The first generic version of Restasis (cyclosporine ophthalmic emulsion) has been approved by the FDA, making it easier for patients suffering from ocular inflammation associated with keratoconjunctivitis sicca (“dry eye”) to increase their own production of tears.
Chronic dry eye disease, or chronic dry eye syndrome, occurs when there is a lack of production of real tears. On Feb. 2, the FDA announcement said that prior to the approval, millions of Americans who suffer from dry eyes had no option on the marketplace for a generic alternative to Restasis, a drug that was approved by the FDA nearly 20 years ago. Restasis is manufactured by Allergan, a subunit of AbbVie.
Sally Choe, Ph.D., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, stated, “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.”
Restasis works via anti-inflammatory pathways that increase tear production. In addition to not producing enough tears, sufferers of keratoconjunctivitis sicca do not have the correct consistency of fluid in their tears, which can make the condition very uncomfortable.
During clinical trials for Restasis, the most commonly reported side effect was ocular burning. Other side effects included dilation and redness of blood vessels in the eye (conjunctival hyperemia), discharge, excessive watering of the eye (epiphora), eye pain, the feeling of having something in your eye (foreign body sensation), itchy skin (pruritus), and stinging and visual disturbance, most often blurry vision.