Cequa Receives Approval to Treat Dry Eye
August 14, 2018 – The U.S. FDA has approved Cequa™ (cyclosporine ophthalmic solution) 0.09%, manufactured by Sun Pharmaceuticals, to increase tear production in patients who have keratoconjunctivitis sicca (dry eyes).
While there are a number of similar products already on the market, Cequa is available in a higher strength than competitors, with a preservative-free formula designed to increase absorption of the active ingredient, cyclosporine. Recommended dosing is one drop in each eye twice daily, 12 hours apart. The product is available in single-use vials only, dispensed in 60-count boxes. Each vial contains 0.25mL of medication, sufficient for one drop per eye.
The FDA originally approved cyclosporine, an immunosuppressant that helps to reduce or prevent inflammatory responses, in 1983. It is used in a variety of medications for multiple indications, including the treatment of several autoimmune disorders and prevention of organ transplant rejection. In 2002, Allergan’s Restasis® (cyclosporine 0.05%) became the first cyclosporine product to receive FDA approval to treat dry eye.