On Wednesday, the U.S. Food and Drug Administration (FDA) announced the approval of the first generic version of Restasis (cyclosporine), an ophthalmic solution for patients with dry eyes.
The medicine increases tear production in those who have less production due to eye inflammation associated with dry eye, a condition called keratoconjunctivitis sicca.
Dr. Sally Choe, Director of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research at FDA, said. “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.”
“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,” she added. “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.”
Each year, dry eye affects millions of Americans. It happens when your eyes fail to make enough tears to stay wet.
Cyclosporine ophthalmic emulsion is one of the commonly prescribed immunomodulators with anti-inflammatory effects, which has shown great efficacy in increasing tear production.
Some of the common side effects of Generic Restasis include ocular burning, dilation and redness of blood vessels in the eye, discharge, excessive watering of the eye, eye pain, itchy skin around the eyes, and mild visual disturbance.
Mylan, a global generic and specialty pharmaceuticals company, has received the FDA approval for its generic version of Restasis ophthalmic emulsion 0.05%.
The agency has been conducting research to support the development of generic cyclosporine ophthalmic emulsion.
The FDA’s research program has been helping address complex issues on the analytical measurement and statistical assessment of a proposed generic product to Restasis, according to the U.S. drug regulatory body.
So far, the agency has supported 16 research projects associated with generic cyclosporine ophthalmic emulsion.
Under the Drug Competition Action Plan, the FDA addresses the challenges related to developing complex generic drugs and helps promote more generic competition. The agency is aiming to promote patient access to more affordable generic medicines.
