FDA Approves First Generic of Restasis

The FDA 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.”

Dry eye, also known as keratoconjunctivitis sicca, occurs when a person's eyes don't produce enough tears to keep them wet, or when the tears aren't the right consistency.

This disease, which affects millions of Americans each year, can cause discomfort in the eyes.

Cyclosporine ophthalmic emulsion is a regularly given immunomodulator (affects the functioning of the immune system) with anti-inflammatory effects that generally helps increase tear production in these patients.

Ocular burning was the most common side effect reported in Restasis clinical studies.

Conjunctival hyperemia (dilation and redness of blood vessels in the eye), discharge, epiphora (extreme watering of the eye), eye pain, foreign body sense (the sensation that something is in your eye), pruritus (itchy skin), stinging, and visual disruption were among the other effects (most often blurring).

Applicants must submit appropriate data and information to demonstrate that generic drug products meet the FDA’s rigorous approval standards, ensuring that generic drug products are safe, effective and meet the same high-quality standards as their brand name counterparts.

Complicated generics may be more challenging to develop due to factors such as complex active ingredient formulation or delivery mechanism. As a result, there is no generic competition for many complex medications.

Through the Generic Drug User Fee Amendments (GDUFA) program, the FDA has taken a multimodal strategy to encouraging the development of complicated generics.

Beginning in 2012, the FDA began undertaking research to support the creation of bioequivalence guidelines for cyclosporine ophthalmic emulsion as part of the GDUFA Science and Research Program.

In addition to informing the FDA’s draft product-specific guidance on cyclosporine ophthalmic emulsion 0.05%, the FDA’s research program has helped address complex issues on the analytical measurement and statistical assessment of a proposed generic product to Restasis.

To date, the FDA has supported 16 research projects related to cyclosporine ophthalmic emulsion.

The sponsor of the generic cyclosporine ophthalmic emulsion 0.05% single-use vials approved today is Mylan Pharmaceuticals Inc.