OIS@ASCRS

APRIL 24, 2014 | BOSTON, MA

EXECUTIVE REPORT

2014

WITH AN EYE ON

INNOVATION

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2014 Executive Report By: Larry Haimovitch & Michael Lachman BOSTON — The Third Annual Ophthalmology Innovation Summit (OIS@ASCRS) took place on April 24, just prior to the 2014 annual meeting of the American Society of Cataract and Refractive Surgery (ASCRS). The purpose of this conference is to support innovation by facilitating deal-flow and business partnerships between CEOs of young companies, investors, corporate executives, physicians and academic scientists in the field of ophthalmology. A newly expanded agenda format, which more closely resembled the flagship OIS@AAO meeting, was met with rave reviews in Boston.

The program included a total of 17 innovative companies that are treating conditions in either the anterior and posterior chambers of the eye. First time OIS presenters were EyeSonix, Anew Optics, RPS- Rapid Pathogen Screening, pSivida, CXLO, TearLab, Tear Science, and Panoptes Pharma while the returnees included ClarVista Medical, PowerVision, i-Optics, WaveTec Vision Systems, Clarity Medical Systems, Avedro, Mimetogen Pharmaceuticals, Eleven Biotherapeutics, and Ocular Therapeutix.

Private Ophthalmic Device Companies Showcase

Jeroen Cammeraat CEO i-Optics

The device segment was kicked off by Jeroen Cammeraat, CEO of i-Optics, whose private Dutch company offers eye diagnostics that it touts as “affordable, fast and user friendly.”

Its product line includes the Cassini, a corneal shape analyzer, which Cammeraat said provides “the true axis and magnitude” of astigmatism and thus is highly valuable for premium IOL planning. The color coded device is highly accurate due to its color LED triangulation technology. An article in the April 2014 issue of Cataract & Refractive Surgery Today concluded that the device “demonstrated high specificity in measuring corneal astigmatism.” Several highly regarded cataract/refractive surgeons have already adopted the technology.

EyeSonix’s President & CEO, Donald Schwartz, MD, a practicing comprehensive ophthalmologist, discussed an “entirely new” technology to treat open-angle glaucoma.

The company’s patented Therapeutic Ultrasound for Glaucoma (TUG) device generates heat in the range of 40° to 45° Celsius in the ultrasound probe to create a cascade of cytokines. These cytokines are a potential mechanism for the reduction of intraocular pressure (IOP). Schwartz discussed his limited clinical data (70 patients treated to date), which shows excellent safety and meaningful IOP reduction in most patients.

Donald Schwartz, MD President & CEO EyeSonix

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EXECUTIVE REPORT

Anna Hayes, CEO of Anew Optics, presented the company’s Zephyr, a two ring intraocular lens (IOL), which is designed to keep the capsule open and hence minimize fibrosis. The 18% hydrophilic acrylic IOL, which is inserted using a standard 3mm incision, has shown very promising results in both a rabbit and cadaver. The company hopes to begin a first-in-man clinical trial in Europe this year and in Canada and Mexico next year.

FRONT VIEW

SIDE VIEW

Another interesting IOL technology was presented by ClarVista Medical’s President & CEO Paul McLean, who introduced the Harmoni Modular IOL system. He described the lens as a two-piece device, which is implanted with a two-step injection through a typical incision and then assembled in the bag. It can be manufactured in a mono-focal, atoric or multi-focal design. According to McLean, the base component is an elegant positioning device for the optic component which is easy to exchange and optimize with a post-operative exchange.

The company has already initiated its human trials, with a multi-center randomized trial underway. A total of 30 patients have been implanted to date with excellent safety and efficacy seen in all patients. The company is hoping to raise more funds to attain CE mark and begin its U.S. IDE trial.

A past presenter at OIS meetings, President & CEO Barry Cheskin of PowerVision, provided an excellent update on his company’s FluidVision accommodating IOL. Cheskin reiterated what he has said several times before at OIS meetings, “The FluidVision IOL is the only technology that provides true accommodation.” It maintains the natural mechanism of accommodation via a shape change in the IOL, powered by the natural ciliary muscle forces. The FluidVision IOL is paired with a novel pre-loaded PowerJect injector, making the IOL delivery easy and simple.

