FDA approves prednisolone acetate ophthalmic suspension for treating steroid-responsive ocular inflammation

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Amneal Pharmaceuticals announced the US Food and Drug Administration (FDA) has approved prednisolone acetate ophthalmic suspension, a sterile, topical anti-inflammatory agent for ophthalmic use that is indicated for treating steroid-responsive ocular inflammation.

Prednisolone acetate ophthalmic suspension, 1% sterile, references Pred Forte. Pred Forte and its design are trademarks of Allergan, Inc, an AbbVie company.

Andy Boyer, executive vice president and CCO of Affordable Medicines, commented on the approval in a press release from Amneal.

“Our Affordable Medicines portfolio continues to grow with a strong and diverse pipeline that supports broader access to high-quality treatments across the US healthcare system,” said Boyer. “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.”

The Affordable Medicines segment of Amneal expands across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars.

The US commercial launch of prednisolone acetate ophthalmic suspension is planned for Q3 of 2025.

The most commonly reported adverse reactions for prednisolone acetate ophthalmic suspension in clinical studies were elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

References:

1. Amneal receives US FDA approval for prednisolone acetate ophthalmic suspension. Published 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