Conference’s ‘vision’ allows industry leaders second sight

By Larry Haimovitch

Medical Device Daily Contributing Writer

April 27, 2012

CHICAGO – The first ever Ophthalmology Innovation Summit (OIS) held in conjunction with the annual American Society of Cataract and Refractive Surgeons (ASCRS; Reston, Virginia) took place here late last week.

OIS (www.ophthalmologysummit.com) , which has had three very informative and well-attended meetings in conjunction with the annual meeting of the American Academy of Ophthalmology (San Francisco), was organized by International Business Forum (Massapequa, New York).

The conference key faculty included Emmett Cunningham of Clarus Ventures (South San Francisco), Bill Link and Gil Kliman of Interwest Partners (Menlo Park, California), Richard Lindstrom, MD, ophthalmic surgeon from Minnesota Eye Consultants (Minneapolis) and Jim Mazzo, president of Abbott Medical Optics, a division of Abbott Laboratories (Abbott Park, Illinois).

The purpose of the OIS 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.

The conference was kicked off by Bill Link, perhaps the most successful venture investor in the ophthalmic device space, who noted that "innovation in surgical ophthalmology is gaining, not losing, momentum even though there are myriad challenges."

Acknowledging the more stringent regulatory environment, he admitted that the "times have changed . . . but he ended on an upbeat note with the comment that "it has never been better (because) of the still immense unmet needs."

Glaucoma, the world's second leading cause of blindness, may be a poster child for unmet clinical needs. To wit, there has not been a new pharmaceutical agent approved since 1996 and the surgical techniques, which are highly invasive and often fraught with serious side effects, are also many decades old.

World renown ophthalmic surgeon, Ike Ahmed, MD, assistant professor at the University of Toronto, delivered an outstanding talk titled "MIGS: Unmet Needs and Opportunity Assessment." He defined MIGS or micro-invasive glaucoma surgery, as a procedure in which a micro-incision is made prior to placing a tiny stent-like device that facilitates the outflow of aqueous from the clogged trabecular meshwork. This procedure is sometimes described as an ab interno, because the device is lodged entirely within the eye.

Ahmed indicated that the management of glaucoma has not changed in 40 years and that patients, especially in the mild-to moderate category are prime candidates for this new category of devices. He said that this group, which he called the "middle class," accounts for about 60% of all glaucoma patients.

"We need to treat this group of patients sooner, before their disease gets too advanced," said Ahmed.

Ahmed noted that this approach holds great promise but cautioned that these devices will not provide "dramatic" benefit in intraocular pressure (IOP) reduction and should be viewed as a safe and effective intervention that will prevent disease progression.

In a MIGS panel discussion later, Lindstrom described this approach as a "lifestyle enhancer," because it will enable patients to lower their dependence on glaucoma medications.

There are several private companies that have developed this type of product, including four venture capital-backed California-based companies Glaukos (Laguna Hills), Transcend Medical (Menlo Park), Aquesys (Irvine) and iVantis (Irvine). Another company in this space is Innfocus (Miami), which is not known as well as the others but has quietly been developing some impressive early clinical data from outside the U.S.

Glaukos is clearly in the lead with its iStent device, which creates a patent opening into Sclemm's canal, the eye's natural drainage site. Founded about a decade ago, it was the first company to initiate clinical trials. Glaukos gained an FDA panel recommendation in July 2010 and final FDA approval is expected to occur in the near future.

The company has also developed second and third generation devices that are expected to improve its patient benefits even further. CEO Tom Burns noted tremendous clinical progress, with 18 clinical trials underway or completed, the enrollment of over 4000 patients worldwide and 22 peer-reviewed articles.

Glaukos has paved the way for widespread reimbursement coverage after FDA approval and faster clinical adoption of its products by successfully petitioning CMS for two separate Category III CPT codes (codes 0191T and 0253T). Its competitors will all be the beneficiaries of this groundwork after they receive their FDA approvals.

