Allergan plc announced that it has received approval from the US Food and Drug Administration (FDA) for Restasis Multidose (Cyclosporine Ophthalmic Emulsion) 0.05%, a preservative-free, multi-dose bottle offering the same preservative-free formulation of Restasis since the launch in 2003. Restasis is the one and only prescription treatment FDA approved to help patients with a type of chronic dry eye make more of their own tears.
Restasis helps increase your eyes' natural ability to produce tears, which may be reduced by inflammation due to chronic dry eye. Restasis did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.
"Restasis Multidose will be an important addition to the Allergan family of dry eye products, as it will enable healthcare providers to offer an additional option for those patients who may prefer their eye drops in a multi-dose bottle versus single-use vials," said Neda Shamie, MD, fellowship-trained cornea and cataract specialist, of Advanced Vision Care, of Los Angeles, California.
Restasis Multidose is designed with a patented unidirectional valve and air filter technology that eliminates the need for a preservative. The new multi-dose bottle uses less plastic than a package of single-use vials and will be available for the same price.
"Restasis Multidose exemplifies Allergan's commitment to innovation and customer responsiveness," said David Nicholson, chief R&D officer at Allergan. "Through our Open Science model, we drive to deliver advancements in highly engineered developments, such as the new multi-dose bottle."
One type of 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.
Restasis and Restasis Multidose Ophthalmic Emulsion help increase your eyes' natural ability to produce tears, which may be reduced by inflammation due to chronic dry eye. Restasis and Restasis Multidose did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.
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.