Cheskin reported that an early feasibility trial has enrolled a total of 33 patients, showing injectability, excellent distance, near visual acuity, and desired accommodation with at least 2.5 diopters for every patient. The company is now in the midst of a multi-center, sighted eye trial in Europe, with the goal of attaining CE mark with this data. It hopes to begin its U.S. trial sometime in 2015.

Keith Mullowney CEO Clarity Medical Systems

Clarity Medical Systems CEO, Keith Mullowney provided an update on his company’s progress, notably the HOLOS IntraOp, their wavefront aberrometry system. Commercial shipments of this product, which is touted as a real-time guidance device to assist cataract surgeons in IOL selection intraoperatively, are slated to begin in the second half of 2014.

EXECUTIVE REPORT

Holos will compete against ORA Holos will compete against ORA, a system sold by WaveTec Vision Systems, whose President & CEO, Tom Frinzi, also presented. Frinzi, who has been a key player in driving market acceptance of intraoperative aberrometry, noted that “WaveTec Vision Systems is perfectly positioned for 21st century medicine.” This opinion was predicated on the fact that his company’s technology is: (1) Patient-centered (focuses on the patient, ensures the highest quality care); (2) Consumerdriven (empowering people, decisions driven by consumers, not third party providers); and (3) Provider-friendly (enables the highest level of care). This paradigm of the new world of health care was discussed in a recent article in the New England Journal of Medicine.

Frinzi contended that his company’s ORA technology meets all three criteria for success in 21st century health care. It provides “optimal outcomes” to patients with both IOL implants and limbal relaxing incisions, while reducing the rate of costly re-treatments by 50%.

ORA is also provider-friendly, generating a 41% increase in premium IOL conversions and boosting the surgeon’s annual revenue by an average of $186K. He concluded by saying that the ORA, enhanced with VerifEye technology, is a “must have” for all cataract and refractive surgeons.

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Later in the day, industry executives from the three leading players in ophthalmic surgery expressed enthusiasm for intraoperative aberrometry. Calvin W. Roberts, MD, Executuve Vice President & Chief Medical Officer for Bausch + Lomb (Valeant Pharmaceuticals), commented, “I really think that’s the way to go for cataract surgery.

“So, for us at Bausch + Lomb, it’s not a question of ‘if’, it’s really just a question of ‘when’. We’re just looking for the right opportunity to make intraoperative aberrometry a part of our surgical suite.”

Laurent Attias, Head of Global Commercial Strategy at Alcon (Novartis), added that surgeon adoption of premium IOLs is linked to clinical confidence in achieving excellent refractive outcomes, and intraoperative aberrometry and pre-op diagnostic tools all contribute to this result. “So all of these technologies are of great interest to us. The best guidance will lead to the highest clinical confidence, and therefore the greater comfort in adoption.”

Laurent Attias Head of Global Commercial Strategy Alcon

Private Ophthalmic Device Companies Showcase Paul Ashton, President & CEO of pSivida, a publicly traded company (NASDAQ symbol PSVD), provided an update on his company’s sustained release drug delivery technology. Its long-term sustained bio-erodible system, trade named Tethadur, is showing great promise for delivery of anti-VEGF drugs to treat macular degeneration and diabetic macular edema. The drugs currently available for these ophthalmic conditions require about seven injections annually, which is inconvenient for patients and their caregivers.

The company’s technology is “sticky” to proteins and is nanostructured to fit the targeted protein. Early data from a study of Avastin, widely used for wet AMD, is showing that it provides greater than 4-month release and achieves levels well above therapeutic concentration in vitro.

Confirmatory in vivo studies are ongoing.

