Medical Device Daily Contributing Writer

NEW ORLEANS — The oft-repeated Cajun expression in this fun loving town, "laissez les bon temps roulez," translated as let the good times roll may be an accurate way of summarizing the upbeat mood at this year's annual meeting of the American Academy of Ophthalmology (AAO; San Francisco).

The AAO is by far the largest ophthalmic meeting of each year, typically drawing in excess of 25,000 persons from around the world. Notwithstanding the stringent regulatory climate at the FDA, reimbursement cuts and a decline in access to traditional funding sources like venture capital, the ophthalmic surgery field has generally fared much better than other medical device sectors.

It has clearly attracted the interest of large device companies. For example, in August Abbott Laboratories (Abbott Park, Illinois) purchased the venture capital-backed femtosecond laser manufacturer Optimedica (Sunnyvale, California) for $250 million in cash, plus potential milestone payments of an additional $150 million. Not surprisingly, Medical Device Daily's industry sources have indicated that several other large device companies have a keen interest in the ophthalmic space.

Preceding the AAO was the fifth annual Ophthalmology Innovation Summit (OIS), which was organized by International Business Forum (Massapequa, New York). Attendance by more than 800 persons was very impressive and further solidified its stated purpose of supporting 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.

It is partially because of this tightly woven set of relationships, coupled with the fact that there are many diseases and conditions of the eye that are still not treated optimally that makes ophthalmology an attractive, relatively high growth segment of the medical device industry.

Cataract surgery and implantation of an intraocular lens (IOL) is the most commonly performed surgery in the U.S. today, with approximately 3.4 million procedures performed annually. Globally, it is estimated that there are in excess of 20 million procedures performed per year.

Whereas the results for LASIK refractive surgery are superb, with an estimated 93% of eyes achieving a correction within 0.5 diopters (D) of the intended correction and 98% of eyes achieving 20/25 or better, the "dirty little secret" of cataract surgery is that only about 60% of eyes attain this high level of visual acuity.

CEO Tom Frinzi of venture capital-backed Wavetec Vision (Aliso Viejo, California) described the disparity between LASIK and cataract results in his OIS talk as an "accuracy gap." He discussed his company's intraoperative aberrometry technology, which is tradenamed the ORA system with VerifEye.

Wavetec's device provides intra-operative refractive information that enables on-demand course correction so that the ophthalmic surgeon can "get it right – right on the (operating room) table." ORA is fully compatible with and attaches to existing surgical microscopes.

Frinzi reported that surgeons using the ORA system, coupled with the recent upgrade of VerifEye, are providing their cataract patients with superior outcomes. To wit, 87% of patients are attaining a visual acuity within 0.5D of their intended correction. For surgeons that have added a femtosecond laser to their practice, that percentage jumps to 97%. And, in one center, a surgeon with a series of 50 patients has reported an astonishing 99% of his patients within 0.5D.

The outstanding benefits of this technology has resulted in an impressive growth in the Wavetec installed base, which surged from only 48 systems in 2Q-2012 to 252 units at the close of 3Q13. Quarterly procedural volume has similarly mushroomed, from 5,555 in 1Q12 when ORA was launched to over 22,000 in 3Q13. Frinzi also pointed out that practices using ORA are enjoying a significant 27% increase in their lucrative premium IOL volume, which substantially buoys the overall profitability of their practice.

Another venture capital-backed company, Clarity Medical Systems (Pleasanton, California) presented at OIS and introduced its long awaited and highly anticipated HOLOS IntraOp intraoperative cataract system at this meeting. HOLOS, which has been in development for seven years, appears to offer a further enhancement to wavefront aberrometry technology. The company touts the system as the first real-time, continuous "movie" of refraction throughout the surgical procedure, which CEO Keith Mullowney fervently believes will provide even better IOL selection and enhanced visual results. Thus far, minimal clinical data is available, as the system was completed just prior to the AAO.

