Allergan Receives Complete Response Letter from FDA for Prior Approval Supplement for Restasis 0.05% Multi-Dose Preservative-Free bottle

FDA requested additional CMC information for the Multi-Dose Preservative-Free bottle.

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 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.