FDA Approves Cyclosporine Ophthalmic Emulsion for Dry Eye


The FDA began conducting research to support the development of bioequivalence recommendations for cyclosporine ophthalmic emulsion in 2012.

The US Food and Drug Administration (FDA) has approved the first generic of cyclosporine ophthalmic emulsion (Restasis) 0.05% single-use vials to increase tear production in patients whose tear production is presumed to be suppressed from ocular inflammation associated with keratoconjunctivitis sicca.

Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

The condition, more commonly known as “dry eye”, has affected millions of Americans across the country. Patients affected with dry eye are often prescribed cyclosporine ophthalmic emulsion, which has anti-inflammatory effects that aid in increasing tear production in patients.

The FDA had started conducting research to support the development of bioequivalence recommendations for cyclosporine ophthalmic emulsion beginning in 2012 as part of the Generic Drug User Fee Amendments (GDUFA) Science and Research Program.

To date, the FDA supported 16 research projects related to cyclosporine ophthalmic emulsion.

The most common side effect reported in the clinical trials for the prescribed immunomodulator was ocular burning. Additional reactions included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging and visual disturbance such as blurring.

“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. 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.”

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