FDA Approves First Generic to Restasis Eye Drops

FDA approved the first generic version of Restasis (cyclosporine ophthalmic emulsion) 0.05% eye drops to increase tear production in patients whose tear production is suppressed due to dry eye.

The approval was granted to Mylan Pharmaceuticals.

Even without generic competitors, sales of Restasis, produced by Allergan, an AbbVie company, have fallen over the last three years, according to Market Scope. Sales plummeted 20 percent to $1.2 billion in 2020.

While Restasis has been approved in the US for nearly 20 years, there were previously no approved generic versions of the drug “that can help the millions of Americans who suffer from dry eyes,” said Sally Choe, Ph.D., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, in a statement.

“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,” Choe added.

The FDA has been conducting research to support the bioequivalence recommendations for cyclosporine ophthalmic emulsion since 2012, the agency said.

“In addition to informing the FDA’s draft product-specific guidance on cyclosporine ophthalmic emulsion 0.05%, the FDA’s research program has helped address complex issues on the analytical measurement and statistical assessment of a proposed generic product to Restasis,” FDA said.

The FDA has supported 16 research projects related to cyclosporine ophthalmic emulsion.

The most common side effect reported in the clinical trials for Restasis was ocular burning. Other reactions included conjunctival hyperemia (dilation and redness of blood vessels in the eye), discharge, epiphora (excessive watering of the eye), eye pain, foreign body sensation (the sensation of having something in your eye), pruritus (itchy skin), stinging and visual disturbance (most often blurring).