New Generic for Dry Eye Rx

FDA approves first generic of Restasis (cyclosporine ophthalmic emulsion)

(RxWiki News) The US Food and Drug Administration (FDA) has approved a generic version of a medication for dry eye.

Restasis (cyclosporine ophthalmic emulsion) eye drops have been approved for nearly two decades, but now there's an FDA-approved generic version.

This drug is meant to increase production of tears in patients whose tear production is suppressed due to inflammation from keratoconjunctivitis sicca (dry eye).

“Restasis has been approved for use in the U.S. for nearly 20 years, but until today, there was no approved generic product of this drug that can help the millions of Americans who suffer from dry eyes,” said Dr. Sally Choe, director of the FDA's Office of Generic Drugs, in a press release.

Dry eye can lead to persistent eye discomfort, and Restasis has long been prescribed to help. It works by affecting the function of the immune system through anti-inflammatory properties. These effects typically lead to increased tear production that helps with the uncomfortable symptoms of dry eye.

A burning sensation in the eye was the most common side effect of this medication, according to the FDA. Other side effects included redness and dilation of the eyes, eye discharge, excessive eye watering, itchy skin and blurred vision.

If you are dealing with dry eye, talk to your health care provider about the best treatment for you.

Mylan Pharmaceuticals Inc. sponsored the generic version of Restasis that the FDA recently approved.

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Review Date: 
February 8, 2022