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LIVE BLOG RECAP: Ophthalmology Innovation Summit

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Ocular Surgery News attended the Ophthalmology Innovation Summit on Thursday in Chicago. Click to view our live blog of the entire day's presentations.

5:47: Closing remarks.

5:46: Mazzo: "The change is a challenge for our industry."

5:42: According to Mazzo, "We do have some reason for concern -- American device makers are moving overseas, the country of origin provision is a problem, manufacturers are moving overseas, and US FDA approval delays cause increased disruptions."

5:37: Mazzo: "Who's going to be in the Supreme Court in the next 4 years? That's going to make a huge impact on healthcare reform."

5:35: Jim Mazzo, president of Abbott Medical Optics, discusses "The Impact of the Presidential Election on Innovation in the US and Beyond."

5:30: Commentary from Lindstrom to OSN: "Evidence is accumulating that the FDA is transitioning more toward being a part of the solution for constructive medial product innovation rather than the oft perceived obstructionistic bad cop. If so, that will be great for medical product innovation in America."

5:28: Commentary from Lindstrom to OSN: Interesting that only 8% of new drugs that enter FDA trials achieve approval at a current typical cost approaching $1,000,000,000. All agree this is not sustainable. No consensus on a solution , but we need one or really new drugs for major unmet needs will be history.

5:28: Dr. Matthew McMahon, senior advisor for translational research at the National Eye Institute, discusses "Federal Grants to Small Business: How to Get Your Piece of the Pie."

5:15: Sieving: "At the National Eye Institute, we fund about 30% of the applications that we get. ... Our job is to fuel the pipeline in making basic discoveries that turn into company developments."

5:06: Adamis: "In ophthalmology, we need to go after unmet medical needs ... And, more increasingly important, are patients going to pay for this development?"

5:02: Whitcup: "Ten years ago, very small incremental findings were funded. Today, with the reimbursement situation, [the development] really needs to add value for the patients, for the physicians."

4:58: Galakatos: "Without innovation, we wouldn't have productivity. Right now, though, we're in a recession and that cramps our development of new products."

4:55: Pharma Panel 2, "Developing an Ophthalmic Pipeline," commences and is moderated by Dr. Nicholas Galakatos, co-founder and managing director of Clarus Ventures. Panel members Dennis Henner, PhD, managing director at Clarus Ventures; Anthony P. Adamis MD, vice president and global head of ophthalmology for Genentech; Paul Sieving, MD, PhD, director of the National Eye Institute at National Institutes of Health; Scott M. Whitcup, MD, executive vice president, head, R&D and chief scientific officer for Allergan; and, Robert Y. Kim, MD, vice president and head of pharmaceutical product development for Alcon Laboratories.

4:50: Link: "I thhink the lens is continually going to be improved upon, and I think we have a fine start. What we see in Europe is even better."

4:49: Panel agrees on a range of 30-37%. Slade: "32%, but I think we'll get much higher percentages if we offer procedures that are less expensive."

4:48: Corley: "I think the take home message of this discussion is that there's 15 to 20 points available for growth in this market." ... "What percentage of patients will pay something in addition to a normal cataract reimbursement?"

4:47: Barr: "I think we are just scratching the surface. We've already seen the benefits of phaco. Fundamentally, I think if we get better and more consistent outcomes, we'll drive the percentage up."

4:45: Lindstrom: "We still have surgeon training to do. ... Very significant in our practice today are revenues we get in premium procedures."

4:43: Slade: "What's the percentage of people who own a flat screen TV? Wouldn't you pay the same as you would for a flat screen or a dental procedure?"

4:43: Corley: "We have to do a better job of delivering the promise. If we could deliver the promise what percentage of the market would sign up for a premium procedure?"

4:40: Lindstrom: "They need advanced technologies that they can access. If that happens, we'll see the market move about 25% ... I think we can get to 25% or 30% if we help surgeons increase their good outcomes."... "Patients want to get it on the table that day, smiling and happy. Those are the outcomes we need."

