L, Rochester, N.Y.), Tetraflex (Lenstec, St. Petersburg, Fla.), Synchrony (Abbott Medical Optics, AMO, Santa Ana, Calif.), AkkoLens (the Netherlands), NuLens (Israel), FluidVision (PowerVision, Belmont, Calif.), and Elenza Sapphire AutoFocal IOL (Roanoke, Va.). Also impacting the future of cataract surgery is intraoperative aberrometry, which Vance Thompson, M.D., assistant professor of ophthalmology, University of South Dakota School of Medicine, Sioux Falls, gave an update on. The measurement of refractive error is very important to both the patient and physician, he said. There are numerous ways to measure refractive error in the clinic, such as with a phoropter, auto-refractor, and wavefront analysis. In surgery, we had nothing, until now, he said. This is why intraoperative aberrometry is such a powerful idea whose time has come. WaveTec (Aliso Viejo, Calif.) and Clarity Medical Systems (Pleasanton, Calif.) are two companies producing intraoperative aberrometry technology with the ORA and Holos, respectively. Intraoperative aberrometry can be used in presbyopia-correcting implants, post-refractive surgery, and astigmatism. Femtosecond lasers: Present and future Roger Steinert, M.D., chairman of ophthalmology, University of California, Irvine, followed up Dr. Holladay s talk with a discussion of the current status and future impact of femtosecond lasers. The femtosecond laser does several things for refractive cataract surgery, he said. We create main and side-port incisions, astigmatic keratotomies which can be either penetrating of the surface or intrastromal anterior capsulotomy, and preparing the nucleus. Possibly down the road none of the systems do this currently is the potential for precise circular posterior capsulotomies that we may need for the new generation of premium IOLs. The femtosecond laser can cut the cornea, as it s been used in more than 3 million corneal incision procedures for LASIK flaps and keratoplasty. The image-guided system is capable of creating patterns that ophthalmologists can t do manually, Dr. Steinert said. With the capsulotomy the question has been: By making it

6 June 2012 EW MEETING REPORTER 65 more repeatable and more perfect in centration, can we improve outcomes? he said. The opening of the capsule should, we think, affect the final resting position of the lens. The manual capsulotomies that we do vary in centration and circularity. As that capsule contracts it shrinkwraps around the implant and can push it around. The laser capsulotomy may give us a more constant effective lens position. The other problem, he said, is an irregular/decentered capsulotomy will contract asymmetrically, inducing coma and astigmatism, as well as other aberrations. Dr. Steinert went over the potential positives and negatives of femto. The potential positives, which he called significant, are better primary incisions, astigmatism control through size and orientation, less risk of endophthalmitis, and better astigmatic incisions that are more reproducible than anything with a human hand. These purely intrastromal incisions have everyone intrigued because they don t violate the surface, there s no risk for infection, he said. They should be more controlled but won t be as powerful; but a lot of the use of this will be for lower level astigmatism, which is really where most of the astigmatism is. Dr. Steinert listed the use of less ultrasound energy (which is better for the endothelium) and less nucleus manipulation as other potential benefits to using the femtosecond laser for cataract surgery. We have here technology that may be the first major change that makes the procedure easier, he said. The most positive impact of this technology may be for the average surgeon. The most glaring negative, Dr. Steinert said, is money. My personal feeling is better technology has historically trumped cost. We find a way to make it work, he said. There s also the time factor, as using the laser increases total time per patient. The specific surgical challenges include patients with small pupils. There will be cases where we can t do the capsulotomy [with the laser], so there s a need to maintain manual skills, he said. My personal conclusion is we certainly know laser refractive cataract surgery will resonate with patients, similar to the all-laser LASIK. Outcomes should improve, but we have to prove that. There are a lot of variables to the systems, Dr. Steinert said, including graphic user interface, imaging technology, patient interface, available incision patterns, and how the nucleus is pre-treated. The current systems on the market are LenSx (Alcon, Fort Worth, Texas), IntraLase (AMO), Victus (B+L/Technolas, Munich), LensAR (Orlando), and Catalys (OptiMedica, Santa Clara, Calif.). The big picture: Innovation in ophthalmology Dr. Lindstrom was next at the podium to give a broad overview of the clinician s perspective on the emerging technologies OIS@ASCRS attendees heard about over the course of the day. In spite of all the rhetoric, healthcare spending keeps growing, he said. We have an aging population and a rising disease burden. Despite the fact that some people believe innovation is going to raise costs, innovation has the best chance at reducing costs. The only reason we can take care of our patients is because of the impact of innovation. Many of these companies are finding that they can outsource innovation more inexpensively than they can do it themselves. Research spending has been growing, he said. We re seeing a transition, especially in ophthalmology, to cash pay, Dr. Lindstrom said. It s not all third-party pay anymore, which is driving a focus toward customer service. The industry is also seeing a collaborative increase between ophthalmologists and opticians, he said. The provider network, which Dr. Lindstrom called the distribution channel of new technology, is strong in the U.S. There are 19,000 ophthalmologists and 38,000 optometrists. We are all doing well, which means we can acquire new technology as it evolves, he said. Dr. Lindstrom called the aging population critical to ophthalmology innovation because a patient over 65 years of age consumes 10 times the amount of eyecare that a patient under 65 does. Key relevant eye diseases for this population include cataract, glaucoma, ocular surface disease, dry eye, allergy, and age-related macular degeneration. Finally, James V. Mazzo, president of AMO, wrapped up the session with a talk on the lessons he learned as president of AdvaMed, the world s largest medical device association. AdvaMed advocates for a legal, regulatory, and economic environment that advances global healthcare by assuring worldwide patient access to the benefits of medical technology ( Annual death rates have declined 16% since 1980, and life expectancy has risen by more than 3 years. Disability rates have dropped by 25%, and a study from the University of Chicago found that improvements in life expectancy from advancements in cardiovascular care alone added 2.6 trillion per year to U.S. wealth between 1970 and We bring devices [to market] that add income, that add jobs, he said. That s the message we have to give to our legislators. It s not that we re adding costs, we re adding results. Mr. Mazzo urged attendees to make sure submissions to the FDA are of the highest quality and pointed out that it s an active time for Medicare. The formation of ACOs [accountable care organizations] is the foundation of the healthcare delivery system, he said. If you don t know about an ACO, I suggest you pay strict attention to how it s going to interact because this is something that carries a lot of momentum as we go forward. The next OIS meeting will be held right before the American Academy of Ophthalmology annual meeting in November. It will be a full-day meeting focused on drugs, drug development, and diagnostics. Visit ophthalmologysummit.com for more information about the agenda as the meeting draws closer. EW Editors note: Dr. Ahmed has financial interests with Glaukos and AqueSys. Dr. Cunningham is the founder of OIS. Dr. Donnenfeld has financial interests with Glaukos. Dr. Holladay has financial interests with Alcon and AMO. Dr. Lindstrom has financial interests with Glaukos, AqueSys, and Transcend Medical. Mr. Mazzo has financial interests with AMO. Dr. Steinert has financial interests with AMO and OptiMedica. Drs. Thompson and Link have no financial interests related to their comments. Contact information Ahmed: Daisy Huerto, on behalf of Dr. Ahmed, [email protected] Cunningham: [email protected] Donnenfeld: [email protected] Holladay: [email protected] Koch: [email protected] Lindstrom: Brenda L. Boff, on behalf of Dr. Lindstrom, [email protected] Link: [email protected] Mazzo: [email protected] Steinert: [email protected] Thompson: [email protected]