Amneal Pharmaceuticals, Inc. has received FDA approval for prednisolone acetate ophthalmic suspension, 1% sterile—which references Allergan, Inc’s (AbbVie’s) Pred Forte—for the treatment of steroid-responsive ocular inflammation.
First up, tell me about Amneal.
Headquartered in Bridgewater, New Jersey, the global biopharmaceutical company develops, manufactures, and commercializes a broad portfolio of over 270+ generic and specialty products spanning various therapeutic areas.
Included among these product types: Complex oral solids, injectables, ophthalmics, liquids, topicals, softgels, inhalation products, and transdermals.
Next up: this suspension.
Prednisolone acetate is a sterile, topical anti-inflammatory agent intended for ophthalmic use as either a solution or suspension—and only available on a prescription-based basis.
Its general purpose: To treat certain mild-to-moderate non-infectious ocular allergies and inflammation, including damage caused by chemicals and thermal burns.
- But more specifically: Per its prescribing information (PI), the suspension treats steroid-responsive inflammation of the:
- Palpebral and bulbar conjunctiva
- Cornea
- Anterior segment of the globe
And its dosing schedule?
Two drops, applied topically, should be administered into the affected eye(s) four times daily.
To keep in mind:
- If signs and symptoms fail to improve after two days, a patient should be reevaluated
- Dosings may be reduced, but not discontinued prematurely
- In chronic conditions, withdrawal of treatment be done by gradually decreasing use
Let’s talk ingredients.
The active ingredient in this suspension is (obviously) prednisolone acetate—a glucocorticoid with three to five times the anti-inflammatory potency of hydrocortisone (another corticosteroid medicine).
- Some background on glucocorticoids: These are a type of corticosteroid hormone naturally produced by the adrenal glands and known for their anti-inflammatory and immunosuppressive properties
As for the suspension’s preservative: That would be benzalkonium chloride.
Got it. So, any contraindications or warnings to be aware of?
As its PI noted, the suspension is contraindicated in:
- Acute untreated purulent ocular infections
- Most viral diseases of the cornea and conjunctiva
- Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella
- Mycobacterial infection of the eye
- Fungal diseases of ocular structures
And patients are warned that prolonged use of corticosteroids may lead to posterior subcapsular cataract formation and increase their susceptibility to increased intraocular pressure (IOP).
- This may result in glaucoma with optic nerve damage and defects in visual acuity plus fields of vision
- See here for more potential ocular manifestations (under the warnings section)
And possible adverse reactions?
Aside from IOP elevation and glaucoma development, delayed wound healing and the development of secondary ocular infection—bacterial, fungal, and viral included—may occur.
Other reported reactions include (but are certainly not limited to): eye pain, headache, foreign body sensation in the eyes, burning and stinging upon instillation, blurry vision, keratitis, conjunctivitis, and corneal ulcers.
- More can be viewed here (under the adverse reactions section).
Now, isn’t prednisolone acetate already FDA approved?
Yes, in multiple concentrations (as both a suspension and solution).
For the 1% suspension form, prednisolone acetate was approved under the name Pred Forte (in 1966), and is currently owned by AbbVie via Allergan, Inc.
- To note: Amneal stated that its product references Pred Forte—meaning it has established bioequivalence to the already-approved drug.
A couple of notes on prenisolone product’s regulatory history in the U.S.:
- Sandoz launched Omnipred, its prednisolone acetate product, in 1982
- Lupin Limited launched the first generic of Pred Forte in the U.S. in October 2024 after receiving FDA approval in August 2024.
- Pred Forte was discontinued in November 2024 due to a drug shortage in the United States.
Interesting … so when can we expect Amneal’s suspension to be available?
The company expects to launch the product in the U.S. by Q3 2025.