Avedro Receives CE Mark for Mosaic System, Announces CEO Transition

Avedro has received CE Mark clearance for its Mosaic System, according to a company news release. The Mosaic System has the potential to provide nonsurgical improvement for low myopia with the Photorefractive Intrastromal Cross-linking (PiXL) procedure. The Mosaic system is now commercially available outside the United States.

Avedro also announced that, following the completion of a recent US$32 million round of financing, David Muller resigned as Chief Executive Officer in order to pursue other opportunities. “On behalf of the Board and all the Avedro employees, I want to thank David for his tireless efforts,” Gil Kliman, MD, Interwest General Partner and member of the Avedro Board of Directors, said in the news release. “Ophthalmologists around the world have David to thank for the advances in corneal crosslinking that Avedro researched, developed, and commercialized around the world under his leadership.”

Brian Roberts will lead the company while the board conducts a search for Avedro’s next CEO.

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Refractive Surgeons More Likely than the General Population to Undergo Laser Vision Correction

The Refractive Surgery Alliance (RSA) announced that, based on data published in the Journal of Cataract & Refractive Surgery,¹ nearly two-thirds (62.6%) of refractive surgeons who were candidates for refractive surgery have had their vision corrected. According to a news release, the study also reported that more than 91% of all refractive surgeons recommend refractive surgery to their immediate family members.

“Technical advances have made refractive surgery not only safe but extremely accurate,” Guy M. Kezirian, MD, MBA, Founder of the RSA and lead author of the study, said in the news release. “The fact that the people who know the most about refractive surgery are having the surgery performed on themselves and their families speaks volumes about the benefits of this procedure.”

The 22-question Global Survey on Refractive Surgery in Refractive Surgeons was sent by email to 250 ophthalmologists randomly selected from a database of 2,441 ophthalmologists known to have performed laser vision correction (LVC) at some point in the past decade. Responses were solicited by email with subsequent telephone reminders to nonresponders.

According to the study, responses were received from 248 (99.2%) of 250 queried individuals, of whom 232 (92.8%) met the protocol criteria of currently working as refractive surgeons. Of the 232 participants, 161 (69.4%) reported that they had refractive errors potentially amenable to treatment with LVC, not including presbyopia. Of the 161 ophthalmologists with treatable refractive errors, 54 (33.5%) reported they were not candidates for LVC for a variety of reasons, and 107 (66.5%) reported they were candidates for LVC. Of the LVC candidates, 62.6% reported that they had undergone an LVC procedure. Of the overall 232 subjects, more than 90% recommend LVC for adult members of their immediate family.

“Prospective surveys that define the study population before they present the questions are scientifically valid because they eliminate response bias,” Greg Parkhurst, MD, incoming RSA president and study author, said in the news release. “This approach is far more valuable than using results from people who were motivated to respond to a poll. The high response rate makes this extremely reliable.”

The study shows refractive surgeons are more than four times more likely to have refractive surgery than the general population. “Many patients just don’t know about refractive surgery,” study author Jason P. Brinton, MD, said in the news release. “There is a need for public education about the benefits. Several recent studies have shown that refractive surgery generally provides better vision than glasses or contact lenses, is much safer than contact lenses and is far cheaper over time. We need to get the word out.”

1. Kezirian GM, Parkhurst GD, Brinton JP, Norden RA. Prevalence of laser vision correction in ophthalmologists who perform refractive surgery. J Cataract Refract Surg. 2015;41(9):1826-1832.

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Refractive Surgery Pioneer Lee Nordan, MD, passes away

Lee T. Nordan, MD, an internationally recognized authority on refractive surgery, died December 22 at the age of 69.

Dr. Nordan was most recently a practice consultant at North County Laser Eye Associates, in Carlsbad, California. Prior to that, he was a practicing cataract and corneal transplantation surgeon and an assistant clinical professor of ophthalmology at the Jules Stein Eye Institute at the University of California, Los Angeles (UCLA).

