Viatris Receives FDA Approval For Generic Restasis To Treat Dry Eye Disease

(RTTNews) - Viatris Inc. (VTRS) said that its subsidiary, Mylan Pharmaceuticals Inc., has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Cyclosporine Ophthalmic Emulsion 0.05%, the first generic version of Allergan's Restasis.

There are no remaining legal or regulatory barriers, and the company is launching immediately, Viatris said in a statement.

Cyclosporine Ophthalmic Emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, also known as dry eye.

Dry eye disease is a common condition that occurs when a patient's tears are unable to provide adequate lubrication for their eyes. Tears can be inadequate and unstable for many reasons, but the instability can lead to discomfort, inflammation and potential damage of the eye's surface.