FDA Approves Amneal Pharma's Generic Equivalent Of RESTASIS For Dry Eye Disease

(RTTNews) - Amneal Pharmaceuticals, Inc. (AMRX) on Tuesday announced that the U.S. Food and Drug Administration has approved its cyclosporine ophthalmic emulsion 0.05%, a sterile formulation supplied in single-use vials to treat dry eye disease.

The product is the generic equivalent of AbbVie's (ABBV) RESTASIS, chemically known as cyclosporine ophthalmic emulsion 0.05%.

Cyclosporine ophthalmic emulsion 0.05% is a topical immunomodulator indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with dry eye syndrome.

The product is expected to be launched in the first quarter of 2026.

"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, Chief Scientific Officer - Affordable Medicines.

Based on a 2013 study published in Science direct, Dry eye disease prevalence in the U.S. was estimated to be around 6.8% of adults or 16.4 million people diagnosed.

According to IQVIA, the U.S. annual sales for cyclosporine ophthalmic emulsion 0.05% in sterile, preservative-free single-use vials for the 12 months ended September 2025 were approximately $2.0 billion.

AMRX is currently trading at $12.29, down 0.16%.