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Another returning presenter was Amar Sawhney, PhD, President & CEO of Ocular Therapeutix. His company’s vision is “to transform the treatment of eye diseases by creating sustained therapies with our hydrogel technology.” The company received its first FDA approval in January 2014, when its ReSure Sealant was approved. ReSure is a first of its kind sealant for wound closure, intended as a replacement for sutures. The company recently began to commercialize the product.

The company’s future projects include: (1) Posterior segment sustained release injections, with the first project being a sixmonth sustained release anti-VEGF for retinal diseases; and (2) Anterior segment punctum plug therapies, with three projects underway (single-dose steroid for complete post-op inflammation course, 2+ months sustained release PGA for treatment of glaucoma, and a single-dose antibiotic for the complete treatment of conjunctivitis).

Amar Sawhney, PhD President & CEO Ocular Therapeutix

The last presenter of the morning was Franz Obermayr, CEO of Austria-based Panoptes Pharma. This privatelyheld biotech company is developing a product called PP-001 for the local treatment of non-infectious uveitis.

This condition, a serious inflammation of the uvea of the eye, is a major cause of blindness. Early clinical data, in vivo in animal models, is promising, with a 50% reduction in the number of relapses. The company plans to begin its first human trials by 2015.

Review of the Ophthalmology Innovation Cycle The topic of failed companies is rarely discussed in open forums, but often provides very valuable information. In a presentation titled, “Sometimes things don’t go as planned -- Where in the innovation cycle did it go wrong?”

OIS Chairman, Bill Link, PhD, Managing Director of Versant Ventures, set the stage for three case studies with an outline of key risk factors:

Key Risks – Ophthalmic Surgical Innovation • • • • •

Technology/Science - Can it be built?

Clinical Performance - Does it work? Is it safe?

Regulatory Path - Can we get it on the market?

Reimbursement - Will it be paid for?

Commercialization/Competition - Can it win in the marketplace?

Pictured from L-R: Sabri Markabi, MD, Chief Medical Officer & Senior Vice President R&D - Alcon, Jim Mazzo, Operating Partner - Versant Ventures, Angela McFarlane, President & CEO - ForSight Labs, Thomas Frinzi, President & CEO - WaveTec Vison Systems, Bill Link, PhD, Managing Director - Versant Ventures

Tom Frinzi, the former CEO of Refratec, reflected on the failure of this company. He reviewed the financing history, regulatory approvals and the commercial impact of the company. The procedure, which was called Conductive Keratoplasty (CK), involved heating the cornea with RF energy to alter its curvature and correct vision. In 2004, Refractec registered about $15 million in revenue and seemed to be on a roll. However, CK treatment lacked durability, eventually causing sales to plummet and leading to its demise.

EXECUTIVE REPORT patients. Despite these solid results, it was not successful in reducing early post-op pain for PRK and the product struggled to gain market acceptance. NexisVision has since diversified its activities, developing a “novel” contact lens technology, which was recently licensed to one of the major contact lens companies.

Bill Link talked about the demise of NeoVista, another venture-backed company that failed in its mission.

Formed in 2002, NeoVista targeted the treatment of wet macular Tom Frinzi degeneration, using strontium President & CEO 90 beta radiation. Whereas its WaveTec Vision Systems earlier feasibility trials had shown tremendous promise, its 495 patient pivotal trial called CABERNET failed for an unusual reason—the control Frinzi described the technology arm, which was well-received by as a “revolution in need of an Lucentis, outperformed all prior evolution” and speculated that with results. Though the patients treated the availability and use of corneal with radiation enjoyed improved cross-linking, this technology results, the pivotal trial missed its could become more durable and non-inferiority primary endpoint potentially have a resurgence, and, as Link said, in early 2013 again gaining market traction. “we folded the tent.” Approximately $97 million had been invested in Dr. Marguerite McDonald, a this venture, representing one of renowned cataract and refractive the biggest losses in recent years surgeon, discussed the travails of for medtech venture investors.

