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Report

Taking the plunge into dry eye care

29/07/2019By Myles Hume
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Dry eye’s journey from obscurity to multi-billion dollar industry has led to an uptake of eyecare professionals making it their business to treat this long-ignored patient group. MYLES HUME finds out what it takes to establish a dry eye clinic.

For a disease that once struggled for legitimacy, the rapid evolution of dry eye care in Australia has been remarkable.

Now a well-established subspecialty, only a decade ago a general lack of clinical and public awareness kept dry eye on the periphery while a significant patient group suffered in silence.

Today, however, an expanding body of evidence leaves little doubt over dry eye’s validity as a genuine disease. Measures vary, but it is said to impact at least 344 million people globally. In Australia, one in five adults encounter dry eye in their lifetime, and it is no longer perceived as a condition confined to older patients.

Given the statistics, dry eye is a chronic condition that is reaching epidemic proportions and, if left untreated, has been proven to significantly erode quality of life. Its pervasiveness can be linked to several factors including better diagnostic and treatment capabilities, the environment, technology-dependant lifestyles, or a combination of the above.

Subsequently, dry eye’s newfound relevance has exposed a significant gap in the eyecare market. As such, Australia is now home to an increasing number of professionals and clinics that are making it their business.

Insight spoke to Australia’s foremost experts about the dry eye market, and what should be considered before opening up to this unique patient group.

Dry eye's arrival

According to University of Melbourne Department of Optometry and Vision Sciences senior lecturer Dr Laura Downie, several factors have converged to spark increased clinician interest in dry eye.

“This likely reflects that dry eye disease is highly prevalent – affecting about one in five adults – and a chronic eye condition that falls well within the scope of optometric therapeutic care,” she said.

“Over the past few years, there has also been increased global awareness about the importance of diagnosing and managing dry eye disease, particularly through the work of the Tear Film and Ocular surface Society (TFOS), and the publication of the International Dry Eye WorkShop II (DEWS II) reports in 2017.”

Many consider DEWS II as one of the most critical contributions to dry eye’s acceptance as a multifactorial disease. The report involved 150 international clinical and basic research experts, including Downie, who used an evidence-based approach to also reach a consensus on some of the main aspects of the disease, and develop recommendations for diagnosis, management and therapy.

“As with all areas of practice, it is imperative that the diagnosis and management of dry eye disease is evidence-based. It is thus essential that eyecare clinicians, particularly those who are considering establishing a clinic with a particular disease focus, are abreast with the best-available research evidence,” Downie said.

“The 2017 TFOS DEWS II reports provided a comprehensive synthesis of state-of-the-art in the dry eye field,” she said, adding that there are opportunities for upskilling through postgraduate programs such as the University of Melbourne’s Specialist Certificate in the Management of Anterior Eye Disease.

As well as a strengthening body of research, dry eye diagnostics and treatment has become a multibillion-dollar industry, helping fuel even greater interest and confidence. Increased competition continues to reduce the price of more sophisticated equipment and therapies, improving accessibility.

Downie said: “For example, over the past two years, there has been a 400% increase in the development pipeline for dry eye therapeutics.

“As such, we expect to see the availability of a range of new dry eye therapies over the next several years, particularly those targeted to the dry eye subtypes such as aqueous-deficient and evaporative dry eye.”

Given the ever-expanding body of research, a suite of new treatments and an increasing patient cohort, the market conditions may have never been better for diversification into the dry eye arena.

'The learning curve is steep'

For optometrists, particularly independents, offering diagnosis and all-inclusive treatment program for dry eye could be an effective way add value to a practice. However, dry eye is notoriously time-intensive and can easily evolve into a costly exercise.

Because of this, according to established dry eye care practitioners, serious consideration must be given to the extent at which dry eye is incorporated into a practice, as well as the desired level of care. These factors, in turn, can help determine the level of financial investment to ensure dry eye services are viable.



"For example, over the past two years, there has been a 400% increase in the development pipeline for dry eye therapeutics"
Laura Downie, University of Melbourne

On recommending the best method of entry into dry eye care, established providers offered varied opinions. Some advised an ‘all or nothing’ approach, while others believed a gradual introduction is just as feasible.

