FDA Approves First Generic of Restasis

The U.S. Food and Drug Administration (FDA) has approved the first generic of Restasis© (cyclosporine ophthalmic emulsion) eye drops to increase tear production in people with chronic dry eye (CDE).¹

Why is a generic product good news?

Restasis has been approved for use in the United States for nearly 20 years, but there was no approved generic product of this drug. The approval of a generic version gives millions of people with CDE access to a lower-cost option to treat their symptoms.¹

The choice of a generic may also mean that more people will stick with their treatment. This is because research shows that reducing the costs of prescription drugs increases the likelihood someone will take the medicines prescribed by their doctor.²

Over the past 10 years, the FDA has supported work to find a generic for cyclosporine ophthalmic emulsion eye drops. While some people may think generics are less trustworthy than brand names, research shows the opposite. Using authorized generics leads to results comparable to those of brand-name products.^1,3

Drug makers must also submit data and information to prove that a generic drug meets the FDA's approval standards. This is to ensure that the generic drug is safe, effective, and meets the same high-quality standards as their brand-name counterparts.¹

What are the ingredients?

The active ingredient in the generic drug is cyclosporine. This is the same active ingredient in Restasis.⁴

How does the generic version of Restasis work?

The generic drug works to treat CDE by blocking a specific protein that is linked to inflammation of the ocular surface and tear glands. This decrease in inflammation restores the eyes' natural ability to produce tears. This is also how Restasis works.⁴

What are the possible side effects?

The most common side effect of Restasis and its generic version is a burning sensation of the eyes.⁴

Other less common side effects include:⁴

• Redness, itching, discharge, or a feeling of something stuck in or on the eye
• Eye pain
• Vision issues, most often blurred vision
• Eye swelling
• Rare cares of face, tongue, and throat swelling
• Eye injury from the vial tip during application

These are not all of the side effects of Restasis or its generic version. Talk to your doctor about what to expect when taking one of these products. You should also call your doctor if you have any changes that concern you when taking these drugs.

Things to know

Use the product immediately after opening a single-use vial. Discard any remaining product immediately after application.⁴

Because the generic version of Restasis is applied directly to the surface of the eyes, there is a risk of eye injury and contamination. Avoid touching the vial tip to your eye or other surfaces to avoid contamination.⁴

This drug should not be used when wearing contact lenses or if you have any signs of an eye infection. If you choose to wear contact lenses, they should be removed before using this drug.⁴

Before beginning treatment for chronic dry eye, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you take. This includes over-the-counter drugs.

For more information, read the full prescribing information of Restasis.