NexisVision, a company formed in 2008 to target the next generation The failed company presentations of corneal refractive surgery (LASIK transitioned into a panel discussion comfort and function without a where several industry participants flap). Its first product, the Nexis weighed-in with their views on Shield, was intended to provide a what causes or contributes to smooth and stable optical surface failed ventures and when it is time and to restore corneal physiology to shutdown a business. Sabri by minimizing edema and light Markabi,MD, Chief Medical Officer scatter for PRK patients. and Senior VP R&D of Alcon, asked, “is there enough clinical evidence or The concept worked, the technology differentiation’” to continue funding provided faster edema resolution and take the product further down and epithelial healing, and most the road? Jim Mazzo, Operating importantly, improved uncorrected Partner for Versant Ventures and visual acuity for both LASIK and PRK

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former head of AMO, focused on people issues by asking, “Do you have enough guts to admit failure and move on?” adding that it is best to “fail and fail fast” if the company is struggling.

Angela MacFarlane, President and CEO of ForSight Labs, noted that sometimes the passion to start a business blinds an entrepreneur to failure. She stated that “a contrary point of view is critical” to the decision to move forward or quit the business.

Bill Link said that an accurate and brutally honest assessment of the competition is critical. In the case of NeoVista, “It was hard to admit that the Lucentis data was credible and as good as it appeared.”

Bill Link, PhD Managing Director Versant Ventures

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EXECUTIVE REPORT

Ophthalmology Innovator Award This year’s Ophthalmology Innovator Award was presented to Mark Forchette, who served as President and CEO of OptiMedica for six years until the company’s acquisition by Abbott Medical Optics (AMO) last year.

Under Forchette’s leadership, OptiMedica established itself as a technology leader in the emerging field of femtosecond laser cataract surgery. The presentation was made by OIS co-chair Gil Kliman, MD, Managing Director of Interwest Partners, who also interviewed the award recipient. Forchette described a pivotal moment in his life that occurred during his late teens, when he had the opportunity to speak one-on-one with Ray Kroc, the legendary founder of McDonald’s. This encounter ignited his interest in business and entrepreneurship, and the possibility of someday becoming a CEO. Forchette entered the ophthalmic field 30 years ago when he joined Swiss vitreoretinal instrument manufacturer Grieshaber & Co., eventually leading the company’s U.S. operations. After Grieshaber was acquired by Alcon in 1998, he stayed on and led Alcon’s global vitreoretinal business. Forchette said that it was a difficult decision to leave a market leader like Alcon, but he was attracted by the quality of the people involved with OptiMedica.

“Success in business boils down to two things: you have to have technology that resonates and really delivers, and you’ve got to have passionate people that are committed to it. I saw both of those things at OptiMedica.”

Mark Forchette Former CEO - OptiMedica

Forchette recounted a particularly challenging period during the company’s product development stage, when incomplete capsulotomies were noted in some cataract patients treated with the laser. Consistent with OptiMedica’s “patients first” value system and philosophy that “a well defined problem is nearly solved,” the company halted its clinical trial, determined the cause of the problem, and developed a solution. The result was the novel and differentiated LiquidOptics patient interface. Regarding the outlook for femtosecond laser technology, Forchette sees great promise. “You put a great device in the hands of talented, forward-thinking physicians, and there’s no telling how far you can take it. I think there’s a very robust future ahead.”

The Role of OUS Clinical Studies in Ophthalmic Innovation Malvina B. Eydelman, MD, Director of the FDA’s Division of Ophthalmic Device Evaluation noted that a recent review of 10,000 clinical studies showed a marked shift toward OUS sites, with less than 40% of studies currently conducted in U.S. sites, down from about 55% in 2007. Initial clinical testing of some novel devices has also moved to non-U.S. sites, and some devices are being developed exclusively for non-U.S. markets. A major potential consequence of this trend toward more OUS clinical studies is longer total time to gain FDA approval for new products, due to a lack of prior U.S. experience and concerns regarding the applicability of study findings to the U.S. population and U.S. clinical practices. Although U.S. approval can be based solely on OUS data, the FDA encourages companies to include at least some U.S. sites in their clinical trials.

