Difluprednate 0.05% Suppliers & Bulk Manufacturers

Available Forms: Eye Drops

Available Strengths: 0.05%

Reference Brands: Durezol (USA)

Category: Opthalmology

Difluprednate is a potent corticosteroid used for treating inflammation and pain associated with eye surgeries or uveitis. It works by suppressing the inflammatory response, reducing swelling, redness, and discomfort in the eyes.

Product Description:

Difluprednate is a difluorinated derivative of prednisolone, formulated as an emulsion rather than a suspension. The two fluorine atoms increase potency and corneal penetration, and the emulsion means the drug is already dissolved in oil droplets, so it does not need shaking and the delivered dose is consistent — unlike a suspension, where inadequate shaking gives an unpredictable dose.

It is used for inflammation and pain after ocular surgery and for endogenous anterior uveitis, dosed four times daily and tapered, which is fewer drops than prednisolone acetate typically needs. Its potency is also its risk: it raises intraocular pressure more readily than weaker steroids, so pressure must be monitored during treatment, particularly in patients with glaucoma or known steroid response. Prolonged use causes cataract, delays healing and increases the risk of secondary bacterial, viral and fungal infection. It is contraindicated in active herpes simplex keratitis.

Sourcing notes. An oil-in-water emulsion, which is more demanding to manufacture than a suspension: droplet size distribution, physical stability and sterility assurance are the critical attributes. Registration is mainly in the US and Japan. Surgical centres are the buyers, and demand tracks cataract surgery volume.