Dr Jim Kokkinakis, of The Eye Practice in Sydney, provides a stark reality for professionals considering the establishment of a dry eye clinic.

“In my opinion it is important that you are either all in or not. This means providing all options. The reason for this is simple. There is no panacea. The arsenal you need is extensive,” he said.

Kokkinakis is considered one of Australia’s leaders in dry eye care. Operating a clinic that primarily specialises in complex contact lenses and spectacle prescriptions, seven years ago he decided to sharpen his dry eye expertise.

At his practice, Kokkinakis said a typical dry eye diagnostic consultation could take up to two hours. Among other things, this involves the use of the Lipiview imaging tool (meibum and blinking), meibography, non-invasive tear break up and aqueous volume.

“We have also just started to implement a new technology that is not available generally yet that is an infrared scan of the mucous layer. This is something that eye practitioners have ignored as there was no simple way of assessing this,” he said.

This is then followed by a customised treatment plan, which, in more severe cases, could result in the use of more sophisticated procedural-based treatments such as the LipiFlow thermal pulsation system, intense pulsed light (IPL) therapy and the MiBoFlo device to treat meibomian gland dysfunction.

“The learning curve is steep and there is not much change from $200,000. Leasing this over four years with no residual will be around $4,500 per month. You will also need extra room and a trained staff member - about a day a week of wages. Once you factor this in you are up to about $6,000 per month before you have made one cent.”

Kokkinakis added: “Specialty in anything involves a huge investment in professional development time and slowly accumulating enough clinical exposure to ocular surface disease to be able to accurately recognise the different contributors. Clinical exposure is critical as ‘one patient’s medicine can be another’s poison’.”

However, Mr Willy Gunawan, of Melbourne’s Collins St Optometrists, believes significant investments may not be necessary in the immediate term.

Gunawan, who introduced dry eye care to his practice in 2010, said the 2017 DEWS II report now set out clear treatment protocols, including a referral pathway. This has meant other optometrists could help ease the burden that mild to moderate cases currently place on existing dry eye clinics.

“You actually don’t need fancy machines. I didn’t have them when I started out. Everyone has access to slit lamps, flourescine and lissamine green stains. The DEWS II report also mentions you need to measure the tear osmolarity, which can also be done with inexpensive equipment that costs $1000-2000,” he said.

“You just start by listening. If the first few steps don’t work in accordance with DEWS II, you can then tell the patient you are going to refer them on to someone who has the equipment and tools to treat them at another level.”

Gunawan added: “We can’t get all dry eye patients treated through dry eye clinics. I think everyone needs to be more engaged with these patients. It’s not just the responsibility of dry eye clinics, it’s every optometrists’ responsibility.”

Ms Emma Furniss is a clinical optometrist at The Dry Eye Institute. Established in 2017, it is one of Australia’s few sole dry eye treatment centres.

She believes eyecare professionals should first invest and familiarise themselves with the basics in diagnostics treatment. She too identified osmolarity and lissamine green as a good starting point, as well as a Schirmer's test and a Meibomian Gland Evaluator.

“I love meibography as a tool for showing patients damage or the rate at which we should be undertaking treatment. It’s a really good piece of the puzzle. But this comes at a price,” she said.

“Basic treatments such as punctal plugs are a great idea for treating mild to moderate dry eye where appropriate. If you decide to invest in the more advanced diagnostic and treatment options, then yes, you will need enough space for these machines and extra chair time with the potential cost of someone to help take these measurements if you were to get busy enough.

“The technology ranges in price from a few thousand to tens of thousands but many of the basic diagnostic equipment is relatively affordable and accessible to the everyday practitioner.”

Patience with patients

Dr Nicholas Young
Dr Nicholas Young

While investment in diagnostics and treatments can vary, lengthy consultations and frustrated patients are guarantees at almost any level of dry eye care.

Practitioners report that consultations can range from 1-2 hours. Patients are often significantly affected, and many have become disillusioned after being passed from one provider to the next.

Dr Nicholas Young, of the Dry Eye Centre in Victoria, made dry eye a major component of his practice in 2013 and quickly discovered he was dealing with a unique cohort.