EXECUTIVE REPORT

“We have chosen to concentrate on FDA’s opportunities to bring clinical trials back to the U.S.” Malvina B. Eydelman, MD

Director, Division of Ophthalmic Device Evaluation - FDA

“We have chosen to concentrate on FDA’s opportunities to bring clinical trials back to the U.S.” said Eydelman, and the FDA has identified a number of actions it can take in this regard. These include bringing greater predictability and consistency to its decision-making process for clinical trial submissions (IDEs), increasing speed and efficiency with these decisions, rebalancing risk/benefit requirements, and improving transparency of communications. “In the next two years, we will focus on reducing the time and number of cycles needed to reach full IDE approval, and increase the number of early feasibility and first in human studies conducted in the U.S.”

increased the percentage of IDEs fully approved in the first review cycle from 4% to 22%, and reduced the median overall time to full IDE approval from 435 days to 174 days. In order to facilitate U.S.-based clinical development of novel products, the FDA’s Ophthalmic Devices Division is developing “Leap Frog Guidance” documents, in which the agency can share its initial thoughts regarding the content of premarket submissions for emerging technologies. The first such guidance document was issued in March 2013, covering retinal prostheses. Guidance documents are under development for minimally invasive glaucoma (MIGS) devices and premium IOLs. The FDA has also conducted a number of workshops and symposia Eydelman said that the agency has made progress covering clinical trial design and endpoints for specific on multiple fronts, and claimed that improvements types of devices. implemented by the FDA between 2011 and 2013

Pictured from L-R: Donald Tan, MD, Director - Singapore National Eye Centre, Aron Shapiro, Vice President – Ora, Matteo Piovella, MD, Director - Centro di Microchirurgia Ambulatoriale (Italy), Malvina Eydelman, Director Division of Ophthalmic Device Evaluation – FDA, Roberto Zaldivar, MD, President - Instituto Zaldivar S.A. (Argentina ), Michael Mrochen, PhD, Founder & CEO - IROC Science to Innovation (Switzerland)

Although the regulatory approval hurdles for medical devices in Europe have always been substantially lower than in the U.S., changes currently underway in Europe “are going to be quite substantial,” according to Michael Mrochen, PhD, Founder and CEO of Swiss ophthalmic research organization IROC Science to Innovation. While CE mark approval has always been based more heavily on technical product characteristics than on clinical data, Mrochen noted that there will be increasing focus on clinical data, including post-market surveillance studies, and allowed for the possibility that there could be some near-term “overshoot” with respect to this shift in policy. Matteo Piovella, MD, an ophthalmic surgeon based in Monza, Italy, pointed out that European regulators are looking to the FDA as an example to update and harmonize their systems, “but they don’t want to do the same as the FDA, this is for sure.”

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According to the panelists, some of the benefits of obtaining OUS clinical data during the development process include the ability to treat a large number of patients at a lower cost than in the U.S., to incorporate racial diversity, and to obtain in-country clinical data to support eventual OUS commercialization.

Drug-device combination products pose particular regulatory challenges, according to several of the panelists. Mrochen, who was involved with the early development of corneal collagen cross-linking using riboflavin and UV light, noted that riboflavin is approved as a medical device in Europe and many other regions. It is considered a drug-device combination in the U.S. and some Asian countries, and in China they actually don’t know what to do with it. Eydelman of the FDA advised that companies with such combination products obtain country-specific regulatory guidance very early in the development process.

In closing the session, Piovella expressed the view that “the dream and the reality” should be unified, global regulatory approvals rather than the current country-by-country system. In this regard, Eydelman pointed to the work of the International Medical Device Regulators Forum (IMDRF), which is a voluntary group of medical device regulators from the U.S., Europe, and six other countries that aim to accelerate international regulatory harmonization and convergence.

Dry Eye - Challenges and Opportunities “Historically, the only clinicians that were interested in dry eye were the cornea specialists; the rest of ophthalmology discarded it and thought these patients were somewhat of a burden,” noted Edward J. Holland, MD, of the Cincinnati Eye Institute, in his dry eye disease (DED) market overview. However, cataract and refractive surgeons, as well as their glaucoma and retina colleagues, have come to recognize the ocular surface as a major factor in patient outcomes. “It seems like everybody in ophthalmology is now interested in dry eye.”

