
FDA approves prednisolone acetate ophthalmic suspension for treating steroid-responsive ocular inflammation
Key Takeaways
- FDA approved prednisolone acetate ophthalmic suspension for steroid-responsive ocular inflammation, referencing Pred Forte by Allergan, Inc.
- Amneal's approval highlights their R&D capabilities and manufacturing strength, expanding their Affordable Medicines portfolio.
Amneal Pharmaceuticals received FDA approval for its prednisolone acetate ophthalmic suspension, a steroid eye inflammation treatment referencing Allergan’s Pred Forte, with a US launch planned for Q3 2025.
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.
Reference
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
Newsletter
Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.