Four Thousand LipiFlow® Treatments

Completed for Evaporative Dry Eye

DiseaseMorrisvile, N.C.,—June 14,

2012—TearScience®, a privately-held med ica l dev i ce company, today announced that 4,000 treatments of its LipiFlow® Thermal Pulsation System for

evaporative dry eye h a v e b e e n performed to date.  These treatments were per for med largely by the first 2 0 e y e c a r e practices to adopt

LipiFlow® as of February, 2012.  As of early June, TearScience has more than 40

eye care practices using the LipiFlow® system with multiple, new installations scheduled with a lead time of up to eight weeks. LipiFlow® uses heat and gentle pressure to unblock obstructed Meibomian glands  located in the eyelids during an in-office procedure.  The goal of unblocking the glands is to allow them to resume their natural production of lipids needed for a healthy tear film.

“Given our recent success with this new treatment, we are seeing LipiFlow® emerge as a new standard of care for evaporative dry eye patients,” said John A. Hovanesian, MD, of Harvard Eye Associates in Laguna Hills, California.  “How we approach dry eye is evolving because of LipiFlow®.  It has become a very positive advance for both patients and physicians alike.”

“In a randomized, controlled, multi-center clinical study, at four weeks after a single LipiFlow® treatment, 84 percent of patients experienced an improvement

in the number of Meibomian glands secreting lipids,” said Stephen Lane, MD, of Associated Eye Care in Stillwater, Minnesota.

The Evaporative Dry Eye Experts

TearScience NewsletterWINTER 2012 TREAT THE CAUSE ISSUE ONE

Refocusing on Evaporative Dry Eye

Are your eyes bothering you?

The keys to healthy eyesLipiFlow: Revolutionary treatment for dry eyes

Dry Eye-23 million sufferers in the U.S. costing $3.8 billion

annually.

VISIT OUR SITE

Patients Value LipiFlow®

The procedure, performed in a doctor’s office, is virtually painless and some patients consider it somewhat like a spa experience.

Evaporative Dry Eye

If your eyes feel scratchy and dry and eye drops or warm compresses never seem to provide enough help, you may have a chronic condition know as Evaporative Dry Eye.

Lack of Lubrication

Your discomfort may be a result of  Evaporative Dry Eye, which occurs when the water in tears evaporates faster than normal, due to an insufficient lipid (oil) layer on the tear film.

Revolutionary Technology

In a clinical study, 79% of patients reported improved

overall dry eye s y m p t o m s ( r a n g i n g f ro m

10% to 100% improvement) within four weeks of a single LipiFlow treatment.

Find Relief

Physicians equipped with the new LipiFlow technology are now located across the U.S. and Canada. They will e v a l u a t e y o u r symptoms, t e a r fi l m and gland function to determine

the underlying cause of your Dry Eye symptoms. It’s important to treat this chronic disease early, to avoid permanent loss of gland function, additional cell damage, or v isual deter iorat ion. Candidates for LipiFlow can complete treatment immediately.

Of the millions of dry eye sufferers in the U.S., approximately 86 percent have evaporative dry eye, which is caused by Meibomian gland dysfunction (MGD) and a lipid deficiency of the eye’s natural tear film.   In the U.S. alone, an estimated $3.8 billion is spent annually in treating dry eye.  At 38 percent of the total patient population, dry eye sufferers represent the larges t g roup of pat ients v i s i t ing ophthalmologists and a market opportunity exceeding $9 billion in the U.S.  Studies show that the average annual spending for moderate dry eye sufferers using wetting drops, prescription medications, and punctal occlusion to manage their dry eye symptoms is $2,959.

Te a r S c i e n c e ’ s 4 , 0 0 0 t h t r e a t m e n t milestone demonstrates how dry eye sufferers are embracing the value of LipiFlow®.  The treatment is currently a patient-pay procedure and on average, the LipiFlow® treatment ranges f rom $750-

$1,000 per eye in North America.

“My patients have experienced the benefits of LipiFlow®,” said Mujtaba Qazi, MD, director of clinical studies at Pepose Vision Institute in Chesterfield, Missouri.  “It is an effective treatment that addresses the root cause of evaporative dry eye, as chronically blocked tear glands are reopened and gland function is restored.  When patients add up the costs and hassles they incur for managing dry eye and the negative impact that this disease has on their lifestyle, they appreciate the true value of LipiFlow®.”

