FDA approves generic cyclosporine ophthalmic emulsion for DED

The FDA announced approval of the first generic version of Restasis (cyclosporine ophthalmic emulsion) 0.05% eye drops Thursday.


The FDA announced approval of the first generic version of cyclosporine ophthalmic emulsion 0.05% (Restasis; Allergan) eye drops Thursday.

The approval was also announced by Viatris Inc, as its subsidiary, Mylan Pharmaceuticals, recieved its Abbreviated New Drug Application (ANDA). With no remaining legal or regulatory barriers, the company will be launching immediately.

Restasis is a single-use vial designed to increase tear production in patients whose tear production is suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, better known as dry eye, according to an FDA news release.

While Restasis has been in approved in the United States for almost 20 years, there had not been an approved generic product of the drug for those suffering from dry eyes, according to Sally Choe, PhD, director of the Office of Generic Drugs in FDA’s Cener for Drug Evaluation and Research.

“(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 counterpartsm,” she said in a statement. “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.”

A common side effect reported in the Restasis clinical trials was ocular burning.
Other reactions included:

  • Conjunctival hyperemia
  • Discharge
  • Eye pain
  • Foreign body sensation
  • Pruitus
  • Stinging
  • Visual disturbances