A new option enters the American market for treating ocular inflammation.
Amneal Pharmaceuticals (New Jersey, United States) announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved prednisolone acetate ophthalmic suspension, USP 1% sterile, a topical anti-inflammatory agent for ophthalmic use.
The drug is indicated for the treatment of steroid-responsive ocular inflammation of palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. It acts as a topical corticosteroid, effectively reducing redness, swelling and discomfort in the eye.
The newly approved drug references Pred Forte, a well-known brand from Allergan, an AbbVie company, and has established bioequivalence to that branded drug. As a result, Amneal’s formulation is expected to deliver the same therapeutic benefit.
The company plans to commercially launch the product in the third quarter of 2025.
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“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,” said Andy Boyer, EVP and chief commercial officer, Affordable Medicines.
Previously approved treatments
This product joins other approved prednisolone acetate options in the U.S. market, including Omnipred by Sandoz (Basel, Switzerland) and a generic version from Lupin Limited (Mumbai, India), approved by the FDA in August 2024 and launched in October 2024.
As with many steroid-based eye drops, clinical studies reported possible side effects such as elevated intraocular pressure (IOP), potential glaucoma, optic nerve damage, posterior subcapsular cataract and delayed wound healing.
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The ocular inflammation landscape
Amneal’s candidate enters a favorable market at a time when the myriad conditions classified as anterior ocular inflammatory diseases (AIODs) are on the rise.
A 2019 study found that AIOD drugs, which include those for dry eye, represented a staggering 40% of the total ophthalmic drug market. Of these drugs, anti-inflammatory agents were found to make up 29% of the nearly $11 billion total AIOD segment.¹
Editor’s note: For more details, see Amneal Pharmaceuticals’ full press release. For prescribing information, refer to the product’s official package insert. This content is intended exclusively for healthcare professionals. It is not intended for the general public. Products or therapies discussed may not be registered or approved in all jurisdictions, including Singapore.
Reference
- Khan RS, Rizvi S, Syed BA, Bielory L. Current market trends in anterior ocular inflammatory disease landscape. Curr Opin Allergy Clin Immunol. 2019;19(5):503-509.