TearScience is investing millions of dollars in tooling and manufacturing

equipment with leading medical device contract manufacturers to ensure t h e ava i l a b i l i t y o f LipiFlow® Activators, the disposable eye piece u s e d d u r i n g t h e LipiFlow® treatment.

“We anticipate high demand for the treatment and have made this investment to support our current and future customers who adopt the TearScience® System as the new standard of care for their dry eye patients,” said Tim Willis, CEO and co-founder of TearScience.

TearScience’s system includes two medical devices, the LipiView® Ocular Sur face In te r f e rometer and the LipiFlow® Thermal Pulsation System, and a handheld tool for evaluating Meibomian gland function, called the Korb  Meibomian Gland Evaluator.  L i p i Vi e w ® c a p t u r e s , a r c h i v e s , manipulates, and stores detailed digital images of a dry eye patient’s tear film.  Evaporative dry eye occurs when Meibomian glands in the eyelids become obstructed and do not secrete the oily lipids needed to keep the water portion of tears from evaporating too quickly.

 1 Yu J, Asche CV, Fairchild CJ.  The economic burden of dry eye disease in the United States:   A decision tree analysis.  Cornea 2011; 30 (4):379-87.

 Media Contact:                                                          

Mary Hecht-Kissell

TearSciencemhkissell@tearscience.com(919) 459-4803

About TearScience, Inc.Headquartered in Morrisville, North Carolina, TearScience has pioneered devices that provide significant clinical improvement in the treatment of evaporative dry eye. Of the more than 100 million dry eye sufferers worldwide, approx im ate l y 86 pe rc en t h ave evaporative dry eye, which is caused by Meibomian Gland Dysfunction (MGD) and a lipid deficiency of the eye’s natural tear film. The Tear Film and Ocular Surface Society (TFOS) workshop, involving two years of work by 50 leading experts f rom around the world, concluded that MGD is an under-estimated condition and is very likely the most frequent cause of dry eye disease. Common symptoms of the disease include eye irritation, dryness, redness, tiredness, and visual disturbances. TearScience’s integrated, in-office system enables eye care professionals to

effectively address a root cause of evaporat ive dry eye, obs t ruc ted Meibomian glands. For additional information, visit www.tearscience.com.

C o n s i d e r a t i o n s f o r unsuccessful outcomes

Nerve damage and need to be reset from years of dysfunctional glands – lotomax tx x5 days qid. To quite and stabilize and reset the nerves, if the pt. remains symptomatic, pt. will need to be treated with a stronger steriod 3 days qid continue with lid scrubs and artifical tears - (lotomax is a low grade steroid that is not absorbed at the cellular level)

A.) systane balance (alcon) mineral oil based (has preservatives)

B.) optive advanced (allergan) cod liver oil based (has preservatives)

C.) retain mgd (occusoft) mineral based (no preservatives)

D.) soothe ointment (bausch and lomb)

-post regimen red eyes use b&l soothe or if you awake with red eyes soothe ointment

-patient probed more than 6 x (confirm prior to tx)

-mg drop-out

-poor candidate due to no oil secretion pre tx

-poor placement of adaptors – place adaptor nasally and down for best treatment nasal and medial

-adaptor did not heat to 42.5 degrees

-partial blinker – pt could have the best oils and not using the oils to coat the cornea which is using old or used oil

-to test for a complete blink:

a. lipiview test 2 blinks if good done if not verify by 3rd (30-50% of pts with mgd are partial blinkers)

blink protocol – close 1, 2 squeeze 1, 2 sec. q 15 min. for 30 days to retrain the brain for a complete blink

-aqueous deficient as well 30-40% will be aqueous and oil deficient

-seasonal allergy induced

-pre-existing conditions

The highest direct costs are incurred by patients who undergo punctal occlusion and use cyclosporine drops. These patients, regardless of symptom severity level, have direct costs of nearly $3,000 annually.

