This study helped researchers learn if a medicine called SHP606 could help adults with dry eye disease have less severe symptoms.

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1 Summary of Clinical Study Results Thank you! Thank you to those people who took part in this clinical study. This study helped researchers learn if a medicine called SHP606 could help adults with dry eye disease have less severe symptoms. Why was this study done? Dry eye disease is a common disease, but the cause of this disease is not fully known. It affects women more than men. Dry eye disease happens when the eyes do not make enough tears, or the tears are not as good as normal. Either way the eyes do not stay moist. Doctors can prescribe eye drops to help dry eye disease. When dry eye disease is mild, over-the-counter eye drops called artificial tears may help improve symptoms. If dry eye disease is more severe, doctors can prescribe medicine to treat the inflammation that makes the eyes dry. Researchers wanted to learn if a medicine called SHP606, also known as lifitegrast, could help with dry eye symptoms. They also wanted to learn if SHP606 caused any medical problems, also known as side effects. When was this study done? This study started in November 2014 and ended in October Who took part in this study? Who could take part in this study? People could take part in this study if they: Had symptoms of dry eye disease in both eyes Had an eye examination that showed evidence of dry eye disease Used artificial tears for dry eye disease in the past 30 days Were 18 or older 1 of 6

2 People could not take part in this study if they: Had a condition that caused scarring in front of the eye, which led to dry eye disease Had certain other eye conditions Had certain other medical conditions Were taking certain medicines For more information on who could take part, please visit the websites listed on the last page of this summary. How many people were treated in this study? There were 711 people treated in this study. There were 174 men and 537 women. They were 18 to 93 years old. Everyone in this study was treated at clinics in the United States. What happened during the study? What did researchers want to know? Researchers wanted to learn if a medicine called SHP606 could help adults with dry eye disease have less severe symptoms. They did this by asking people in the study to measure how dry their eyes felt. They asked this before people in the study started treatment, during and after their treatment. Researchers also collected information on side effects of SHP606 during and after treatment. What treatments were studied? Researchers used 2 medicines in this study to learn about SHP606. They were: SHP606, given as an eye drop A placebo given as an eye drop The placebo looked like SHP606 eye drops but had no medicine in it. People in the study received either SHP606 or the placebo. They put 1 drop of study medicine in each eye, 2 times a day. 2 of 6

3 Everyone in the study was picked to take either SHP606 or the placebo. A computer picked people to take each medicine by chance, like pulling names out of a hat. This is also called randomization. The eye drops and the packaging for each medicine looked the same. No one who took the medicine knew what treatment they were taking. None of the researchers knew, either. This is called a double-blind study. About the same number of people took SHP606 and the placebo. How was the study done? A picture of how the study was done is shown below. Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Placebo eye drops taken Treatment with SHP606 Treatment with Placebo 2 week Before treatment Treatment (with week number) At the first study visit, or Visit 1, the doctor checked if people could take part in the study. If they could, they used the placebo eye drops in both eyes 2 times a day. They did this for 11 days. If they used the eye drops the way they were supposed to, they could start study treatment at the next visit. Researchers also showed people a line that measured eye dryness at the first study visit. One end of the line was marked 0. This meant no eye dryness. The other end was marked 100. This meant the most eye dryness possible. People marked the place on the line that matched how dry their eyes felt. Researchers gave people a score, or number, for each eye. A higher score meant the eyes felt more dry. The score could be anywhere from 0 up to 100. Here is an example of the line. Eye dryness of 6

4 At Visit 2, people in the study had tests before their treatment started. This included marking how dry their eyes felt on the same 0 to 100 scale, just like at Visit 1. Then, the computer picked people to take either SHP606 eye drops or the placebo eye drops. During treatment, people took their eye drops 2 times a day for 12 weeks. They visited the clinic after 2 weeks and again after 6 weeks. These were visits 3 and 4. They marked how dry their eyes felt at each of these visits, just like at Visit 1. Researchers asked people about their experience using the eye drops. The researchers also wrote down any side effects. At the last visit, or Visit 5, people marked how dry their eyes felt again, just like at Visit 1. It happened after 12 weeks of taking SHP606 or the placebo. People had now finished taking SHP606 or the placebo. Researchers asked again about people s experience using the eye drops. They also wrote down any side effects. Were there any side effects? Side effects are unwanted medical problems thought to be caused by a medicine or medical treatment. Not all of the people taking part in this study had side effects. A side effect is called serious when it is life threatening, causes lasting problems, or needs hospital care. No one who took part in this study had any serious side effects. Common side effects that were not considered serious are listed in the table below. In this study, common means the side effect happened in more than 16 people from any treatment group (SHP606 or the placebo). This is the same as 1 out of 20 people, or 5%. Common side effects, not considered serious Placebo (out of 354 people) SHP606 (out of 357 people) Irritation after eye drop taken Bad taste in mouth (Dysgeusia) Redness after taking eye drop 11 (3.1%) 65 (18.2%) 1 (0.3%) 46 (12.9%) 19 (5.4%) 45 (12.6%) No one who took part in the study died during the study. A total of 23 people left the study early due to side effects. For more information on side effects, please visit the websites listed on the last page of this summary. 4 of 6

5 What were the results? The table below shows the change in dry eye score after 12 weeks of taking SHP606 or the placebo. The dry eye score could be anywhere from 0 to 100. A higher score meant the eyes felt more dry. If the scores went down more after treatment, it meant the eyes were less dry after treatment. Average decrease in the dry eye score, after treatment Placebo (out of 354 people) SHP606 (out of 357 people) Average decrease in the dry eye score, after treatment Dry eye scores went down more for people taking SHP606 than for people taking the placebo. People who took SHP606 for 12 weeks had less severe symptoms after 12 weeks than people who took the placebo for 12 weeks. For more information on study results, please visit the websites listed on the last page of this summary. How has this study helped patients and researchers? Researchers look at the results of many studies to decide which medicines work well and are safe for patients. This summary gives the results for 711 adults with dry eye disease in a single study. Other studies might have more patients and might give different results. Findings from this study might be used to help patients or their eye care provider decide to try SHP606 for dry eye disease. Are there plans for further studies? Further clinical studies with SHP606 are planned. 5 of 6

6 Where can I find out more about this study? Title of this study: Protocol number: US study number: A Phase 3, Multicenter, Randomized, Doublemasked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects with Dry Eye Disease and History of Recent Artificial Tear Use (OPUS-3) SHP NCT Shire is the sponsor of this study. Shire has its headquarters in Lexington, Massachusetts in the United States. The phone number for general information is More information about this study can be found at: This summary of the study results was written with the help of an independent non-profit organization called CISCRP (The Center for Information and Study on Clinical Research Participation). 6 of 6