FDA approves Amneal formulation of prednisolone acetate ophthalmic solution 1%
The generic formulation references Pred Forte, which is trademarked by Allergan.
The US commercial launch of prednisolone acetate ophthalmic suspension is planned for Q3 of 2025.
(Image credit: ©KMPZZZ—stock.adobe.com)
The FDA has approved a new formulation of prednisolone acetate ophthalmic suspension 1% sterile from Amneal Pharmaceuticals. The sterile, topical anti-inflammatory agent is indicated for treating steroid-responsive ocular inflammation and is intended for ophthalmic use only.
The suspension references Pred Forte, which is trademarked by Allergan, and AbbVie company. Amneal intends to launch the drop in the third quarter of 2025.
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 health care 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
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