Company Overview and Product Portfolio

Amneal Pharmaceuticals, a global biopharmaceutical company headquartered in Bridgewater, New Jersey, develops, manufactures, and markets over 270 generic and specialty pharmaceutical products. Their portfolio includes complex oral solids, injectables, ophthalmics, liquids, topicals, and transdermals. The company focuses on expanding affordable access to complex therapies across the U.S. healthcare system.

Product Details and Indications

Prednisolone acetate ophthalmic suspension USP 1% is a sterile, topical anti-inflammatory formulation designed for the treatment of steroid-responsive ocular inflammation. It is available by prescription and references Allergan, Inc.’s (an AbbVie company) Pred Forte®. The suspension targets inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. It is indicated for a broad range of ophthalmic inflammatory conditions, including uveitis and post-operative inflammation.

Dosage and Administration

The drug is self-administered as two drops topically in the affected eye(s) four times daily, with the possibility of increasing frequency up to hourly during the first 24 hours if medically necessary. This flexible dosing regimen allows physicians to tailor treatment intensity according to inflammation severity.

Clinical Safety Profile

In clinical trials, the most commonly reported adverse reactions included elevation of intraocular pressure (IOP), with the potential to develop glaucoma, and rare instances of optic nerve damage. Other side effects included posterior subcapsular cataract formation and delayed wound healing. Patients require careful monitoring for increased IOP during therapy, especially with extended use.

Manufacturing and Market Launch

Amneal emphasized the product’s complex development and manufacturing processes, highlighting its robust research and development capabilities and supply chain strength. The company plans a commercial launch during the third quarter of 2025, positioning the product as a significant addition to the ophthalmology treatment landscape, particularly for patients needing effective steroid therapy with an accessible generic alternative.

Market Position and Competitive Landscape

According to IQVIA data, annual U.S. sales for prednisolone acetate ophthalmic suspension approximated $201 million for the 12 months ending April 2025, reflecting strong patient demand. Amneal aims to leverage this approval to reinforce its presence in the ophthalmic segment and support broader healthcare access.