FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular Inflammation

The US Food and Drug Administration (FDA) has approved prednisolone acetate ophthalmic suspension, USP 1%, a sterile, topical anti-inflammatory agent, for the treatment of steroid-responsive ocular inflammation. In addition to the approval, parent company Amneal Pharmaceuticals, Inc. announced a planned launch of the product for the third quarter of 2025.1

Ocular inflammation has been notoriously difficult to treat due to physiological barriers, such as frequent blinking and the tear film, which can lead to rapid drug clearance. Many commercial eyedrops also have low ocular bioavailability, requiring frequent dosing to maintain therapeutic levels.2

To that end, prednisolone acetate ophthalmic suspension, 1% is a self-administered eye drop intended for use 2-4 times daily. During the first 24 hours of treatment, this frequency may be increased if necessary.1

During clinical trials, the most common adverse reaction was elevation of intraocular pressure (IOP), followed by possible development of glaucoma, infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

Amneal Pharmaceuticals, Inc. has a diverse portfolio of >280 pharmaceuticals. Its Affordable Medicines segment, into which prednisolone acetate ophthalmic suspension falls, aims to spread further into complex product categories and therapeutic areas, including injectables and biosimilars.

“Our Affordable Medicines portfolio continues to grow with a strong and diverse pipeline that supports broader access to high-quality treatments across the U.S. healthcare system,” said Andy Boyer, Executive Vice President and Chief Commercial Officer, Affordable Medicines. “The approval of prednisolone acetate ophthalmic suspension—a complex product to develop and manufacture—highlights the depth of our R&D capabilities and the strength of our manufacturing and supply operations.”1

References

1. Amneal Pharmaceuticals, Inc. Amneal Receives U.S. FDA Approval for Prednisolone Acetate Ophthalmic Suspension. June 12, 2025. Accessed June 12, 2025. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Receives-U-S--FDA-Approval-for-Prednisolone-Acetate-Ophthalmic-Suspension/default.aspx

2. Zheng Y, Gu Y, Oz Y, et al. Mucoadhesive Micellar Eyedrops for the Treatment of Ocular Inflammation. Acta Biomater. Published online May 28, 2025. doi:10.1016/j.actbio.2025.05.065