4:39: Corley: "What guidance would you have for anybody who wants to make a difference in the premium market?"

4:38: Slade: Most of the surgeons performing cataract surgery are cataract surgeons, not refractive surgeons. Where was ASCRS? Where was AAO in helping make this transition.

4:38: Leoni: Only about 2,500 surgeons are implanting premium lenses in the US.

4:37: Corley: "The industry has spent millions of dollars on consumer advertising. It hasn't worked and it hasn't taken. The ads just don't pay for themselves at the end of the day." Barr: "Because patients are going to trust more of what their physician tells them."

4:35: Slade: Patients don't get multifocal, aspheric any of that. But they get 'laser.' Tying lenses to femto laser, patients will accept.

4:32: Lindstrom: "We surgeons need help from industry to do better. No one would go to get glasses and be happy with a diopter of cylinder and see 20/50. They would never go back to that eye doctor again."

4:30: Barr: "I think doing a better job of picking the right lens for the right patient will lead to better outcomes, which will lead to better patients and better surgeons and higher penetration."

4:24: Corley: "I think the premium IOL market in the US is going to go down in 2013 because it's going to interfere with femto lasers."

4:20: Device Panel 2, "Current Status and Promise of Premium IOLs," commences and is moderated by Andy Corley of Yelroc Consulting. Panel members include John Barr, executive vice president and global president for Bausch & Lomb surgical; Stephen Slade, MD, FACS, surgeon for Slade & Baker Vision Center; Richard L. Lindstrom, MD, founder and attending surgeon at Minnesota Eye Consultants; Seba Leoni, vice president and global franchise head of cataract at Alcon; and, William J. Link, PhD, managing director of Versant Ventures.

3:50: Afternoon break until 4:20.

3:50: Celnik: "You may have to look at other opportunities that exist in the situation that you're in ... Usually, if you've got data and you can explain it, it's worth making the change rather than trying to salvage something because it was the initial investment."

3:49: Guyer asks panelists, "How do you evolved strategies in building a company?"

3:47: Celnik: "If you haven't gotten your footing yet, it's very easy not to trust your intuition. I think that if you're going to take the risk of and have the rewards of being a CEO in a company, you really need to trust your intuition and be willing to address your mistakes."

3:45: Redlick: "There are three headache things that drive me crazy -- when people are not forthright about problems, when CEOs get involved in things that are not in the company's best interest, and people should really be careful with the emails they send. CEOs who are incredibly cool in crisis situations is incredibly important. In merger and acquisition positions, doing it correctly can really be something wonderful for your career."

3:40: Guyer asks, "What's the biggest mistake you've made as a CEO, and what did you learn from it?"

3:38: Patel: "I think having a science background really helps you in a lot of things. This is a science business, so it really helps." Mitchell: "I have a different view. I don't think background really matters ... I think the one thing that is really important is depending on the background of the CEO, what's the casting around that individual? So, if someone comes from a science background, you'd want other people with strong science and medical backgrounds."

3:36: Guyer asks panelists, "How does your background help you as a CEO?"

3:34: Celnik: "Most of your board members are also sitting on a number of other boards and while you're thinking every day about what your business is, their focus isn't always on that. So, it's really important that when you communicate that you frame the conversations well so that they may be productive."

3:32: Mitchell: "There's a big difference between private and public companies, I've found. In a public company, you face a lot of government regulations. In a private company, you don't really have any of that ... What's challenging is having a trade off between this input and doing something about it."

3:29: Mitchell: "As a new CEO, you have the ability to unfreeze the company and start from scratch." Celnik: "I think when you build a team from scratch, you evaluate both the chemistry and functionality of what the company is going to do ... Sometimes there are people in an organization that aren't going to be sustained there. I think it's beneficial for both the company and the employees to make those decisions and make them rapidly so the company can move forward."

3:27: Guyer asked, "How do you start a company from scratch?" Patel answered, "I think it really is about getting people who have the passion .. in a small business, you wear multiple hats, and I think a predefined job description helps a lot. You also have to have the chemistry within workers."

