By Larry Haimovitch

Medical Device Daily Contributing Writer

April 29, 2013

SAN FRANCISCO— The second annual Ophthalmology Innovation Summit (OIS) held in conjunction with the American Society of Cataract and Refractive Surgeons (ASCRS; Reston, Virginia) annual gathering took place here last week. International Business Forum (Massapequa, New York) organized the meeting.

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.

Bill Link from Versant Ventures (Menlo Park, California), the most renowned and perhaps the most successful venture investor in the ophthalmic surgical space, led off the conference with a talk titled “High Impact Innovation in Surgical Ophthalmology.” He ticked off several key criteria that are driving or attracting innovation and these are shown in the table below.

Table 1
Key Criteria Driving/Attracting Innovation

  1. Large, Accessible Market….unmet need

  2. Disruptive Technology

  3. Amazing Team

  4. Predictable Regulatory Pathway….the shorter, the better

  5. Solid Reimbursement

  6. Access to capital….capital efficient

  7. Strong, committed corporate leaders

He noted that while ophthalmology has made incredible technological progress in the past two decades, there are still several unsolved or unmet needs. In particular, he said that there is a “huge opportunity” in the treatment of dry eye, which he said is “currently underserved and attracting attention.”

Link cited two examples: Restasis, an ophthalmic emulsion which helps increase the eyes’ natural ability to produce tears. It has been a huge commercial success for Allergan (Irvine, California). A second case in point is the recent acquisition of privately owned, VC-backed SARCode (Brisbane, California) by publicly owned Shire PLC (Dublin, Ireland). Shire is buying SARCode for $160 million upfront plus milestones for its topical dry eye agent LIFITEGRAST, which is now in a Phase III trial. Shire hopes to launch this drug, which has been developed to treat chronic inflammation associated with dry eye disease, by 2016.

As further indication of the ebullient status of the global dry eye market, privately owned, VC-backed TearScience (Morrisville, North Carolina) recently raised up to $70 million from HealthCare Royalty Partners (Stamford, Connecticut). The funding is targeted toward fully implementation of its its global commercialization efforts and to establish the TearScience system as the “Standard of Care” for evaporative dry eye.

Despite his upbeat presentation, Link acknowledged several “headwinds” which are negatively impacting the industry’s progress. Conversely, he asserted that there are numerous “tailwinds” that are offset factors, but he said that the “headwinds are stronger than the tailwinds, which should provide rewards for high impact innovation.” These are detailed below.

Table 2
Headwinds…..and Tailwinds

There were several very interesting panel discussions at the meeting. One of these panels featured several prominent ophthalmic surgeons and CEOs of cataract-related devices. Two innovative products, femtosecond laser-assisted cataract surgery  (FLACS) and Intra-operative aberrometry, clearly captured the limelight.

The former, introduced to the cataract surgery market about four years ago, has been growing very rapidly. Shareef Mahdavi, president of SM2 Strategic (Pleasanton, California) estimated that in 2012 there were 138 FLACS systems installed, tripling the 2011 base. He projected even stronger growth in 2013, with an additional 140 installations, lifting the installed base at the end of 2013 to 278 units.

Mahdavi estimated that FLACS procedures currently account for only 2.3% of total cataract surgeries in the U.S. For perspective, Marketscope (St. Louis) estimated that there will be approximately 3.7 million cataract surgeries in the U.S. in 2013, thus indicating that FLACS now accounts for approximately 85,000 procedures annually.

More importantly, in a recent survey Mahdavi found that in cataract surgery practices where a FLACS laser has been installed, the percentage of FLACS procedures jumps to an impressive 30% of all cataract cases. Importantly, in these practices, 60% of the patients have opted for a more expensive premium intraocular lens (IOL). This IOL category includes toric, multi-focal and accommodative IOLs. In addition to a better refractive outcome for the patient, premium IOLs are far more profitable to the surgeon’s practice.