According to his practice biography,1 Dr. Nordan completed his cornea and external disease fellowship at the Jules Stein Eye Institute in 1978. He received his MD from the University of New Mexico in 1974. He was trained by José I. Barraquer, MD, of Bogota, Colombia, the founder of lamellar refractive surgery. His accomplishments include five US patents related to eye surgery, including a patent for a multifocal IOL.

Dr. Nordan was a well-published author, with many articles and a major textbook in refractive surgery, “The Surgical Rehabilitation of Vision,” to his credit. He also served on the editorial board of CRST Europe’s sister publication, CRST, for several years in the 2000s and was influential in shaping much of the publication’s content during its early years.

Dr. Nordan was also involved in developing and funding several startup companies both in and outside ophthalmology. He received more than $1 million from Johnson & Johnson for a medical technology venture, according to his company profile at Freedom Meditech, where he served on the scientific advisory board. He was also an early-stage investor and advisor to the beverage company South Beach (SOBE) prior to its sale to PepsiCo.

In a 2011 interview with CRST,² Dr. Nordan spoke about his decision to stop practicing ophthalmology. “Ophthalmology offered me just the right combination of interaction with patients, surgery, and opportunities for product innovation. After 35 years of activity within the same profession, I felt it was appropriate to leave on a high note, rather than when my surgical skills were declining or when I had stopped learning new techniques and ideas. Improving ocular function and decreasing the incidence of ocular disease are a higher calling that will never become obsolete.”

In the CRST article, Dr. Nordan credited Dr. Barraquer and Thomas Pettit, MD, his cornea fellowship mentor, as his main influences in pursuing a career in corneal lamellar surgery. “I fought hard for my point of view, taught my techniques to other members of the profession who were interested, and never knowingly had a lapse in integrity within the profession or industry. I am proud of that record.”

1. North County Laser Eye Associates. http://www.nclasik.com/html/meet.html#lee. Accessed December 22, 2015.

2. Nordan L. 5 Questions with Lee T. Nordan, MD. Cataract & Refractive Surgery Today. July 2011: 74.

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Dry Eye Disease May Not Worsen Over Time in Most Patients

Dry eye disease (DED) does not necessarily worsen over time in most patients, a retrospective survey-based study in Ophthalmology suggests.¹

Jeffrey P. Leinert, MS, of the Harvard T. H. Chan School of Public Health in Boston, and colleagues analyzed the medical records of 398 men and 386 women who reported a diagnosis of DED and responded to a questionnaire about change in disease since diagnosis. Men included in the study ranged in age from 60.2 to 97.3 years and had DED an average of 10.5 years, and women ranged in age from 61.2 years to 89.9 years with an average disease duration of 14.5 years.

The investigators developed three subscales using factor analysis of questionnaire responses: ocular surface symptoms, vision-related symptoms, and social impact. They examined correlates of worsening on each subscale, obtained medical records from a subset of 261 study participants, and examined changes in clinical signs of DED over time.

The average duration of DED was 10.5 years. Worsening was reported by 24% of patients for ocular surface symptoms, 29% for vision-related symptoms, and 10% for social impact. Factors associated with worsening on at least two of three subscales included a previous report of severe DED symptoms (OR, 2.17 for ocular surface symptoms; OR, 2.35 for vision-related symptoms), spending more than US$20 per month on DED treatments (OR, 1.80 for ocular surface symptoms; OR, 1.99 for vision-related symptoms), history of blepharitis or meibomian gland dysfunction (OR, 1.57 for vision-related symptoms; OR, 2.12 for social impact), and use of systemic beta-blockers (OR, 1.62 for ocular surface symptoms; OR, 1.84 for vision-related symptoms; OR, 1.86 for the social impact of DED).

Presence of corneal staining based on review of medical records was associated with use of level 2 or higher DED treatments (OR, 1.54; CI, 1.01–2.36), a previous report of severe DED symptoms (OR, 1.79; CI, 1.07–3.00), having a tear breakup test performed (OR, 2.73; CI, 1.72–4.36), and having blepharitis or meibomian gland dysfunction (OR, 0.59; CI, 0.35–0.98).

“A proportion of patients with DED experience worsening over time, tending to report with more severe symptoms earlier in the disease,” the study authors wrote. “Forthcoming data on the natural history of DED from prospective studies should help clarify some of the limitations of this retrospective study.”

