Amneal Pharmaceuticals announced that the FDA has approved the company’s cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation supplied in single-use vials. The newly approved product is the generic equivalent of dry eye disease treatment Restasis (Allergan, an AbbVie company, cyclosporine ophthalmic emulsion) 0.05%.

“Dry eye disease affects millions of adults in the United States and can significantly impact their quality of life,” said Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer – Affordable Medicines, at Amneal. “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.”

Cyclosporine ophthalmic emulsion 0.05% is a topical immunomodulator indicated to increase tear production in patients whose tear secretion is presumed to be suppressed due to ocular inflammation associated with dry eye syndrome. Clinical studies showed that increased tear production was not observed in patients concurrently using topical anti-inflammatory drugs or punctal plugs.

The most common adverse reaction reported during treatment with cyclosporine ophthalmic emulsion 0.05% was ocular burning. Patients and healthcare professionals are encouraged to review the full Prescribing Information for complete safety details.