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The FDA of cyclosporine ophthalmic emulsion (Restasis) for dry eye, a condition that affects millions of Americans each year.

Cyclosporine ophthalmic emulsion is a commonly prescribed immunomodulator with anti-inflammatory effects that increases tear production presumed to be suppressed as a result of ocular inflammation associated with keratoconjunctivitis sicca (dry eye), and can be used in patients who did not respond to topical anti-inflammatory drugs or punctal plugs.

"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 Sally Choe, PhD, director of the Office of Generic Drugs in FDA's Center for Drug Evaluation and Research. "Today's 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."

Dry eye results when the eyes have insufficient tear production to stay wet or produce tears that have incorrect consistency. The most common symptom is ocular discomfort.

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

The FDA has supported 16 research projects related to cyclosporine ophthalmic emulsion to date. The agency granted the generic approval to Mylan/Viatris.

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