Page 1 of 2
`
`FDA News Release
`
`FDA approves new medication for
`dry eye disease
`
`For Immediate Release
`
`July 12, 2016
`
`Release
`
`The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the
`treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first
`medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1)
`antagonist, approved by the FDA for dry eye disease.
`
`“Normal tear production is needed for clear vision and eye health,” said Edward Cox, M.D., director
`of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
`“This approval will provide a new treatment option for patients with dry eye disease.”
`
`Dry eye disease includes a group of conditions in which the eye does not produce an adequate
`volume of tears or when the tears are not of the correct consistency. The chance of experiencing
`dry eye increases with age, affecting approximately five percent of the adult population age 30-40
`and 10 to 15 percent of adults over age 65, and is more common among women. When severe
`and left untreated, this condition can lead to pain, ulcers or scars on the part of the eye called the
`cornea. Dry eye can make it more difficult to perform some activities, such as using a computer or
`reading for an extended period of time, and it can decrease tolerance for dry environments, such
`as the air inside an airplane.
`
`The safety and efficacy of Xiidra was assessed in over a thousand patients, in four separate,
`randomized, controlled studies. These studies included patients 19–97 years of age, of which the
`majority were female (76 percent). Patients were randomized equally to receive either Xiidra
`eyedrops or placebo eyedrops, which were used twice a day for twelve weeks. The studies found
`that groups treated with Xiidra demonstrated more improvement in both the signs and the
`symptoms of eye dryness than the groups treated with placebo.
`
`The most common side effects of Xiidra include eye irritation, discomfort or blurred vision and an
`unusual taste sensation (dysgeusia).
`
`Dry eye disease does not routinely occur in children. Safety and efficacy in pediatric patients below
`the age of 17 years has not been studied.
`
`https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510720.htm
`
`MYLAN - EXHIBIT 1077
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
`
`

`

`Page 2 of 2
`
`Xiidra is manufactured by Shire US Inc., of Lexington, Massachusetts.
`
`The FDA, an agency within the U.S. Department of Health and Human Services, protects the
`public health by assuring the safety, effectiveness, security of human and veterinary drugs,
`vaccines and other biological products for human use, and medical devices. The agency is also
`responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements,
`products that give off electronic radiation, and for regulating tobacco products.
`
`###
`
`Inquiries
`
`Media
`
`(cid:30) Theresa Eisenman (mailto:theresa.eisenman@fda.hhs.gov)
`(cid:167) 301-796-2969
`
`Consumers
`
`(cid:167) 888-INFO-FDA
`
`Follow FDA
`
`Follow @US_FDA (https://twitter.com/US_FDA)
`(/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm)
`Follow FDA (https://www.facebook.com/FDA)
`(/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm)
`Follow @FDAmedia (https://twitter.com/FDAMedia)
`(/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm)
`
`(cid:171) (cid:149) (cid:171)
`
`More in Press Announcements
`(/NewsEvents/Newsroom/PressAnnouncements/default.htm)
`
`2016 (/NewsEvents/Newsroom/PressAnnouncements/2016/default.htm)
`
`2015 (/NewsEvents/Newsroom/PressAnnouncements/2015/default.htm)
`
`https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510720.htm
`
`