Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2009:3:381-90.
doi: 10.2147/opth.s4460. Epub 2009 Jun 29.

The role of difluprednate ophthalmic emulsion in clinical practice

Karim N Jamal  1 , David G Callanan
Affiliations

The role of difluprednate ophthalmic emulsion in clinical practice

Karim N Jamal et al. Clin Ophthalmol. 2009.

Abstract

The mainstay in the treatment of ocular inflammation, either post-surgical or endogenous, is the use of steroids. While these agents effectively address inflammation, they are not without their risks, including ocular hypertension and acceleration of cataract formation. The most notorious culprits are the strong steroids, such as prednisolone acetate and betamethasone. This review aims to cover the biochemistry and drug development of difluprednate, a novel synthetic strong steroid emulsion. In vivo pharmacokinetics as well as ocular distribution and metabolism are discussed, followed by a comprehensive summary of phase I, II, and III clinical trials evaluating safety and efficacy in patients suffering from postoperative inflammation or anterior uveitis. The objective is to provide an increased familiarity with this newly approved medication as a welcome addition to the ophthalmologist's armamentarium.

Keywords: difluprednate; emulsion; ophthalmic surgery; steroid.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Difluprednate molecule.
Figure 2
Figure 2
Phase 3 postoperative trial: Percent of subjects with clinical response (anterior chamber cell count ≤5 and flare grade 0).
Figure 3
Figure 3
Phase 3 uveitis trial. Mean anterior chamber (AC) cell score over time.
Figure 4
Figure 4
Phase 3 open-label refractory uveitis trial. Anterior chamber (AC) cell score mean change from baseline.
Figure 5
Figure 5
Phase 3 open-label refractory uveitis trial. Percent of patients with anterior chamber (AC) cell score of 0 or 1.
Figure 6
Figure 6
Sirion phase 3 uveitis trial: anterior chamber (AC) cell score change over time.
Figure 7
Figure 7
Sirion phase 3 uveitis trial: pain score – mean change from baseline.
See this image and copyright information in PMC

References

    1. Apple DJ, Solomon KD, Tetz MR, et al. Posterior capsule opacification. Surv Ophthalmol. 1992;37:73–116. - PubMed
    1. Miyake K, Maekubo K, Miyake Y, et al. Pupillary fibrin membrane; a frequent early complication after posterior chamber lens implantation in Japan. Ophthalmol. 1989;96:1228–1233. - PubMed
    1. Schimmer BP, Parker KL. Adrenocorticotropic hormone; adrenocortical steroids and their synthetic analogs; inhibitors of the synthesis and actions of adrenocortical hormones. In: Hardman JG, Limbird LE, Gilman AG, editors. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 10th Edition. New York: McGraw–Hill; 2001. pp. 1649–1677.
    1. Sanders DR, Kraff M. Steroidal and nonsteroidal anti-inflammatory agents. Effect on postsurgical inflammation and blood–aqueous humor barrier breakdown. Arch Ophthalmol. 1984;102(10):1453–1456. - PubMed
    1. Korenfeld M. Difluprednate: changing the landscape of ocular pharmacology. Expert Rev Ophthamol. 2008;3(6):619–625.