The Food and Drug Administration (FDA) has approved the first generic version of Restasis, the cyclosporine ophthalmic emulsion eye drops. Cyclosporine ophthalmic emulsion increases tear production in patients who have ocular inflammation associated with keratoconjunctivitis sicca (commonly known as dry eye).
Nearly 16 million Americans have dry eye disease, according to the National Eye Institute of the National Institutes of Health. Dry eye occurs when the body doesn't produce sufficient tears or produces tears that are of poor quality, leading to inadequate lubrication of the eye. The lack of appropriate tearing leads to inflammation and damage of the eye's surface. Cyclosporine ophthalmic emulsion is an immunomodulator with antiinflammatory effects that promotes tear production.
Signs and symptoms of dry eye include
* a stinging, burning, or scratchy sensation in the eyes.
* stringy mucus in or around the eyes.
* sensitivity to light.
* eye redness.
* a sensation of having something in the eyes.
* difficulty wearing contact lenses.
* difficulty with nighttime driving.
* watery eyes, which is the body's response to the irritation of dry eyes.
* blurred vision or eye fatigue.
To receive generic drug approval, the manufacturer was required to submit data to the FDA showing that its generic drug product is safe, is effective, and meets the same high-quality standards as the brand-name counterpart. Generic Restasis is expected to be available in packs of 30 and 60 single-use vials, containing 0.5 mg of cyclosporine in every 1 mL vial, similar to the brand-name product.
Restasis can be expensive in the long term. According to http://ClinCalc.com, the average total cost of treatment per day is $18.14, or $6,621.10 per year. A generic form of the drug is expected to be less expensive, which will be important for many patients, especially if they don't have insurance that covers Restasis. As we went to press, the manufacturer Viatris/Mylan Pharmaceuticals has not posted the expected price.
For complete prescribing information for generic cyclosporine ophthalmic emulsion, go to http://www.accessdata.fda.gov/spl/data/da3fa070-b512-4568-871a-dc8d5a949d13/da3f.