RESTASIS is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, a type of Chronic Dry Eye disease.
Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
If approved, RESTASIS in the MDPF bottle offers patients the same formula in a multi-dose system with patented uni-directional valve and air filter technology.
Allergan executive vice president and president of global brands research and development David Nicholson said: "With more than 60 years in developing innovative eye treatments, Allergan is committed to helping those suffering from Chronic Dry Eye disease and understand there is a need for innovative new delivery technologies for these patients.
"We are pleased with the submission of this PAS as it marks an important step forward for this delivery technology."
RESTASIS, approved by the U.S. Food and Drug Administration (FDA) in 2002, is the only eye drop that helps increase the eyes’ natural ability to produce tears, which may be reduced by inflammation due to Chronic Dry Eye disease. RESTASIS did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.
About Chronic Dry Eye
Dry Eye is a common condition that occurs when there are insufficient tears to lubricate and nourish the eye due to the eyes not producing enough tears. Tears help to keep eyes healthy and provide for clear vision. Dry eye is often a chronic disease that can be caused by advanced age, contact lens wear, certain medications, eye diseases, other medical conditions, or environmental factors. One type of Chronic Dry Eye is caused by reduced tear production due to inflammation. Without enough tears, the film protecting the eye can break down, creating dry spots on the cornea.i
About RESTASIS
RESTASIS helps increase the eyes’ natural ability to produce tears, which may be reduced by inflammation due to Chronic Dry Eye disease. RESTASIS did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.