Amneal Announces U.S. FDA Approval of Cyclosporine Ophthalmic Emulsion 0.05%

Rhea-AI Summary

Amneal (NASDAQ: AMRX) announced U.S. FDA approval of its cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation supplied in single-use vials and approved as the generic equivalent of RESTASIS.

The company says the product will launch in Q1 2026. The approval highlights Amneal’s sterile manufacturing capabilities and expansion in complex ophthalmic therapies. IQVIA U.S. annual sales for this product format were ~$2.0 billion for the 12 months ended September 2025. The drug is indicated to increase tear production for dry eye due to ocular inflammation; the most common adverse reaction was ocular burning.

Positive

• FDA approval secured for cyclosporine ophthalmic emulsion 0.05%
• Launch planned Q1 2026 for U.S. market entry
• $2.0B IQVIA U.S. annual sales for this product format (12 months ended Sep 2025)
• Sterile, preservative-free single-use vials align with preferred ophthalmic delivery

Negative

• Most common adverse reaction: ocular burning
• Increased tear production not observed in patients using topical anti-inflammatory drugs or punctal plugs

Insights

Regulatory & Commercial Ophthalmology Analyst

FDA approval of Amneal's sterile, single-use 0.05% cyclosporine positions the company to enter a ~$2.0 billion market with a planned Q1 2026 launch.

Amneal now holds approval for a preservative-free, sterile, single-use vial formulation that FDA found bioequivalent to RESTASIS®. The approval confirms regulatory acceptance of Amneal's sterile manufacturing for complex ophthalmics and clears the path for a commercial launch in Q1 2026.

The approval’s commercial significance rests on the disclosed $2.0 billion annual U.S. sales for this dosage/formulation category (12 months ended September 2025). Safety and labeled limitations remain factual constraints: the product’s most common adverse reaction is ocular burning, and the label notes no increased tear production in patients using topical anti‑inflammatory drugs or punctal plugs.

Watch the actual Q1 2026 launch timing, initial supply volumes, and early uptake versus the branded product. Near-term milestones to track include commercial availability in single-use vials and any company disclosures on launch distribution or inventory; assess these over the next 3–12 months.

• Approval underscores Amneal’s advanced sterile manufacturing capabilities and expansion within complex ophthalmic therapies; Launch expected in Q1 2026 
  

BRIDGEWATER, N.J., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation supplied in single-use vials. The product is the generic equivalent of RESTASIS^® (cyclosporine ophthalmic emulsion) 0.05%, a registered trademark of Allergan, an AbbVie company.

“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. “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 production is presumed to be suppressed 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.

The most common adverse reaction associated with cyclosporine ophthalmic emulsion 0.05% was ocular burning. Please see full Prescribing Information here.

According to IQVIA^® 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.

Note: RESTASIS^® is a registered trademark of Allergan, an AbbVie company.

About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.

Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com

Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com

FAQ

What did Amneal (AMRX) announce about cyclosporine ophthalmic emulsion on December 1, 2025?

Amneal announced U.S. FDA approval of cyclosporine ophthalmic emulsion 0.05% as a generic equivalent to RESTASIS, with a planned Q1 2026 launch.

How large is the U.S. market for cyclosporine ophthalmic emulsion 0.05% in single-use vials?

IQVIA reported approximately $2.0 billion in U.S. annual sales for this product format for the 12 months ended September 2025.

What formulation and packaging does Amneal’s approved cyclosporine use?

The approved product is a sterile, preservative-free ophthalmic emulsion supplied in single-use vials.

When will Amneal (AMRX) launch its cyclosporine ophthalmic emulsion 0.05%?

Amneal expects a U.S. launch in Q1 2026.

What are the main safety notes for Amneal’s cyclosporine ophthalmic emulsion 0.05%?

The most common adverse reaction was ocular burning; increased tear production was not seen in patients using topical anti-inflammatory drugs or punctal plugs.