Over the past decade, the treatment of ocular surface conditions such as dry eye and meibomian gland dysfunction (MGD) has evolved from “pats on the back” and warm compresses to innovative and effective tools and drugs, including Shire’s Xiidra, Allergan’s TrueTear (and, of course, Restasis), and Johnson & Johnson Vision Care’s (J&J VC) LipiFlow and LipiView systems.
So, what does the next decade hold?
Optometrists, ophthalmologists and company executives speaking at last week’s inaugural OIS Launch Event at SECO 2018 see continued upheaval in the ocular surface disease (OSD) sector as venture capitalists and ophthalmic companies continue to pour capital into developing new treatments. But the deeper change could come in the management of the disease, as optometrists have positioned themselves to be the primary caregivers for diagnosis and treatment.
Why Optometry’s Well Positioned
Eric Donnenfeld, MD, founding partner of Ophthalmic Consultants of Long Island, says most ophthalmologists don’t have the time to spend with patients to diagnose and treat dry eye disease, so the future of this field belongs to optometrists. “For dry eye to become the mainstay treatment that it should be, optometry has to take a leadership role,” Dr. Donnenfeld says. “But it’s not going to be given to you. It has to be taken.”
Several leading optometrists on the panel agree that their specialty sees an enormous opportunity ahead. Paul M. Karpecki, OD, associate professor at Kentucky College of Optometry at the University of Pikeville and director of cornea services at Kentucky Eye Institute, says ophthalmologists simply won’t have the bandwidth to treat dry eye, citing statistics showing that 431 new ophthalmologists will enter the field this year, while 451 will retire. “It is a case of taking it,” Karpecki says. “But it’s not a case of taking it from ophthalmologists.”
Representatives from Allergan, J&J VC and Shire delivered updates to the 50-plus optometrists in attendance on the status of their recently approved products to treat OSD, including dry eye.
Michelle Senchyna, PhD, executive director, clinical research for US eye care at Allergan, notes that TrueTear is the first effort to use neurostimulation in eye care. Patients using the device insert two prongs into the nasal cavity. It stimulates the nasolacrimal reflex to increase tear production.
TrueTear is having a long-term impact. In her presentation, Dr. Senchyna cited studies demonstrating that TrueTear produced more than twice the tears that sham or external stimulation did, and that the effect could last six months. “Patients now are taking accountability for their own care,” Dr. Senchyna says. Allergan acquired the TrueTear device in 2015 when it acquired startup Oculeve. The Food and Drug Administration (FDA) approved the device last year.
J&J VC’s LipiFlow and LipiView devices aim to enable optometrists and ophthalmologists to better diagnose MGD, in which blocked glands prevent necessary oils from mixing with tears.
“If you are in the business of managing ocular surface disease, you are in the business of managing meibomian gland function,” says Caroline A. Blackie, OD, PhD, medical director, dry eye, at J&J VC. Last year the company acquired TearScience, the maker of LipiView and LipiFlow systems that can identify and clear blocked glands.
Dr. Blackie notes that data demonstrated more than 80% of patients who received treatments continued to see improved tear production at 12 months. Close to 90% didn’t require a follow-up treatment over that period. Contact lens users who used the systems could also wear their lenses for up to four additional hours.
Shire Making Moves
Shire’s Xiidra, the first FDA-approved drop to treat both the signs and symptoms of dry eye, was the subject of a presentation by Robert Dempsey, group vice president and head of Shire’s global ophthalmics franchise. Dempsey says Shire is following up the successful US launch of Xiidra with a global rollout. Dempsey says the company hopes to obtain regulatory approval for Xiidra in 17 countries in the next 12 months.
Shire bet heavily on optometrists prescribing Xiidra in the US rollout. “As we go overseas, it’s a completely different market,” Dempsey says. He credits Allergan and J&J VC for the work they’ve done to build international dry eye markets.
Dempsey notes that Shire has built an early-stage pipeline that includes three candidates in ophthalmology:
- SHP640, a compound for treating infectious conjunctivitis that is in a Phase III trial.
- SHP659, a second dry eye agent entering Phase II trials.
- SHP639, a preclinical product targeting glaucoma.
OSD Sector Not ‘Overheated’ Yet
Founding OIS co-chair Emmett T. Cunningham Jr., MD, PhD, asked if the recent success in the OSD sector is leading to an overfunding of early stage ideas. Dr. Cunningham is also managing director of Clarus Funds and had success as an investor in SARcode Bioscience, the developer of the drops that eventually became Xiidra.
The increased attention is warranted, Dempsey says. “I don’t think it’s overheated,” he answers, adding that estimates of 20 early stage ventures targeting OSD “might be light.” Adds Dempsey, “With the ultimate approval of Xiidra, we saw an influx of early stage companies that were able to get venture capitalists to invest in their companies. We monitor every one of them, both in the US and globally.”
The treatment of OSD isn’t without its challenges. The most notable is the shortage of insurance coverage for new treatments.
Roughly 90% of private payers cover Shire’s Xiidra, but the company is still running up against some obstacles. For example, rival Allergan continues to hold exclusive coverage for Medicare Part D patients, a monopoly that Shire is challenging.
Josh Johnston, OD, FAAO, clinical director of Georgia Eye Partners in metro Atlanta, says existing reimbursement codes can make treating dry eye profitable for optometrists, but payers are not covering new therapeutic devices. Allergan will not pursue insurance coverage for TrueTear until 2020 or 2021. Says Matt Bolton, product director, dry eye marketing at Allergan, “We decided the best option was to pursue a cash model.”
Similarly, patients pay out of pocket for J&J VC’s LipiView and LipiFlow. The good news is that patients not only believe the treatments are worth the price, but they return for regular follow-up treatments.
W. Barry Lee, MD, of Eye Consultants of Atlanta, says his practice bought the first LipiFlow device in Georgia, and both the LipiFlow and LipiView get a lot of use in his practice. This allows him to identify patients who are only partially blinking their eyelids. He says many patients return – and pay – for annual treatments to keep ahead of the discomfort.
Whitney Hauser, OD, associate professor at Southern College of Optometry, says optometrists can succeed by implementing a LASIK-style business model, and that they shouldn’t apologize for the costs of treatment. “If it costs what it costs, then it costs what it costs,” she says. “I had a crown from my dentist, and it cost $1,200. The dentist never apologized.”
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