The Food and Drug Administration has approved the first generic version of AbbVie Inc.’s dry-eye drug Restasis, or cyclosporine ophthalmic emulsion (eye drops).
The generic cyclosporine ophthalmic emulsion will be available in 0.05% single-use vials, the FDA announced Tuesday.
Dry eyes affect approximately 7% of the U.S. population and nearly 19% percent of adults aged 75 years and older, according to data from a National Health and Wellness Survey. The condition can have many causes, but is often thought to be driven by inflammation, which in turn suppresses tear production. Restasis works to reduce inflammation and is a commonly prescribed drug for this purpose.
“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, Ph.D., of the FDA’s Center for Drug Evaluation and Research.
The drug has not been shown to be helpful in patients who take topical anti-inflammatory drugs or have had punctal plugs implanted (tiny devices placed in the tear ducts), two other treatments used to help alleviate the condition.
Notably, Restasis’s developers attempted to keep its patents from federal review by transferring them to a Native American tribe in 2017 in the hopes of keeping other companies from creating lower-cost versions of the drug, Reuters reported. The bid to do so was rejected by the Supreme Court in 2019.
