FDA Approves Allergan Restasis Multidose for Chronic Dry Eye

Allergan has received approval from the FDA for Restasis Multidose (cyclosporine ophthalmic emulsion) 0.05% for the treatment of chronic dry eye. The product is designed to help patients create more of their own tears. This latest approval will have the same preservative-free formulation of Restasis, which was originally launched in 2003.

With Restasis Multidose, patients will have another option aside from the single-vial Restasis that has been on the market.

"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 eyedrops in a multi-dose bottle versus single-use vials," said Neda Shamie, MD, a cornea and cataract specialist, in a press release.

The adverse effects of the product include eye redness, discharge, watery eyes, eye pain, foreign body sensation, itching, stinging, and blurred vision. However, the most common side effect is a temporary burning sensation.

Restasis Multidose has a patented unidirectional valve and air filter technology that eliminates the need to use a preservative. The multidose bottle is composed of less plastic than single-use vials, and it will be available for the same price.

"Through our Open Science model, we drive to deliver advancements in highly engineered developments, such as the new multi-dose bottle,” said David Nicholson, Chief R&D Officer at Allergan, in a press release.

Restasis Multidose and Restasis have not been shown to increase tear production in patients using anti-inflammatory eyedrops or tear duct plugs.