DEWS II algorithm gives new “Cliff’s Notes” for DED

The visual synopsis helps physicians better understand dry eye disease.

By Laura Periman, MD

The DEWS II classification algorithm — the summation of all the scientific, diagnostic and interventional advancements since the first DEWS report in 2007 — represents an efficient visual organizational synopsis for understanding DED.

Traditionally, physicians have been puzzled and frustrated by the sign/symptom disconnect. The helpful insights of this updated algorithm are fourfold: 1) understanding categories of sign/symptom disconnect; 2) organizing neurotrophic and neuropathic considerations as categories within the disconnect; 3) visually understanding hybrid disease with the mixed mechanism arrow. (Clinically, I find that this mixed mechanism arrow should be longer, covering roughly 85% of the field between aqueous deficient and evaporative dry eye); 4) establishment of the therapeutic philosophy of physiologic restoration back to homeostasis.

The DEWS II committee members’ job was to take all of the scientific, diagnostic and interventional advancements since the first DEWS report and organize them into an approachable algorithm that makes perfect sense to seasoned OSD doctors, while also being a clear road map to the new clinicians.

It’s not easy to distill the last decade’s vast expansion of ophthalmic knowledge into an approachable form. Thankfully, most ophthalmologists are visual learners. Show us a picture or slit lamp image, and we get it.

The DEWS II classification algorithm (see page 12) is an efficient visual organizational synopsis for understanding DED: a visual Cliff’s Notes. OM

A means to end corneal blindness

SightLife establishes a for-profit eye bank model to achieve a lofty goal.

By Jim Thomas, editorial director

Across the globe, eye banks can produce enough tissue for 150,000 corneal transplants, yet there are 10 million cornea-blind individuals worldwide, according to the Eye Bank Association of America. This “chasm” between supply and demand “can only be filled by innovation, which requires both size and scale,” says Monty Montoya, president and CEO of SightLife Surgical (SLS), a for-profit subsidiary of Seattle-based SightLife, the largest distributor of corneal tissue worldwide.

SightLife took a step toward achieving this size and scale last October when it launched SLS, a for-profit subsidiary. SLS, the first among eye banks, says it is determined to fund the innovation needed to meet the nonprofit parent company’s mission “of eliminating corneal blindness by 2040,” says Mr. Montoya. “This mission will drive all our innovation and investment.”

At press time, Sightlife announced it had appointed Claire Bonilla as CEO of the parent organization. Mr. Montoya, who has been SightLife’s CEO since 2003, will remain president and CEO of SightLife Surgical.

Since her appointment as chief global officer of SightLife in 2015, Ms. Bonilla has been credited with expanding the organization’s work to end corneal blindness. She has developed strategies to grow capacity (an average of 25% in more than 30 eye banks in developing countries), train more than 300 surgeons and ensure corneal transplants for more than 45,000 individuals.

“SightLife and Sightlife Surgical’s joint mission to end corneal blindness…will be best served by having separate CEOs to focus on their respective roles,” says Sightlife Board Chair Melody Summers.

To form SLS, SightLife secured $10 million in Series A financing from Flying L Partners, an investment firm led by William Link, PhD, Richard Lindstrom, MD, and Andy Corley. Under the new structure, SightLife, the nonprofit, will continue to facilitate eye donations, provide recovery services and screen donors. SLS will evaluate tissue, prepare tissue for transplants per surgeon requirements and distribute corneal tissue, surgical instruments and other products. In addition, SLS will provide access to reimbursement support and education, such as a DMEK wet lab, which it sponsored with the Cornea Society at ASCRS this year.

In terms of products, SLS offers:

• the EndoSerter corneal endothelium delivery instrument for DSEK
• a cannula for DMEK
• a donor trephine punch
• a recipient vacuum trephine
• autologous serum tears under an agreement with Imprimis Pharmaceuticals (available nationwide by year’s end)

SLS expects to launch one or two more products by the end of 2017, says Mr. Montoya.

SLS plans to develop additional offerings, which would be made available through the subsidiary as a one-stop-shop, says Mr. Montoya. “We are focused on getting surgeons access to equipment,” he says. For some products, such as the autologous serum tears, the company acts as a distributor. For others, including the EndoSerter, SLS takes the product through FDA approval, manufacturing, marketing and distribution.