“We also understand that dry eye is incredibly under-diagnosed,” said Holland. Estimates of dry eye prevalence vary widely, from as low as 8% to as high as 48% depending upon how the disease is defined. Of the estimated 55 million Americans with DED, it is estimated that as many as 39 million may not have been diagnosed.

Edward J. Holland, MD Dir. of Cornea Services, Prof. of Ophthalmology Cincinnati Eye Institute

New point-of-care diagnostic tests could improve the rate of dry eye diagnosis, and two companies that are marketing such products presented at OIS. Publicly-traded TearLab Corporation (NASDAQ symbol TEAR) markets the TearLab Osmolarity System, the first-ever nanofluidic diagnostic platform. High tear osmolarity causes inflammation, and osmolarity is a biological marker that correlates to DED severity. Using just 50nL of a patient’s tears, the test quantifiably measures the severity of DED, and is objective and sensitive enough to be used for both diagnosis and disease management. The point-of-care test is CLIA waived, Medicare reimbursed at $45 per patient, and covered by more than 90% of private insurance plans in the U.S. TearLab has placed, at no cost, approximately 2,500 test systems in more than 1,100 practices in the U.S., and sells disposable test cards for $20-25 per patient.

EXECUTIVE REPORT Rapid Pathogen Screening, Inc. (RPS) develops and markets point-of-care diagnostic tests for infectious and inflammatory diseases. The company’s InflammaDry test detects elevated levels of MMP-9 in tears for diagnosis of DED. MMPs are proteolytic enzymes that are produced by stressed epithelial cells on the ocular surface. Although MMP-9 is a non-specific marker for DED, it becomes very specific when combined with a slit lamp exam, and is synergistic with other diagnostic tests. InflammaDry can help guide treatment, because patients that are positive for MMP-9 are more likely to respond to anti-inflammatory therapeutics, such as Restasis. The test received both a CLIA waiver and Medicare reimbursement earlier this year.

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dry eye patients and 86% of patients with a classified subtype have signs of evaporative dry eye resulting from meibomian gland dysfunction (MGD).

TearScience, which has raised $150 million since its founding in 2005, is the only company with FDA clearance to treat evaporative dry eye, or MGD. New clinical data previewed at OIS shows that after one year, one 12-minute LipiFlow treatment resulted in a 3x increase in gland function in 90% of patients, and 50%+ reduction in symptoms for 80% of patients.

The in-office treatment system was launched in 2012, using a patient self-pay business model. TearScience currently has 265 customers that have delivered about 40,000 treatments. The company is positioning itself Regarding these new point-of-care tests, Eric in the premium vision care segment by addressing Donnenfeld, MD, Immediate Past President of unstable tear film issues related to premium refractive ASCRS, commented, “Diagnosis is going to really implants, contact lens intolerance and LASIK-induced facilitate better management of dry eye, and as this dry eye. becomes more widespread, I think that the average ophthalmologist will embrace these tests in a very On the dry eye biopharmaceutical front, the panel significant way.” Refractive surgeon Vance Thompson, discussion highlighted the difficulty in obtaining FDA MD added that these two tests “have already become approval for new therapeutics. Restasis from Allergan, foundational in our dry eye program. Even though it’s which was approved in 2003 and will likely reach $1 starting with specialists, the tests are becoming so good billion in annual sales this year, is the only FDA approved that it will filter down into general ophthalmology and pharmaceutical treatment for dry eye. Holland showed optometry.” a list of seven compounds that have failed to meet efficacy endpoints in recent FDA trials, and noted, “We For years, it was believed that aqueous deficiency need to figure out a pathway for approval. A lot of was the most prevalent subtype of dry eye, but recent clinicians know that in these trials the compound was findings suggest that only about 10% of patients show effective, but the way the FDA trials are set up, we just pure aqueous deficiency. In contrast, about 60% of all couldn’t prove efficacy.”