3:22: Pharma Panel 1, "Lessons in Leadership - A CEO Perspective," commences and is moderated by David Guyer, MD, partner for SV Life Sciences Advisers. Panel members include Samir Patel, MD, president and CEO of OphthoTech; Abbie Celniker, CEO of Eleven Biotherapeutics; Dean Mitchell, president and CEO of Lux Biosciences; and David Redlick, partner for WilmerHale.

3:13: Washer: "The sooner the better." Danse: "The focus should be on approval and then delivery."

3:10: Macfarlane asked panelists, "What's the right time to consider delivery in the therapeutic cycle?"

3:09: Erickson: "We've developed a proprietary refill system that allows implant access." The goals of this platform include reducing the frequency of office visits, a lower treatment burden on ophthalmologists, a tunable and customizable system for drug companies and a reduced follow up frequency and reduced cost of care.

3:06: Washer: "We’re talking about something that will affect someone’s entire life. These are very critical needs that are being addressed that, really, no other companies are looking at." The company uses adeno-associated viral vectors in a single injection for wet AMD and rare genetic diseases. The therapy is long-term, potentially lasting for years. It’s also customizable for a wide range of indications.

2:52: Device Panel 1, "Emerging Drug Delivery Technologies," commences and is moderated by K. Angela Macfarlane, president and CEO of ForSight Labs. Panel members include Sue Washer, president and CEO of AGTC; Ted Danse, president and CEO of Neurotech; and, Signe R. Erickson, PhD, vice president of development and clinical application at ForSight VISION4.

2:50: Chambers: Don’t spend a lot of time debating what you think we want but rather ask. Link: We face uncertainty and the agency faces uncertainty…we do error on talking to ourselves, Wiley.

2:45: Eydelman: "FDASIA doesn't introduce any new provisions. Having said that, it does stipulate the time frame when studies need to begin. I don't think it's going to increase the number of post-market studies, its going to force us to look at pre-market versus post-market."

2:38: Chambers: "Is it better to refuse to file the application and send it back to the company until it's ready, or is it better to do a full-review to receive a list of full deficiencies? Which one is going to take the shortest approval time? We still don't have an answer to that."

2:35: Eydelman: "If [physicians] don't understand the reasoning for receiving a deficiency letter, contact us because every reviewer has to go through three levels of management sign-off, so if someone is not clear as to why their device was deficient, there's no reason not to pick up the phone or send an email to ask."

2:35: In regards to FDASIA “least burdensome standard,” Eydelman said she is working on a clarification so the Review Staff and the “folks outside” have a standard definition. “So this is still a work in progress,” Lindstrom said.

2:30: Eydelman said she was “delighted” to announce the reorganization of her division. The Division of Ophthalmic, Neurological and Ear Nose and Throat Devices (DONED) has been split. It is now the Division of Ophthalmic and Ear Nose and Throat Devices (DOED) and Division of Neurological Devices (DND). The DOED now has 40 reviewers, 8 managers (7 from DONED). “As you can imagine I am very excited about this,” she said.

2:27: According to FDASIA, "FDASIA clarifies that the FDA can mandate only the 'minimum required' clinical information to support approval or clearance. This provision appears intended, in part, to constrain reviewers from requesting data not directly relevant to the approval process." Panelists are answering the question, "How might this standard impact the regulatory process?"

2:24: In giving advice to physicians on meeting with the FDA, Chambers said, "I'm never going to turn a meeting down. With that said, for the ID process we usually find it more beneficial to submit an ID, get an answer from the FDA about what is potentially missing and then ask for a meeting. I think getting the process going really minimizes any delays."

2:18: Peterson: "The truth of the matter is that every time we've had meetings with the FDA, they've been interactive and good. We've walked away feeling good. The only issue we've had is with the timelines to meet back together ... At least from AcuFocus' standpoint, our relationship with the FDA in the meetings has been helpful and directive and has worked well. The timing to get back together face to face has been the only problem."