1. Leinert JP, Tarko L, Uchino M, Christen WG, Schaumberg DA. Long-term natural history of dry eye disease from the patient’s perspective [published online ahead of print November 21, 2015]. Ophthalmology. doi:http://dx.doi.org/10.1016/j.ophtha.2015.10.011.

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Geuder Expands Product Range With Sterile Trephine and Cornea Punches

Geuder has expanded its trephine portfolio with sterile single-use trephines, single-use vacuum trephines, sterile single-use trephine punches, and single-use vacuum trephine punches from SurgiStar, the company said in a
news release.

According to Geuder, the portfolio of different diameters, from 2.5 mm up to 18 mm in steps of 0.25 mm, and different versions of long and short trephines, radial and vacuum trephines, trephine punches, and vacuum trephine punches complete the product range.

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Leica Microsystems Launches Ophthalmic Microscope Platform

Lecia Microsystems launched the Proveo 8, the core of a new ophthalmic microscope platform for cataract and vitreoretinal surgeries, according to a news release.

The Proveo 8 is equipped with breakthrough innovations such as FusionOptics and CoAx4 Illumination. FusionOptics is an exclusive technology from Leica that combines 40% increased depth of field with high resolution, providing surgeons with a texture-rich image from the edges of a detached membrane to the periphery of the retina without refocusing. Another Leica exclusive feature, CoAx4 Illumination, reportedly delivers light through four individual beam paths and allows for adjustment of the illumination diameter. This results in a constant red reflex and high-contrast visualization without compromise for the main surgeon or the assistant.

The Proveo has been designed to easily integrate innovative surgical technologies such as IOL guidance systems for precise IOL positioning, intraoperative OCT to observe ocular tissue microstructures, or three-dimensional heads-up surgery.

–Compiled by Steve Daily, Executive Editor, News;
and Callan Navitsky, Senior Editor

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Q&A: Allergan President and CEO Brent Saunders on the Future of Eye Care After Pfizer Merger

By Stephen Daily, Executive Editor, News

In November, Pfizer and Allergan announced that they had entered into a definitive merger agreement to combine in a stock transaction valued at about US$160 billion. The takeover, which is expected to close in the second half of 2016, would be the biggest deal ever in the health sector. It was announced that Brent Saunders would serve as the president and chief operating officer of the combined company. In an interview with BMC, Mr. Saunders spoke about the deal and specifically what it potentially means for the future of Allergan’s eye care business and operations.

Stephen Daily: Following the announcement of the merger, you said that Pfizer will expand the reach of Allergan’s established portfolio by using its existing commercial capabilities, infrastructure, and vast global footprint. How do you believe Pfizer will help the existing high-growth therapeutic areas that Allergan is currently in? How does the combination increase the ability to develop drugs and get them onto the market?

Brent Saunders: The way I think about it is [that] one of our most important goals is to get our medicines and therapies to patients around the world. Today, we do that in roughly 60 markets around the world. Pfizer does it in roughly 160 markets around the world. So this transaction will enable us to significantly expand our international presence and very quickly begin to bring medicines to people in 100 countries in the world that we don’t currently sell our products in.

That has enormous opportunity for physicians and patients around the world to get the access, not only to our current portfolio or our established portfolio, but also to the drugs that are coming in our pipeline. Ultimately, I think that’s a real win for physicians, eye care professionals, and patients.

Mr. Daily: At a Forbes summit in December, you said one of the benefits of the merger, in addition to Pfizer’s large R&D capabilities, is that some of the applications from Pfizer’s specialties, such as oncology, may be used to develop new molecules in Allergan’s existing portfolio, such as ophthalmology. Can you discuss how you believe Allergan’s portfolio can benefit from Pfizer’s current offerings?

Mr. Saunders: At Allergan today, we employ a strategy called open science. In eye care, we have some discovery capabilities and we also have deep development and regulatory capabilities in eye care. Under the proposed merger with Pfizer, at closing, we would have more significant discovery capabilities. Some of those exist today in areas like oncology or central nervous system that could have application to eye care R&D, but they also could be just investing in building more capabilities to complement existing Allergan discovery capabilities.

