Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Allergan has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its Prior Approval Supplement (PAS) for RESTASIS (Cyclosporine Ophthalmic Emulsion) 0.05%, Multi-Dose Preservative-Free (MDPF) presentation.
Subscribe to our email newsletter
The FDA requested additional CMC information for the Multi-Dose Preservative-Free (MDPF) bottle, a first of its kind container with patented uni-directional valve and air filter technology.
Allergan is compiling the data requested and will respond to the FDA in a timely manner. In the absence of additional data requests from the FDA, Allergan does not anticipate a significant impact to previously communicated timelines of the potential approval of the MDPF bottle.
RESTASIS, approved by the U.S. Food and Drug Administration 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
Chronic Dry Eye is caused by reduced tear production due to inflammation. 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. Without enough tears, the film protecting the eye can break down, creating dry spots on the cornea.
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.