“Survey results highlight the expanding patient demographics that many eye care professionals have been observing in their practices,” said Marguerite McDonald, MD, FACS, board-certified ophthalmologist, Ophthalmic Consultants of Long Island. “While age and female gender continue to be significant risk factors for dry eye disease, most ECPs believe that the rise of our multi-screen lifestyle has led to a noticeable shift, with more young adults presenting with dry eye symptoms than in years past. Importantly, the results also suggest that women over the age of 50, who are already known to be at increased risk for dry eye, may also be more at risk today due to our modern lifestyle. In today’s world, adults of various ages need to know what symptoms to look for and talk to an ECP right away if they notice these changes in their eyes.”

Dry eye disease is an inflammatory disease of the ocular surface that is often chronic and may be progressive. The disease is most commonly associated with dryness and overall eye discomfort, as well as stinging, burning, a gritty feeling or episodes of blurred vision.

Among ECPs the survey found:

• The vast majority say the use of modern technology contributes to dry eye symptoms (92%) and that dry eye disease is becoming more common because of today’s multi-screen lifestyle (89%)
• More than three-quarters (76%) report an increase in patients between the ages of 18-34 with dry eye symptoms compared with 10 years ago
• Nearly nine in 10 (87%) say that in today’s world, there is no one typical type of dry eye patient

According to adults with dry eye symptoms who participated in the survey:

• Screens including computers, TVs, hand-held electronics (e.g., smartphones, tablets, e-readers), and video games receive primary blame for causing their symptoms, with more than half (53%) feeling that screen-time is responsible for their dry eyes
• Fewer respondents attribute their symptoms to other factors like aging, lack of sleep, contact lens use, or environmental factors
• Most (79%) say they are more aware of “feeling their eyes” after viewing a screen and that using a screen is challenging as a result of their dry eyes (59%)

Still, on average, adults with dry eye symptoms spend eight hours daily in front of a screen, pointing to how difficult it may be to disconnect even when screen time is perceived to contribute to dry eye symptoms.

Condition May Affect Daily Activities and How People Feel
In addition to documenting how technology is putting more people at risk for dry eye, the survey results also reinforce that this condition can impact people beyond the physical signs and symptoms. Adults with dry eye symptoms say that those symptoms affect them in various ways throughout their day. Specifically, the survey found that:

• More than half (54%) say their dry eye symptoms impact their job/career or ability to work
• Most report that having dry eyes impacts their ability to spend time in front of a screen (75%), participate in hobbies (68%), perform daily activities (64%), and/or their physical appearance (56%)
• More than half (56%) say they know what activities are going to cause dry eyes and try to avoid them
• More than four in 10 (43%) say their dry eye symptoms often keep them from what they want to be doing
• Dry eye symptoms often cause annoyance (57%), fatigue (46%), and frustration (42%)

Complicating matters further, more than half of adults with dry eye symptoms (52%) believe that their symptoms are getting worse over time. Nearly seven in 10 (69%) feel like dry eye symptoms are just something they have to live with.

“Many people feel like they need to live with dry eye symptoms and may not realize the impact of dry eye on vision, comfort, and eye health,” said Kelly K. Nichols, O.D., MPH, Ph.D., FAAO, Dean of the University of Alabama at Birmingham School of Optometry. “In some cases dry eye disease may cause damage to the ocular surface. If symptoms are interfering with a person’s daily activities in any way, then they should seek the advice of an eye care professional.”

Difficulties with Diagnosis; Many Wish Dry Eye Conversation Started Sooner
Despite dry eye disease becoming more common, lack of awareness and other factors may be causing patients to be missed. According to the survey, eight in 10 ECPs believe dry eye disease is underdiagnosed.

And, while surveyed adults with dry eye symptoms rank sight as the sense that’s most important to them (with 64% reporting that they can’t live without the sense of sight, compared to 15% for taste and even less for other senses), most (55%) say that they did not pay much attention to their eye care until they started experiencing dry eye symptoms. Even then, they typically waited two years between symptom onset and seeking the advice of a healthcare provider. This may be because about half of adults with dry eye symptoms (49%) dismiss them as a normal part of aging and approximately one in three (32%) don’t understand that there is potential for long-term damage to their eyes. Still, nearly three in five adults with dry eye symptoms (57%) say they wish they had spoken to an eye care professional sooner, and about three in four ECPs (74%) wish their patients had asked about their dry eye symptoms earlier as well.