In May, SLS announced plans to bring injectable endothelial cell therapy processing capabilities to the United States through a partnership with Shigeru Kinoshita, MD, PhD, of the Prefectural University of Medicine, Kyoto, Japan. The therapy, which SLS plans to bring to a worldwide market, is comprised from cultured human eye endothelial cells that are injected into the anterior chamber of a patient’s eye. The therapy could eliminate the need for corneal transplant surgery in many patients — a benefit for developing countries where the demand for corneal transplants exceeds available donor tissue.

In recent clinical trials in Japan, more than 30 patients treated with the therapy showed “great visual results with no infections or rejections and minimal postop care required,” says Dr. Kinoshita. SLS expects to conduct U.S. clinical trials using the generated cells in the coming years, according to a company news release.

Mr. Montoya understands that SightLife and SightLife Surgical’s unique approach will be met with skepticism from critics. “Our approach is disruptive compared with the way eye banking is done today,” says Mr. Montoya. “But our mission requires us to be respectfully disruptive to better serve surgeons, their patients and the 10 million corneal blind worldwide.” OM

An ophthalmologist’s guide to private equity

The should-you and how-to.

By René Luthe, senior editor

When done correctly, say physicians who should know, selling your practice to a private equity (PE) firm is a sound and professionally satisfying business move. At the OCTANe Ophthalmology Technology Summit this summer, veterans of PE buy-outs of eye-care practices offered advice on getting it right. In short: Take your time, do your homework, know your motivation and heed your partners.

Finding the right PE partner is crucial for a successful relationship, so the practice should give itself plenty of time. “We spent 18 months looking for the right type of partnership because we wanted a like-minded culture,” said Richard Lindstrom, MD, a founding physician at Minnesota Eye Consultants. He and his partners considered hospitals, ACOs and a merger/acquisition strategy to create a large “super-group.”

Once they decided on the PE route, they spoke with several firms. Minnesota Eye chose Waud Capital Partner, which then formed Unifeye Vision Partners as its ophthalmic practice acquisition portfolio firm, according to a press release.

Bruce Katzen, MD, agreed that practice partners must be on the same page motivation-wise. Katzen Eye Group shopped 18 PE firms before signing with Varsity Healthcare in 2014. He said it is of paramount importance to find a firm that understands the eye-care business.

As for how a practice can find that happy partnership, Bruce Maller, president of BSM Consulting, cautioned that practice owners must agree on why they want PE. Problems often arise, he said, when partners do it for reasons other than growth.

Another crucial piece of advice: “Spend money on a good attorney” to guide you through the process, he said. “This is an opportunity for growth,” said Dr. Katzen. Perform due diligence.

Why even consider the private equity route? According to Mark Rosenberg, ophthalmologists develop excellent businesses. But private equity firms are “pros” at investing, and more. It’s not just about money, but operational efficiencies as well, he added.

Mr. Rosenberg, CEO of Barnet Dulaney Perkins (BDP) Eye Center in Arizona should know. Earlier this year, the PE firm H.I.G. Capital invested in BDP and another Arizona-based practice, Southwestern Eye. Mr. Rosenberg will assume responsibility as CEO for both groups of practices.

Sami Abbasi, CEO and president, Unifeye Vision Partners, divulged his acid test for knowing if a practice has chosen the right PE partner. “I call it the steak dinner test. Do you believe you can resolve issues over a steak dinner? If so, you have the basis for a good relationship.”

As for how “big” PE will become in the ophthalmic market, Mr. Maller said he thought it would be large enough to disrupt the traditional device and pharmaceutical sales channels.

“How will your sales people talk to management of PE-backed practices?” he asked. OM

SMILE research roundup

Studies allow insights into long-term efficacy, corneal thickness impact on OBL and effect on collagen stress.

By OM staff

SMall Incision Lenticule Extraction (SMILE) is the latest technique to correct myopia and astigmatism. Surgeons perform the procedure with the Visumax femtosecond laser (Carl Zeiss Meditec).

Here are some of the most recently published studies on this technique. They examine safety and effectiveness, the impact of central corneal thickness and how it compares to flap-based procedures.

