The U.S. 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 keratoconjunctivitis sicca (commonly known as dry eye). Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
“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., 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.”
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 (affects the functioning of the immune system) with anti-inflammatory effects that generally helps to increase tear production in these patients.
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).
The sponsor of the generic cyclosporine ophthalmic emulsion 0.05% single-use vials approved today is Mylan Pharmaceuticals Inc.