In an interview with Medical Device Daily, Shachar Tauber, MD, section chair ophthalmology from Mercy Hospital (Springfield, Missouri) remarked that since acquiring two FLACS systems from OptiMedica (Sunnyvale, California) in October 2012, his hospital is doing 100% of its cataract procedures with femtosecond technology. Mercy performs an estimated 4000 cataract procedures per year.

“We feel that this is superior technology and as a result, we are offering it to all of our patients without an extra charge.”  Shachar also said that this is “the da Vinci robot for cataract surgery.”

This contrasts with the typical FLACS surgeon, who in Mahdavi’s survey revealed an average FLACS upcharge of $1058 per eye with a conventional IOL implant.

Parenthetically, OptiMedica was clearly a star performer throughout ASCRS. Its very attractive exhibit booth was virtually always filled with doctors and there were 31 papers discussing the stellar results on its Catalys FLACS system. An evening symposium titled “Catalys Precision Laser System: Laser Cataract Surgery Without Compromise,” featuring some of the most renown cataract surgeons in the world, was jam packed, standing room only event.

Intraoperative aberrrometry, which intra-operatively provides the cataract surgeon with a more accurate IOL selection, was also prominently featured here. It addresses a major shortcoming of today's manual cataract extraction, that is about 50% of patients have a 0.5 diopters (D) shortfall from the targeted refractive goal. Conversely, at least 85% of LASIK patients are estimated to achieve the refractive goal (typically 20/20) or better and virtually 100% are at 20/40.

Surveys have shown that about 40% of cataract patients are dissatisfied, resulting on the need for glasses or secondary laser enhancement surgery. This is time consuming for both the patient and surgeon and can significantly reduce the surgeon's procedure profit.

In a panel discussion on this topic, David Chang, MD, succinctly said that this technology is a “no brainer, it improves clinical outcomes significantly”

Privately owned, venture capital-backed Wavetec Vision (Aliso Viejo, California) is the clear-cut industry leader, with its ORA brand. CEO Tom Frinzi told MDD Itthat his company has more than doubled its installed base since it re-launched the system 16 months ago and that he expects Wavetec will exit 2013 with an installed base in excess of 300 systems.

Wavetec’s clinical results have improved with its new VerifEye monitoring hardware upgrade, which provides continuous refractive information. In his presentation here, Frinzi noted that VerifEye utilizes a faster processor, which shortens measurement times. More importantly, it generates high quality measurements that result in greater accuracy and consistency. Wavetec will begin shipping its ORA device with VerifEye in 3Q-2013.

In a series of about 300 patients using ORA and VerifEye and some treated with FLACS, 84% of the patients were within 0.5D of their intended refractive correction. More notably, in a series of 26 patients at one center that used the company’s ORA system, upgraded to VerifEye and combined with a femtosecond laser,  “LASIK-like” results were achieved. Specifically, 92% of the patients were within 0.5D of their intended correction, which is considerably higher than with a manual cataract removal without aberrrometry.

Data gathered and presented at various cataract surgery meetings in the recent past by Warren Hill, MD, a surgeon at East Valley Ophthalmology (Mesa, Arizona) illustrate how splendid those results are. According to Hill’s data, less than 1% of all cataract surgeons, doing the procedure manually, achieve a 90% rate of less than 0.5D to their targeted correction.  Further, only 20% of surgeons attain a 75% rate within 0.5D of the intended correction.

Privately-owned Clarity Medical Systems (Pleasanton, California) is developing its proprietary HOLOS IntraOp wavefront aberrometry system for cataract surgery. HOLOS, which has been endorsed by several prominent ophthalmic surgeons, is in the advanced stages of development. CEO Keith Mullowney told MDD that commercial shipments are expected to commence in late-2013.

Mahdavi informed MDD that the combination of Intraoperative aberrrometry and FLACS is a potent new development in cataract surgery. He feels that the former will significantly enhance outcomes while FLACS will draw patients to a surgery center because consumers are awed by any laser-based procedure.

“The laser is the sizzle and Intraoperative aberrrometry is the steak,” he quipped.

2013 Ophthalmology Innovation Summit

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