Clarity's exhibit booth here was packed every day with surgeons eager to learn about its features and benefits. It is strongly supported by a highly respected group of ophthalmic surgeons, a veritable "who's who" in this field today. A well-attended session here titled "Cataract Surgery: The Cutting Edge," highlighted HOLOS as one of the most exciting new cataract-related technologies

Mullowney, who has headed up Clarity for many years, told MDD in an interview that he hopes that the first HOLOS shipments will begin in the next several weeks, with production ramping up in 2014.

Clarity is also the developer, manufacturer, and marketer of RetCam, the leading pediatric ophthalmic digital imaging system with more than 1,400 systems installed worldwide. Its unique ability to diagnose retinopathy of prematurity, has fostered discussion in the pediatric retinal community that the RetCam test become be adopted as a universal screening device for all newborns. In his OIS talk, Mullowney indicated that Retcam currently generates about $20 million in global sales and has been growing at a 20% compound annual rate for the past several years.

One of the busiest booths in the exhibit hall was Iridex (Mountain View, California), which has recently been showing robust sales growth and improving profitability under the astute management of CEO Will Moore. The company, which has a sterling reputation in the ophthalmic laser space for two decades, sponsored a series of informative talks at its booth on the myriad applications for its laser products.

David Dickman, MD, of the Universal Eye Center (Rolesville, North Carolina) discussed Iridex's 532 nm micropulse laser in a talk titled "A Comprehensive Laser for the Comprehensive Ophthalmologist: Clinical and Economical Advantages." He noted that the average income for ophthalmologists has dropped (in 2012 dollars) from about $411K in 1988 to $251K in 2012, while the costs of equipment to set up or run an office have skyrocketed and reimbursement rates have declined significantly. Thus, a comprehensive ophthalmologist needs to be keenly aware of buying productive and reasonably priced equipment.

When he opened his practice about 18 months ago, Dickman opted to buy an "all purpose" laser and selected the Iridex 532, which he quipped "has a least a dozen uses." He described the laser as a technology that "chops" continuous wave laser emission into spaced, repetitive micropulses that allows for finer control of thermal effects, a lower energy per pulse and tissue cooling between pulses. The net result is that it provides equivalent or superior clinical outcomes and does not cause detectable tissue damage at any time point post-operatively.

Importantly, he indicated that the heated tissue that remains viable after MicroPulse laser treatment produces a stress response and induces beneficial intracellular biological factors that are primarily anti-angiogenic and restorative.

He cited efficacy data for glaucoma that was presented in a June 2013 Iridex-sponsored webinar that showed a 30% reduction in intraoperative pressure using a 1000 mw application of energy.

In addition to the treatment of glaucoma, this Iridex laser is adept at treating diabetic macular edema (DME). A very recent estimate from the International Diabetes Federation (Brussels) disclosed that there are 382 million diabetics in the world, which is equivalent to a global prevalence rate of 8.4% of the adult population. That number compares to 371 million cases in 2012. By 2035, the organization predicts the number of cases will soar by 55% to a staggering 592 million.

Several talks at the Iridex booth addressed DME treatment options and indicated that while anti-VEGF intravitreal injection therapy (e.g., Lucentis or Avastin) is highly effective for treating DME, it is extremely expensive and typically require many injections annually. Some patients even require a monthly injection, which can impose a big burden on the patient or their caretaker.

Very importantly, the combination of a micropulse laser and anti-VEGF injections provides a superior patient outcome, lower costs to the healthcare system and a significant increase in the ophthalmologist's income.

Both traditional and micropulse lasers have demonstrated excellent efficacy for DME but according to Sam Mansour, MD, clinical professor in the department of ophthalmology George Washington University (Washington) the latter has been shown to be much safer, with no detectable retinal damage up to 10 years after ten years.

In an article in Retina Today, Mansour stated that "the goal of DME therapy is to achieve the greatest reduction in macular thickness in the shortest amount of time with the least amount of side effects and with the greatest duration. I am able to achieve that by combining micropulse laser therapy and pharmacologic VEGF inhibitors.

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