Allergan has submitted a Prior Approval Supplement (PAS) for RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%, seeking approval of a Multi-Dose Preservative-Free (MDPF) presentation. 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.
"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," said David Nicholson, Executive Vice President and President Global Brands Research and Development, Allergan. "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.