A SOLUTION FOR THE HIGHLY MYOPIC

To determine this procedure’s long-term effectiveness, particularly in highly myopic patients, Burazovitch et al. looked at results of a four-year study of 298 patients (496 eyes).¹ Before undergoing the SMILE procedure, patients were classified into either the highly myopic group refraction measured in spherical equivalent (RMSE)>-6 D (70 patients/140 eyes, 52 of whom were women) or the control group, whose RMSE was < -6 D. Data were collected from March 2012 to July 2016 at four follow-up points: immediately following the procedure, after three months, after one year and after four years.

In both groups, patients’ UCVA were better after the fourth year than immediately after the procedure, and 87% of operated-upon eyes in the highly myopic group were within 0.5 D of the target. Also, the groups’ refractive stability tended to converge over four years.

Researchers also looked at SMILE’s safety. Index of safety (SI) was identical among the two groups at the four follow-up tests; however, the highly myopic group attained SI stability after three months, while the control group attained SI stability after one month. Researchers concluded that SMILE produces stable, safe, effective and predictable results when treating high myopia.

BIOMECHANICAL IMPACT

A study authored by Seven et al. compared the biomechanical impact of flapless and flap-based procedures.² This small study concluded that intrastromal flapless procedures had less impact on anterior stromal collagen mechanics and resulted in lower stromal bed displacements and stresses compared to flap-based procedures. The study did note, though, that biomechanical impact varied widely between individual patients, reinforcing the need for individualized assessment of ectasia risk.

Tomographic data were taken from 10 eyes of five patients who were undergoing femtosecond laser refractive lenticule extraction for myopic astigmatism. Each patient underwent the SMILE procedure in one eye and flap-based femtosecond lenticule extraction in the other. Computational models were made from these data.

Case-specific treatment settings were incorporated into the analysis; surgically induced change in fiber stiffness within each flap was determined by minimization of the error between the simulated and actual six-month topographic outcomes.

The flap-based procedures produced a 49% greater mean reduction in effective stromal collagen fiber stiffness within the flap region than contralateral SMILE cases. Lower stresses and deformations were observed within the residual stromal bed in SMILE cases than in flap-based cases; stromal bed displacements and stresses were more affected by a loading increase in flap-based eyes than flapless eyes.

SMILE AND OPAQUE BUBBLE LAYER

A study found evidence that opaque bubble layer (OBL) formation during SMILE surgery is more likely in eyes with thicker corneas. While this may interfere with the surgical procedure, the study finds it is unlikely to affect postoperative visual outcomes.³ Ma et al.’s paper analyzed the effects of central corneal thickness (CCT) and residual stromal thickness (RST) on the formation of OBL during SMILE surgery. To examine these effects, researchers studied preoperative, intraoperative and postoperative records of 345 eyes from the database of the Refractive Surgery Center of Tianjin Eye Hospital. The records were from patients who had undergone SMILE surgery and then were followed for six months.

Of the 345 eyes, 22 developed various degrees of OBL during the femtosecond laser scanning phase of the SMILE surgery. The study found, after adjusting for age, sex and refractive errors, that there was a significant relationship between CCT and RST and OBL formation (OR 1.04; 95% CI 1.02-1.06; OR 1.03; 95% CI 1.02-1.05, respectively, P<.001). Smooth curve fitting displayed an increased risk of OBL in the presence of an increased CCT or RST. Visual outcomes were comparable between the two groups at three months and six months postoperatively. OM

REFERENCES

1. Burazovitch J, Naguzeswski D, Beuste T, Guillard M. Predictability of SMILE over four years in high myopes. J Fr Ophtalmol. 2017 Jun;40(6):e201-e209.
2. Seven I, Vahdati A, Pedersen IB et al. Contralateral eye comparison of SMILE and flap-based corneal refractive surgery: computational analysis of biomechanical impact. J Refract Surg. 2017;33:444-453.
3. Ma J, Wang Y, Li L, Zhang J. Corneal thickness, residual stromal thickness, and its effect on opaque bubble layer in small-incision lenticule extraction. Int Ophthalmol. 2017; doi: 10.1007/s10792-017-0692-2. [Epub ahead of print]