FDA Approves Amneal Pharmaceuticals’ Cyclosporine Ophthalmic Emulsion 0.05%

The U.S. Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ cyclosporine ophthalmic emulsion 0.05%, a generic version of Restasis, which is a registered trademark of Allergan, an AbbVie company. This formulation is indicated to increase tear production in patients with dry eye disease, where tear production is believed to be reduced due to ocular inflammation. It is noted that increased tear production was not observed in patients currently using topical anti-inflammatory drugs or punctal plugs.

Generic Alternative for Dry Eye Disease

Cyclosporine ophthalmic emulsion 0.05% is a topical immunomodulator used to address tear deficiency in dry eye syndrome, a condition that affects a large portion of the adult population in the United States. This approval provides an alternative to existing therapies, contributing to broader access in ophthalmic care.

Commentary on Market Expansion

Srinivas Kone, PhD, Senior Vice President and Chief Scientific Officer at Amneal’s Affordable Medicines division, commented on the approval:

“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.”

Amneal has been expanding its offerings across several product categories, including inhalation, injectable, and ophthalmic medicines, supported by its sterile manufacturing capabilities.