Transcend has made considerable progress in recent years, with its Cypass Micro-Stent technology. It creates a direct path for aqueous outflow from the anterior chamber to the suprachoroidal space, thereby enhancing a natural drainage pathway to lower IOP. In addition the device can be delivered with a proprietary gonioscopy-free delivery system, which simplifies the procedure considerably.

At the ASCRS meeting, Transcend released 12 month data from the European CyCLE Study. Patients receiving the CyPass device in combination with cataract surgery showed a 34% mean decrease in IOP at 12 months with a concomitant 35% mean reduction in IOP lowering medications.

Commenting on these results Ahmed said that " . . . the CyPass Micro-Stent is the most studied minimally invasive device that takes advantage of the high potential, pressure-lowering physiology of the suprachoroidal drainage path. Implanting the CyPass device is a very straightforward procedure, resulting in IOP lowering and quick recovery."

The company has completed enrollment of about half the 505 patients required for its COMPASS domestic pivotal trial. It also has two European trials that are also ongoing.

Aquesys CEO Ron Bache discaussed his company's collagen-derived, gelatin implant, which becomes soft and flexible after delivery with its pre-loaded and disposable, "IOL-like" inserter. Bache described the procedure as "versatile, straightforward, removable and repeatable if required."

The company's international clinical results to date are promising, with 24 month follow-up on 118 patients showing a 37% reduction—or about 9 millimeters – in IOP from best medical therapy and a 48% average reduction in the nmber of glaucoma medications required.

Aquesys has already secured CE mark and is currently enrolling patients in its U.S. IDE triaI.

Intra-operative aberrometry was another major focus of the conference. This technology, which intra-operatively provides the cataract surgeon with a more accurate IOL selection, addresses a major shortcoming of today's cataract surgery. Historical, pre-operative intraocular lens power formulas have been moderately successful, with the result that an estimated 50% of patients have a 0.5 diopters (D) shortfall from 20/20 vision. Conversely, at least 85% of LASIK patients are estimated to achieve 20/20 or better and 100% are at 20/40.

In addition, more than 40% of cataract patients are dissatisfied, they need glasses or request secondary enhancement surgery, which can reduce the surgeon's procedure profit by up to 50%. There is a growing realization in the cataract surgeon community that they need refractive measurement when it matters most – intra-operatively.

Vance Thompson, MD, a highly-respected ophthalmic surgeon from the Sanford Clinic (Sioux Falls, South Dakota) stated it succinctly when he opined in a comprehensive presentation at OIS that intra-operative aberrometry "is an idea whose time has come."

A panel of illustrious cataract and refractive surgeons strongly echoed Thompson's sentiments, with comments like "I cannot do surgery without it", and "I strongly recommend it for all my patients undergoing cataract surgery."

Privately owned, venture capital-backed Wavetec Vision (Aliso Viejo, California) is the clear industry leader, marketing the ORA system with OptiWave technology. Its optimized algorithms have been clinically proven to boost the accuracy of intraoperative refractive measurement, providing increased confidence in a surgeon's IOL selection and enhancing visual outcomes.

CEO Tom Frinzi has reported that about 80% of ORA cataract surgery patients are within 0.5D of their intended correction, a substantial improvement relative to the 50% of patients who are not exposed to ORA. Moreover, Frinzi expects these results to improve to at least 85% within 0.5D of patients in the future.

Privately-owned Clarity Medical Systems (Pleasanton, California) is developing its proprietary HOLOS IntraOp wavefront aberrometry system for a variety of applications, including better IOL selection for cataract surgery. The company touts the system as the first real-time, continuous "movie" of refraction throughout the surgical procedure. Clarity believes that this real-time feature will provide even better IOL selection and enhanced visual results than the ORA system.

HOLOS, which has been endorsed by several prominent ophthalmic surgeons, is in the advanced stages of development. CEO Keith Mullowney told Medical Device Daily that commercial shipments are expected to commence sometime in 2013.

2012 Ophthalmology Innovation Summit

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