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Allergan seeks approval for preservative-free Restasis

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Allergan announced it has submitted a Prior Approval Supplement for Restasis 0.05% to obtain marketing clearance for a multidose preservative-free formulation.

According to the company press release, if the new presentation of Restasis (cyclosporine ophthalmic emulsion) 0.05% is approved, it offers the same formula in a multidose system with patented unidirectional valve and air filter technology.

Restasis in its original form was approved by the FDA in 2002 and helps increase the eyes' natural ability to produce tears; however it did not increase tear production in patients using anti-inflammatory drops or punctum plugs, the company said.