SILVER SPRING, Md.—The Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials (eye drops) to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with the condition commonly known as dry eye. The company that sponsored the application of the generic version approved earlier this week is Mylan Pharmaceuticals Inc., a division of the pharmaceutical company Viatris (VTRS.O), which was formed in 2020. AbbVie acquired Restasis with its acquisition of Allergan in 2020.

“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,” Sally Choe, PhD, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.
 
“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 branded drug Restasis is marketed by AbbVie’s Allergan business unit. AbbVie reported that sales of Restasis in the U.S. totaled $1.234 billion in 2021, and worldwide sales totaled $1.290 billion. The U.S. total represented a 4.1 percent sales increase on an operational basis over 2020.
 
For several years, Allergan tried to protect the patents on Restasis from a federal administrative court's review by transferring them to a Native American tribe in 2017. The bid was subsequently rejected by the Supreme Court in 2019, as VMAIL reported.
 
Keratoconjunctivitis sicca, or dry eye, happens when a person’s eyes don’t make enough tears to stay wet, or when the tears are not of the correct consistency. This condition, affecting millions of Americans each year, can make the eyes feel uncomfortable. Cyclosporine ophthalmic emulsion is a commonly prescribed immunomodulator with anti-inflammatory effects that generally helps to increase tear production in these patients.