The highest indirect costs are incurred by those with the most severe symptoms. Nonetheless, the impact of dry eye disease on workplace productivity, even among the 40% of patients who are self-treating with artificial tears and nutri t ional supplements, i s more significant than previously thought.

Mild and moderate dry eye sufferers incurred a productivity loss valued at more than $12,000 annually, while severe dry eye patients lost about $18,000 in workplace productivity. The vast majority of lost productivity was due not to missed days of work but to impairment or r e d u c e d p r o d u c t i v i t y a t w o r k (“presenteeism”).

The direct and indirect costs of dry eye reaches $55.4 billion annually in the U.S. alone.

How Big a Burden is Dry Eye?

Dry eye may be costing your patients more than you think.

The first study to measure the cost of dry eye disease in the U.S. indicates that the economic burden of dry eye is significant—$3.84 billion in direct health care costs each year*. When the indirect costs of lost productivity are included, the societal burden of dry eye rises to $55.4 billion annually.

I n t h i s r e c e n t l y p u b l i s h e d , prevalence-based cost-of-illness analysis, the authors assess the cost of a typical stepwise treatment regimen of ocular l u b r i c a n t s f o l l o w e d by t o p i c a l cyclosporine and punctal plugs. The average annual direct cost per patient was $678 for patients with mild dry eye; $771 for moderate, and $1,267 for severe. In addition to the severity of symptoms, direct and total societal costs also vary based on whether or not the individual visited an eye care provider for treatment of dry eye and the treatments prescribed (Table 1).

The highest direct costs are incurred by patients who undergo punctal occlusion and use cyclosporine drops. These patients, regardless of symptom severity level, have direct costs of nearly $3,000 annually.

The highest indirect costs are incurred by those with the most severe symptoms. Nonetheless, the impact of dry eye disease on workplace productivity, even among the 40% of patients who are self-treating with artificial tears and nutri t ional supplements, i s more significant than previously thought.

Mild and moderate dry eye sufferers incurred a productivity loss valued at more than $12,000 annually, while severe dry eye patients lost about $18,000 in workplace productivity. The vast majority of lost productivity was due not to missed days of work but to impairment or r e d u c e d p r o d u c t i v i t y a t w o r k (“presenteeism”).

About the study

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This was an Internet-based survey of 2,171 employed U.S. adults with a diagnosis of Sjögren’s syndrome, dry eye disease, or an abnormal OSDI score (>12 out of 100).

More than 50% of respondents characterized their dry eye symptoms as mild. Among those who sought professional care, 31.4% had moderate symptoms, and 8.7% had severe symptoms.

Direct costs included ocular lubricants, nutritional supplements, cyclosporine, punctal plugs, and doctor visits. Indirect costs were based on days of lost work (absenteeism) and hours of lost productivity (presenteeism) due to dry eye symptoms, with costs based on an average wage of $15.95/hour. Detailed methods for calculating the cost, compliance, and usage of each type of resource are provided in the paper.

Results were compared to a validation model that used claims database inputs. Patient-reported resource usage in the study was similar to actual claims for punctal occlusion and cyclosporine prescriptions in a similar dry eye population.

Table 1: Direct and Total Costs of Dry Eye Disease per Person per Year, by Severity of Symptoms

MildMild ModerateModerate SevereSevere

Direct Total Direct Total Direct Total

No medical care $133 $3,538 $111 $8,692 $127 $18,292

Medical care

No prescription therapies

$452 $13,138 $452 $13,021 $688 $18,856

Plugs only $744 $13,430 $744 $13,313 $980 $19,148

Cyclosporine only $2,672 $15,357 $2,667 $15,236 $2,406 $20,574

Plugs + cyclosporine $2,964 $15,649 $2,959 $15,528 $2,698 $20,866

Adapted from: Yu J, Asche CV, Fairchild CJ. The economic burden of dry eye disease in the United States: A decision tree analysis. Cornea 2011;30(4):379-87.

The cost of treatment with the LipiFlow® Thermal Pulsation System for MGD is within the range of existing direct costs of managing dry eye especially for those sufferers using cyclosporine or multiple therapeutic approaches. LipiFlow has the potential to significantly reduce the total economic burden through improvement of symptoms that contribute to lost productivity.