I really do think that this particular transaction could be a huge win for the eye care community in that you could see Allergan go even deeper into investing in R&D for unmet need in eye care.

Mr. Daily: You have a long-term relationship with the eye care community and have said that you would like to continue to pursue opportunities for growth in this field. At the Ophthalmology Innovation Summit prior to the Pfizer merger being made official, you touted the 17 products in Allergan’s eye care pipeline. Taking an objective view of the eye care market in the near and long term and under the large umbrella of Pfizer, how big a focus will eye care be under the combined company? Do you feel ophthalmology presents a long-term financial growth opportunity for the new Pfizer?

Mr. Saunders: Yes, I think ophthalmology and eye care will be a top therapeutic area for the combined company. We will be a global leader in eye care. We will have a deep commitment to eye care. I think you’ll see that—almost like you saw with the Actavis-Allergan merger, where we took a company with a deep history and commitment to eye care and tried to elevate our game with respect to our commitment to medical education, science, and product development—I think you’re going to see that happen again and perhaps even be a larger step in support of the eye care community.

Eye care is a terrific area of medicine. Ophthalmologists and optometrists are fantastic practitioners. The new combined Allergan-Pfizer will be, as I said, a world leader, and there’s still so much unmet need. [There are] still so many people that are suffering for either known reasons or unknown reasons, and, ultimately, where I’d like to see us go is not just treating diseases but curing them. I think this combination puts the new Pfizer, the combined Allergan-Pfizer, in a position to start the dialogue around cures versus just treatment.

Mr. Daily: Will eye care be treated as its own unit under the combined company?

Mr. Saunders: It’s a bit early to say with certainty what the structure will look like, but Pfizer today operates under what are called global business units or GBUs, as they call them. Under that construct, eye care would become a global business unit, and more or less run independently.

Mr. Daily: I think many medical professionals in ophthalmology liked the fact that Allergan retained its name following the Actavis-Allergan merger. It was announced that the combined company will be called Pfizer PLC, so what will become of the Allergan name? Will it remain a unit or a brand of Pfizer, or will it be eliminated?

Mr. Saunders: I think, at this early stage, anything is possible. Obviously, I understand and appreciate the value of the Allergan name, and so we will study it and do it very thoughtfully. Clearly, the company will be called Pfizer PLC, but if there’s an opportunity to preserve the [Allergan] name for good reason, I’m very open-minded to that.

Mr. Daily: In recent years, Allergan has introduced some devices, particularly in the aesthetics business. However, Pfizer is more of a traditional drug company. Do you see the possibility for the new combined company to add devices to its portfolio?

Mr. Saunders: I don’t think our strategy will change with respect to eye care as it exists today. As you know, as of late, we have moved into devices with both the XEN45 stent and the Oculeve dry eye device. We will continue to look for ways to solve for unmet need, whether it be drug or device. Obviously, we need to do things that we’re good at. Capital equipment, for example, hasn’t been an area where we’ve had tremendous experience, but if ultimately there’s an opportunity to better serve our customers and solve for unmet need through capital equipment, we would be open to that as well.

Mr. Daily: Finally, a lot of innovation in ophthalmology is the result of long-term relationships between industry and medical professionals. There is concern that as more of the traditional ophthalmic companies become part of much larger companies, some of those relationships, and thus the deals and innovation that come from them, could be in jeopardy. What would you say to this?

Mr. Saunders:I would say it has nothing to do with whether or not these companies are parts of larger companies or standalone companies. I think it goes to attitude and focus and priorities inside a company. I think you’re absolutely right; to be effective in eye care and some other specialty therapeutic areas, you need to be in tune with your customers. You need to understand what they need to better serve patients. You need to get their perspective on innovation and science, and you need to understand where they see unmet need. Whether you’re a big company, small company, or part of a multinational company, it isn’t really part of that discussion. It’s about your commitment and how you want to live up to that commitment. In my new role in this combined company, I will be 100% committed to the eye care community and making sure that we continue to only improve upon our relationships with industry in a compliant, lawful way, but also in a very meaningful way.

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