FDA approves Amneal Pharmaceuticals' cyclosporine ophthalmic emulsion 0.05%

The US FDA has approved Amneal Pharmaceuticals’ cyclosporine ophthalmic emulsion 0.05%, which is is the generic equivalent of RESTASIS 0.05%, a registered trademark of Allergan, an AbbVie company.

Cyclosporine ophthalmic emulsion 0.05% is a topical immunomodulator to increase tear production in patients whose tear production is thought to be reduced due to ocular inflammation associated with dry eye syndrome. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.¹

The FDA accepted for review the company’s Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01% at the end of September 2025.² An ANDA is a submission to the FDA that seeks approval to market a generic version of an already-approved brand-name drug, relying on the already approved medicine to reduce the need for extensive preclinical and clinical human trials.

Srinivas Kone, PhD, senior vice president and chief scientific officer at Affordable Medicines commented on the approval, saying, “Dry eye disease affects millions of adults in the United States and can significantly impact their quality of life. We are proud to bring another difficult-to-manufacture ophthalmic product to market, reinforcing Amneal’s strong execution in complex formulations and our expanding leadership in ophthalmology within the Affordable Medicines segment. Cyclosporine joins a series of recent approvals across inhalation, injectable, and ophthalmic categories, underscoring Amneal’s strong execution in high-quality sterile manufacturing.”

The Affordable Medicines segment of Amneal mentioned by Kone expands across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars.

In June 2025, Amneal also announced that the FDA had approved prednisolone acetate ophthalmic suspension, a sterile, topical anti-inflammatory agent for ophthalmic use that is indicated for treating steroid-responsive ocular inflammation, referencing Pred Forte.³

References

1. Amneal Announces U.S. FDA Approval of Cyclosporine Ophthalmic Emulsion 0.05%. Published December 2, 2025. Accessed December 2, 2025. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Announces-U-S--FDA-Approval-of-Cyclosporine-Ophthalmic-Emulsion-0-05/default.aspx

2. Harp MD. FDA approves abbreviated new drug application from Amneal Pharmaceuticals for bimatoprost ophthalmic solution 0.01%. Published September 23, 2025. Accessed December 2, 2025. https://www.ophthalmologytimes.com/view/fda-approves-abbreviated-new-drug-application-from-amneal-pharmaceuticals-for-bimatoprost-ophthalmic-solution-0-01-

3. Harp MD. FDA approves prednisolone acetate ophthalmic suspension for treating steroid-responsive ocular inflammation. Published June 12, 2025. Accessed December 2, 2025. https://www.ophthalmologytimes.com/view/fda-approves-prednisolone-acetate-ophthalmic-suspension-for-treating-steroid-responsive-ocular-inflammation