FDA Approves First Generic Version of Restasis for Dry Eye

Lucy Hicks

February 03, 2022

The US Food and Drug Administration (FDA) has approved the first generic of cyclosporine ophthalmic emulsion (Restasis) to treat keratoconjunctivitis sicca (dry eye). Restasis has been approved by the FDA since 2003 and works to help increase tear production by helping reduce dry-eye-associated inflammation.

The approval "reflects the FDA's continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts," said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research in a press release. "Supporting development and expanding opportunities to bring complex generic drugs to the market is a major focus of our efforts to help improve competition and help lower drug prices."

Dry eye occurs when the eye does not make enough quality tears to lubricate sufficiently and can cause stinging or burning in the eye, red eyes, and blurry vision. More than 16 million Americans have been diagnosed with dry eye disease, according to the 2017 National Health and Wellness Survey, though the number of people living with dry eye symptoms is estimated to be much higher.

In clinical trials, the most common side effect of Restasis was ocular burning. Other reported adverse effects included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance.

Beginning in 2012, the FDA began conducting research to aid the development of a bioequivalent for cyclosporine ophthalmic emulsion, and to date it has supported 16 related research projects. The generic approval announced February 2 was granted to Viatris Inc/Mylan Pharmaceuticals.

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