More About Dry Eye Disease
Nearly 30 million Americans experience symptoms consistent with Dry Eye Disease.^1,2 People who think they are experiencing possible dry eye symptoms are encouraged to talk to an eye doctor to request screening. Visit www.myeyelove.com to learn more about dry eye, including how to recognize symptoms, typical risk factors and useful tips on how to discuss symptoms with a doctor or eye care professional. Follow myeyelove on Facebook, Twitter, and YouTube for important updates on eye health.

About the Survey
The National Eye C.A.R.E. (Current Attitudes Related to Eye Health) Survey was conducted online within the United States by Harris Poll on behalf of Shire between July 6 and 27, 2015. The consumer arm of the survey included a total of 1,210 US adults ages 18+ who report dry eye symptoms (“adults with dry eye symptoms”), including 375 adults who have been diagnosed with dry eye disease (or chronic dry eye) by a healthcare professional (“patients”) and 835 adults who have not been diagnosed, but experience dry eye symptoms and have used artificial tears to relieve those symptoms within the past month. The professional arm of the survey included 1,015 US adults ages 18+ who are optometrists (n=502) or ophthalmologists (n=513) (“ECPs”). For complete research method, including weighting variables and subgroup sample sizes, please contact Clotilde Houzé, Director, Portfolio Communications, Shire, at [email protected].

Shire’s Commitment to Ophthalmics

In May 2014, Shire entered into ophthalmics, solidifying its commitment to growing in this emerging therapeutic area. Shire’s multi-faceted approach to discovery, development, and delivery in both rare diseases and specialty conditions includes our efforts to address unmet needs in eye care.

Shire’s ophthalmics business has been driven by a combination of strategic acquisitions and organic growth. Committed to growing its reputation as a leading biotech company, Shire is focused on continuing to expand its ophthalmics portfolio to include treatment options for rare diseases and those for anterior and posterior segment eye conditions. In just three years, acquisitions include Foresight Biotherapeutics, SARcode Bioscience, Premacure AB, and BIKAM Pharmaceuticals, which have helped bolster Shire’s early-, mid- and late-stage ophthalmics pipeline. The Company currently has an ophthalmics pipeline of investigational candidates in infectious conjunctivitis, autosomal dominant retinitis pigmentosa, and glaucoma.

For further information please contact:

NOTES TO EDITORS

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
www.shire.com

Forward-Looking Statements

Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:

• Shire’s products may not be a commercial success;
• increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire’s future revenues, financial condition and results of operations;
• Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
• the manufacture of Shire’s products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
• certain of Shire’s therapies involve lengthy and complex processes, which may prevent Shire from timely responding to market forces and effectively managing its production capacity;
• Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
• the actions of certain customers could affect Shire’s ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire’s revenues, financial conditions or results of operations;
• Shire’s products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
• adverse outcomes in legal matters, tax audits and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the combined company’s revenues, financial condition or results of operations;
• inability to successfully compete for highly qualified personnel from other companies and organizations;
• failure to achieve the strategic objectives with respect to Shire’s acquisition of NPS Pharmaceuticals, Inc., Dyax Corp. (“Dyax”) or Baxalta Inc. (“Baxalta”)may adversely affect Shire’s financial condition and results of operations;
• Shire’s growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
• a slowdown of global economic growth, or economic instability of countries in which Shire does business, as well as changes in foreign currency exchange rates and interest rates, that adversely impact the availability and cost of credit and customer purchasing and payment patterns, including the collectability of customer accounts receivable;
• failure of a marketed product to work effectively or if such a product is the cause of adverse side effects could result in damage to the Shire’s reputation, the withdrawal of the product and legal action against Shire;
• investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
• Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
• Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which may decrease its business flexibility and increase borrowing costs;
• difficulties in integrating Dyax or Baxalta into Shire may lead to the combined company not being able to realize the expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all; and

other risks and uncertainties detailed from time to time in Shire’s filings with the Securities and Exchange Commission, including those risks outlined in “ITEM 1A: Risk Factors” in Shire’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.

All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.

¹Paulsen AJ, Cruickshanks KJ, Fischer ME, et al. Dry eye in the Beaver Dam Offspring Study: prevalence, risk factors, and health-related quality of life. Am J Ophthalmol. 2014;157(4):799-806.

²Annual Estimates of the Resident Population for Selected Age Groups by Sex for the United States, States, Counties, and Puerto Rico Commonwealth and Municipios: April 1, 2010 to July 1, 2014. U.S. Census Bureau, Population Division. June 2015.

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