“Whilst efficiency in the consultation room is important, these are a special kind of patient – they need to be heard. A lot of these patients have been suffering for many years, and suffering during a time period in which this condition was commonly ignored, so generationally we haven’t got to a point where many of them have had a good experience with eyecare practitioners,” he said.

“So I think the absolute minimum level of care is giving patients an opportunity to discuss their condition in their own time, before quietly working through a history, examination and management plan. I think that is fundamental.”

Dr Jim Kokkinakis said attempting to diagnose and treat dry eyes as part of a normal comprehensive eye exam was typically only possible in mild cases.

“Having a dry eye clinic means you must be prepared for the train wrecks that will hit your doorstep. Your communication skills and your patience will be stretched to the limit,” he said.

“Dealing with moderate to severe disease is well beyond the scope of a standard eye test. Often 30 to 45 minutes needs to be devoted to the eye irritation, which presents a very significant patient flow and billing problem.”

Conversely, due to their ongoing discomfort, dry eye patients are also among the most compliant and willing. They often sought out other suffers and conduct their own research into the latest treatments.

Young added: “Due to their malaise, dry eye patients are often very motivated and tend to be a lot different to manage than those who may have conditions like glaucoma or macular disease, which generally don’t have physical pain associated with them.”

Profit or process?

Careful attention needs to be given to the motivation behind establishing a dry eye clinic. While some consider it a profitable segment of their business, for others the jury is out.

It can easily become an expensive undertaking; meaning costs are passed on to patients in most, if not all, cases. This dilemma also appears to be contributing to a belief that some eyecare providers are inappropriately marketing or over-servicing therapies instead of adopting an evidence-based approach to treatment.

Gunawan said his clinic infrequently used its most sophisticated instruments if he adhered to the DEWS II protocols.

“If you push for treatment, I’m sure you can make a lot of money, but you won’t be following protocols. I believe I need to be able to defend everything I do in my management plan, especially since we have now got an international consensus on how to manage these patients. You can’t go straight for the machines,” he said.

“I don't believe that seeing dry eye patients will be a particularly profitable venture, but it certainly will be and has been a very rewarding aspect of optometry, professionally.”

For Kokkinakis, the introduction of a dry eye service was a clinical decision, more than a financial one.

“I will definitely not retire because of my dry eye treatments,” he said.

“I have asked myself – if I could turn back the clock, knowing what I know now, would I bother creating a dry eye practice again, the answer would be yes. My practice is mainly anterior segment disorders so having a deep understanding of ocular surface disease has complemented our specialised niche.”

According to Dr Nicholas Young, of the Dry Eye Centre in Victoria, despite the ever-increasing emergence of specialty clinics, there are still only a select few making dry eye their world. Dry eye accounts for the majority of his business’ revenue and, to set his practice apart, he has invested heavily in order to treat even the most complex patients.

“Even some of the most internationally renowned dry eye practitioners can take up to two hours to evaluate a new patient. Medicare doesn't even come close to remunerating this duration of consultation. The practitioner needs to place a value on their time and charge accordingly. We also charge patients for all add-on procedures and treatments,” he said.

Young believed too many clinics were adopting a ”cookie cutter” approach to dry eye care. He said it was important for practitioners to responsibly market their dry eye services around a holistic approach to patient care, rather than the marketing material that accompanies popular device purchases.

“The latter not only fails to differentiate practices from each other, but also conveys a message to the public that dry eye treatment is as simple as pushing a button or flicking a switch, and unfortunately, in my experience, this notion couldn't be further from the truth,” he said.

“Clinics operate at different levels. I don't think we could claim to be a leading dry eye clinic without having such a unique approach and broad range of diagnostic and treatment options. That's mainly because many of our patients are referred to us from other health care providers, and might have already tried various other treatments.

“Having said that, optometrists can obtain a lot of valuable information using a basic slit lamp and should be encouraged to embrace dry eye as part of a standard consultation.”

He added: “For us, it’s about sitting down with these patients, giving them a level of commitment they may not have had before, and trying to understand their condition at a new level, which often involves areas of the body removed from the eyes, including physiological issues, allergies and gastrointestinal issues.”

Market movements in the dry eye category

All signs point to a prosperous future for the dry eye market. Pharmaceutical companies are generating billions from sales, and Australia’s eye lubricant market recorded $93.5 million in sales in the year to June, a 5.3% increase on the year previous.