“With the FDA, you need to have a sign and a symptom that are positive. Very bluntly, signs and symptoms in dry eye disease do not correlate. It’s basic science. We need to have a better pathway for allowing some of these very valuable drugs to be approved, and the one we have right now is just not working.”

Eric Donnenfeld, MD Immediate Past President - ASCRS

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Two companies presented their dry eye therapeutic technologies at OIS. Mimetogen Pharmaceuticals is developing TrkA agonists for dry eye disease, led by the late-stage program MIM-D3, a first-in-class smallmolecule compound. TrkA agonists have the potential to break the dry eye disease cycle by increasing tear mucin levels, reducing ocular surface damage, improving corneal sensitivity, and improving the overall lacrimal functional unit.

Eleven Biotherapeutics is focused exclusively on the development of protein therapeutics for ophthalmic diseases, based on the proprietary AMP-Rx platform.

The company’s lead product, EBI-005, is a topical IL-1 antagonist in Phase 3 development for DED, targeting a BLA in 2016. IL-1 regulates inflammatory response to ocular surface stress, and IL-1 receptors are also present on the neurons of the eye. As such, blocking IL-1 receptors can reduce both ocular surface damage and ocular pain, thereby addressing both signs and A 150-patient Phase 2 study showed consistent symptoms of DED. In the Phase 2 study, EBI-005 improvement across multiple signs and symptoms of was also shown to affect patient behavior, as treated DED and results from a pivotal 400-patient Phase 3 patients used less than half of the amount of artificial study will be available by mid-2014. tears as the vehicle control group.

Later in the day, the Industry Perspectives panel took up the question of corporate interest in devices and diagnostics for dry eye. Jane E. Rady, Divisional VP of Business Development with Abbott Medical Optics (AMO), said that the large economic burden and unmet clinical need make dry eye a compelling market opportunity, although the high regulatory approval hurdles represent a major concern. She characterized the work being done to validate new clinical markers and endpoints as “highly interesting.”

Executives from Alcon, AMO, and Bausch + Lomb all agreed that diagnostic products, including those targeting dry eye, make good business sense for their companies only if they can guide the use of a more lucrative therapeutic product that is also part of the portfolio. “Until there’s a drug that effectively treats dry eye, it’s very difficult to have anything that sits behind it,” said Quinton Oswald, President & CEO of Neurotech. “Start with the therapeutic, and the diagnostic will follow.”

“Until there’s a drug that effectively treats dry eye, it’s very difficult to have anything that sits behind it.”

Quinton Oswald President & CEO - Neurotech

EXECUTIVE REPORT

Corneal Cross-Linking - An Emerging Field

Pictured from L-R: Roy Rubinfeld, MD, CEO - CXLO, Stephen Slade MD, Surgeon - Slade & Baker Vision Center, Anthony Natale, MD, Venture Partner - Aperture Venture Partners, William Trattler, MD, Director of Cornea - Center for Excellence In Eye Care, A. John Kanellopoulos, MD, Director - LaserVision.GR Institute, Maureen O’Connell, President - O’Connell Regulatory Consultants, George Waring IV, MD, Medical Director - Magill Vision Center, David Muller, PhD, President & CEO - Avedro

Energizing the afternoon programming was a lively point-counterpoint session featuring two companies, Avedro and CXL Ophthalmics. As previously announced in mid-March, the FDA requested more information from Avedro regarding its NDA submission, effectively delaying entry into the U.S. market by a year or possibly more. Several participants in this session expressed clear disappointment and frustration about this seemingly inexplicable decision made by the FDA. For example, Maureen O’Connell, a regulatory consultant, said, “This {delay} is frustrating for all of us.” She added that cross-linking has been available throughout Europe for the past eight years. John Kanellopoulos, MD, a refractive surgeon from Greece who also practices in New York, said that 35% of his European practice in the past ten years has involved the use of corneal cross-linking and added that “I am very sad that cross-linking is not approved in the U.S.” The physicians and panelists agreed that cross-linking is a valuable technology and its eventual approval in the U.S. will be extremely well-received. For example, George Waring IV, MD said, “cross linking is game changing technology.” Stephen Slade, MD said that it will be a very important technology to treat keratoconus, the most common corneal dystrophy in the U.S. and the second leading cause of blindness worldwide.

