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.
As said in Allergan’s press release, 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.
Restasis. Image (Allergan)
If approved, Allergan says, 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, Allergan says, and adds that RESTASIS did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.
About Chronic Dry Eye
Explaining Dry Eye, Allergan notes that 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.
Important Safety Information
Do not use RESTASIS if you are allergic to any of the ingredients. To help avoid eye injury and contamination, do not touch the vial tip to your eye or other surfaces. RESTASIS should not be used while wearing contact lenses. If contact lenses are worn, they should be removed prior to use of RESTASIS and may be reinserted after 15 minutes. The most common side effect is a temporary burning sensation. Other side effects include eye redness, discharge, watery eyes, eye pain, foreign body sensation, itching, stinging, and blurred vision.