An extensive range of experimental treatments are also in development and are expected to result in many new therapies, particularly targeted to subtypes such as aqueous-deficient and evaporative dry eye.

Allergan’s flagship dry eye drug Restasis (cyclosporine 0.05%) remains the largest earner in the global market, with sales of US$1.26 billion (AU$1.8 b) in 2018. Though despite its dominance, Restasis’ annual net revenue is decreasing. It also comes at a time when competing generic drugs are expected to enter the market.

Despite Restasis not being approved in Australia, local eyecare professionals have had cyclosporine produced in various concentrations (even up to 0.5%) via compounding chemists, but have offered mixed reviews on its performance.

An Allergan spokesperson told Insight the company had no plans to register or commercialise Restasis in Australia, however it would continue to provide access under the Therapeutic Goods Administration’s Special Access Scheme.

Xiidra (lifitegrast), which is said to be the first and only prescription treatment approved to treat both the signs and symptoms of dry eye by inhibiting inflammation, is also expected in Australia soon.

Novartis now owns the Xiidra – which has dry eye indications in the US, Canada and Australia – after purchasing it from Takeda Pharmaceuticals in a deal worth up to US$5.3 billion (AU$7.5 b). Xiidra generated US$400 million (AU$568 m) in revenue in 2018, with Novartis claiming it is “well positioned for blockbuster potential”.

It was listed on the Australian Register of Therapeutics Goods in January. A Novartis spokesperson said the company would be working with suppliers and regulators to provide access in Australia soon.

Locally, AFT Pharmaceuticals reported its Hylo-Forte eye drops have leapfrogged three positions to become Australia’s top selling eye lubricant by value.

According to the latest Australian pharmacy sales data to June, published by market research company IRi, Hylo-Forte generated more than $8.9 million in sales, $3.3 million more than the previous year.

This follows AFT’s 2018 launch of the non-aqueous, preservative-free eye lubricant NovaTears, which has itself moved into the top 40 selling eye lubricant products, generating $556,000. Within the latest quarter alone, NovaTears sales have exceeded 1700% compared with the same period in 2018.

“We are seeing the relative sales position for NovaTears being even further ahead than Hylo-Forte was at the same time of its life cycle. This bodes well for the future potential of this unique patented product – which is specifically designed for evaporative dry eye,” AFT Pharmaceuticals CEO Dr Hartley Atkinson said.

According to the same figures, Alcon Laboratories’ Systane Ultra Lubricating Eye Drop 10ml – last year’s category leader – and Systane Lubricating Eye Drop 15ml were the second and third highest earners respectively. They produced $8.8 million and $6.2 million in sales.

Overall, Atkinson said the European dry eye market had seen a 4% increase in units sold, and 8% rise in revenue.

“People do seem to be moving to higher value products, which you can see between the unit growth and the dollar growth. There seems to be a general trend towards preservative-free products; patients and customers are prepared to pay a little bit extra, which demonstrates they are mindful of the fact they are using these products long term.”

Lumenis has also released its sixth generation M22 Optima IPL, which is a drug and drop-free solution combining IPL and the company’s unique Optimal Pulse Technology. It is cleared for 20 different skin indications including inflammatory conditions such as Rosacea.

“US sales of the M22 grew by nearly 150% from 2017 to 2018 with the majority of systems purchased by optometry practices. This increase is expected to reach Australia with clinicians expanding treatment offering and profit centres,” a Lumenis spokesperson told Insight.

Good Optical Services last month released NuLids by NuSight Medical, which is said to offer fast doctor directed, at-home dry eye relief. The device consists of an oscillating Soft Tip design, which works by gently stimulating and rejuvenating the patient’s meibomian glands.

“The system has been in use in America for almost two years where patients are very pleased with the clinical relief of symptoms, easy one-minute per day treatment time, and the low cost of NuLids,” Good Optical Services general manager Mr Rick Good said.

Dry eye market leaders:

The escalating incidence of Dry Eye Disease has led to an expanding portfolio of diagnostic equipment and devices, as well as new treatment options for optometrists and patients. We provide an at-a-glance guide to the leading products in the market.

 

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