Although cross-linking was initially developed as a therapeutic procedure to treat keratoconus and post-LASIK ectasia, its applicability is far broader. Avedro’s President & CEO David Muller, PhD pointed out that his company is targeting several elective (refractive) procedures that could dramatically grow the cross-linking market. These include LASIK XTRA and photorefractive intrastromal cross-linking (PIXL). The former, which has been commercialized in 35 countries, is aimed at improving LASIK outcomes while the latter, which will be launched later this year, targets myopia and post-cataract astigmatism.

George Waring IV, MD Medical Director Magill Vision Center

“Cross Linking is Game Changing Technology.”

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EXECUTIVE REPORT

Avedro has placed over 400 systems worldwide and has developed a business model, with a significant portion of its revenue generated by very high margin disposables.

CXL Ophthalmics CEO, Roy Rubinfield, MD discussed his company’s approach to corneal cross-linking, strongly extolling the virtues of delivering the riboflavin with the epithelial tissue remaining on. This approach is called “epi-on.” Rubinfield said that this technique is safer and more effective than the traditional “epioff” procedure, fostering more rapid recovery and enabling the patient to return to normal vision sooner. He closed by saying, “I believe the epi-on will become the preferred way to do cross-linking and will eventually supplant epi-off.”

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Pictured from L-R: Emmett T. Cunningham, Jr., MD, PhD, MPH, Partner – Clarus Ventures, Laurent Attias, Head, Global Commercial Strategy - Alcon, Calvin W. Roberts, MD, Sr. Vice President, Chief Medical Officer - Bausch + Lomb, Jane E. Rady, Divisional VP, Business Development - Abbott Medical Optics, Quinton Oswald, President &CEO Neurotech

The day concluded with the Industry Perspectives session which included panelists from some of the market leading companies.

Among other topics throughout the day, they discussed why they have not yet become involved with corneal cross-linking. According to Laurent Attias of Alcon, there are clearly benefits for keratoconus patients and for improving some refractive surgery outcomes; the key unanswered questions relate to the long-term clinical outcomes.

Calvin W. Roberts, MD of Bausch + Lomb said that the key issues surround intellectual property, and the risk associated with making a large investment in a field with potentially low barriers to entry. Jane E. Rady of AMO echoed the concerns regarding IP and long-term safety, and also expressed concerns regarding cross-linking being used to treat corneas, particularly during refractive procedures, that may be healthy and not actually require treatment.

To watch the detailed presentation visit www.ois.net.

Be sure to join us as the OIS franchise continues with the next event being held on October 16th at the Palmer House Hilton in Chicago directly preceding the annual AAO meeting.

AAO OCTOBER 16, 2014 PALMER HOUSE, HILTON CHICAGO, IL

APRIL 16, 2015 HILTON SAN DIEGO BAYFRONT

SAN DIEGO, CA REGISTER TODAY!

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OIS brings you a new & interactive SuperSite OIS Events

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View details and register for upcoming meetings.

View videos of all the recent presentations with embedded power-point slides.

Featuring original content and other industry news that can be sorted and searched by category and interest.

PLUS: OIS Members Section

Connections at Your Fingertips

Create a profile where you can connect and interact with each other. Try the “Share & Discuss” social feed and “Contribute” features that allow you to write a blog style post and upload an article, press release or presentation to share with the OIS community.

So sign up today and get the conversations flowing!

Think of it as the Facebook for the leaders in ophthalmic innovation.

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THIS REPORT IS SPONSORED BY:

For information regarding speaking, sponsorship, or program content please contact: CRAIG SIMAK Executive Producer craig@ois.net | 516.307.0743