ONLINE EXCLUSIVE
Cornea
April 2022
by Liz Hillman
Editorial Co-Director
Restasis (cyclosporine ophthalmic emulsion) was developed by Allergan and approved by the U.S. FDA in 2003. Now, after nearly 2 decades since its approval as a brand name drug indicated for symptoms of dry eye, a generic version of Restasis has been approved. It was a “long time coming,” according to Henry Perry, MD.
In February 2022, Viatris announced that its subsidiary, Mylan Pharmaceuticals, received FDA approval for the generic cyclosporine ophthalmic emulsion. Viatris President Rajiv Malik said in a press release that this approval came after nearly a decade of work toward a generic option.
Dr. Perry said he became involved with the development of Restasis in 1995. The challenge with the drug originally was how to make an insoluble product—cyclosporine—at least partially soluble.
“What [Allergan] did is they added castor oil, glycerin, and polysorbate 80 to try to have the ability to present cyclosporine to the corneal epithelium. The excipient, or drug that carried cyclosporine, was the key to its development,” he said.
Allergan later went to court to try to prove that generics were not as good, said Dr. Perry, who testified in the suit.
“The generics were in a difficult situation because they couldn’t prove one way or the other without doing an enormous study, costing millions of dollars,” Dr. Perry said. “However, if they could prove a similar chemical product, they could get approved. That was very difficult. It took Allergan 5 years to get the excipient.”
It took the company producing the generic 4 years, Dr. Perry continued, adding that the excipients in the generic are 95% equal to Restasis.
As such, Dr. Perry said, “There is no reason to prescribe Restasis anymore, if there is a significant cost consideration.” Prescribers, he said, should not be concerned about the generic version not performing as well or as expected.
“Cyclosporine is a specific molecule, and the excipients are what carry it. It’s a different situation than many of the other brand medications where the actual chemical nature is not identical,” he said.
The benefit to the patient with the availability of a generic is cost.
“The price of Restasis has increased way over what it was originally. To me, there is no justification having the price as high as it is,” Dr. Perry said.
Dr. Perry reiterated that he thinks there is no significant difference between the generic and brand name Restasis drugs.
“It’s been proven to be equivalent by the FDA, and they gave the generics a very hard time. They did not have an easy road because it’s difficult to present cyclosporine to the epithelium in the suspension,” he said, adding later “all of the generics have been through rigorous tests.”
About the physician
Henry Perry, MD
Ophthalmic Consultants of Long Island
Rockville Centre, New York
Relevant disclosures
Perry: None
Contact
Perry: hankcornea@gmail.com