2:13: Eydelman: The total number of submissions received by the FDA's Division of Ophthalmic, Neurologic and Ear, Nose and Throat devices (DONED) in 2011 was 1,385. In 2012, 1,441 submissions were received.

2:12: Panelists include Wiley Chambers, MD, supervisory medical officer at the Division of Transplant and Ophthalmology Products; Malvina B. Eydelman, MD, director of the Division of Ophthalmic, Neurologic and Ear, Nose and Throat devices; William Link, PhD, managing director at Versant Ventures; Ed Peterson, president and CEO of AcuFocus; and, Quinton Oswald, CEO of SARcode Bioscience.

2:07: Richard L. Lindstrom, MD, founder and attending surgeon at Minnesota Eye Institute, moderates a panel on the "Impact of Funding and the Innovation Act on the FDA."

2:06 Sternberg: "Our presentation to this group is a critical step. We continue to vet the concept with our partner, the FDA. We are actively gaining interest from the industry in supporting this project."

2:03: Paul Sternberg, Jr., MD, G.W. Hale Professor and Chairman at Vanderbilt Eye Institute, discusses "Pilot Project on Ophthalmic Device Research Centers of Innovation."

Commentary from Richard L. Lindstrom, MD, to OSN:

• "Both Alcon and Allergan leadership confirm that there are significant unmet needs in ophthalmology. This represents opportunity. The bad news...regulatory barriers are high and third party payers are less and less inclined to pay for innovation. The solution -- More patient responsibility for the costs of new and innovative products and treatments. This is a global trend.

 12:30 to 2: OIS luncheon with award ceremony and keynote. 2012 OIS Award Recipient Scott M. Whitcup, MD, executive vice president, R&D and Chief Scientific Officer for Allergan, will deliver his acceptance speech, "Innovation in Ophthalmology: Beauty is in the eye of the Shareholder" from 1 to 1:10. Kevin Buehler, division head for Alcon, will deliver the Plenary Keynote Lecture from 1:10 to 1:40. Presentations will continue at 2.

 12:28: As a medical device indicator, ophthalmology has taken an average of 5.4 years to exit from 2005 to 2012, according to Norris.

12:22: According to Norris, older companies represent the most significant risk of broken investor syndicates, non support from insiders and a potential shut down. "Even if these companies are unable to raise additional equity, that still leaves potential investment opportunities for investors with fresh capital to deploy."

12:19: Jon Norris, managing director at SVB Capital, discusses "Private Funding and Exit Trends."

12:16: According to Gibney, the predictability of regulatory companies has increased, eye care stocks have maintained or increased within the last year and many ophthalmic advances have developed within the last year. Novartis, Allergan, Roche, Santen, Pfizer, Merck and Regeneron are the leading ophthalmology players, each donating more than $10 billion to ophthalmology research since 2011. Gibney also noted that only 2% of total ophthalmology sales is branded sales because ophthalmology is highly genericization.

12:10: Anthony Gibney, managing director of Leerink Swann, discusses "The Ophthalmology Market - A View from the Public Sector."

12:01 p.m.: Noel Alpins, MD, FACS, CEO of ASSORT, discusses the ASSORT software products. "These innovative software products fill the need in the ophthalmic industry for a computerized surgical management system that would complement electronic medical records, office management and billing systems. These clinically useful software products also offer increased sophistication to computer driven laser techniques in femtosecond cataract and LASIK surgeries."

11:53: Mark S. Blumenkranz, MD, founder of DigiSight, discusses the smartphone application SightBook, which "enables patients to monitor their vision while away from the doctor's office and transmits test data securely and in real time to their designated physicians, enabling doctors to deliver personalized treatment for chronic disease efficiently and effectively."

11:45: Greg Rakas, Midwest sales manager of ZocDoc, discusses the advantages of ZocDoc, a "free way to find a doctor and book an appointment instantly online." The service is currently offered in 31 major cities across the United States and is also available in Spanish.

ZocDoc commentary from Richard L. Lindstrom, MD, to OSN: