A preservative-free Restasis equivalent to enter the U.S. dry eye market.
Dry eye specialists in the United States may soon have another tool in their treatment arsenal. Amneal Pharmaceuticals (New Jersey, USA) has announced that its cyclosporine ophthalmic emulsion 0.05% has received U.S. Food and Drug Administration (FDA) approval. This sterile, preservative-free formulation is a generic equivalent to Restasis (AbbVie; Illinois, USA), and with a launch expected in Q1 2026, it marks an expansion of Amneal’s portfolio in complex ophthalmic therapies and sterile manufacturing.
The product is indicated to increase tear production in patients with dry eye disease when tear production is reduced due to inflammation. Notably, increased tear production wasn’t observed in patients already using other topical anti-inflammatory treatments or punctal plugs, which gives clinicians clear expectations about where this generic might fit within a typical dry eye management plan.
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“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,” said Amneal Senior Vice President and Chief Scientific Officer Dr. Srinivas Kone in a news release. “Cyclosporine joins a series of recent approvals across inhalation, injectable and ophthalmic categories, underscoring Amneal’s strong execution in high-quality sterile manufacturing.”
A new generic option for dry eye
The dry eye space has expanded rapidly over the past decades, with more patients seeking relief from inflammation-driven symptoms. Cyclosporine remains one of the most established therapeutic approaches thanks to its ability to modulate inflammatory pathways that suppress natural tear production.
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Amneal’s formulation aims to meet clinical needs with familiarity: a proven active ingredient, delivery via a sterile preservative-free vial, and a safety profile aligned with the reference drug.
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The takeaway
Amneal’s FDA-approved cyclosporine ophthalmic emulsion 0.05% steps into a well-established but high-demand therapeutic space, bringing a welcome generic option for both dry eye patients and the clinicians who manage them.
For dry eye specialists, this new generic version doesn’t change the way cyclosporine works but does expand the number of patients who can realistically stay on therapy. And as the burden of dry eye disease continues to rise, having a few more arrows in the quiver—especially affordable ones—might make a meaningful difference in long-term outcomes.
Editor’s Note: This content is intended exclusively for healthcare professionals. It is not intended for the general public. Products or therapies discussed may not be registered or approved in all jurisdictions, including Singapore.