Difluprednate

Difluprednate
Clinical data
Trade names	Durezol
AHFS/Drugs.com	Monograph
MedlinePlus	a609025
License data	US FDA: Difluprednate;
Routes of; administration	Eye drops
ATC code	D07AC19 (WHO) ;
Legal status
Legal status	US: ℞-only[1];
Identifiers
	IUPAC name [(6S,8S,9R,10S,11S,13S,14S,17R)-17-(2-acetyloxyacetyl)-6,9-difluoro-11-hydroxy-10,13-dimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] butanoate;
CAS Number	23674-86-4 ;
PubChem CID	32037;
DrugBank	DB06781 ;
ChemSpider	391990 ;
UNII	S8A06QG2QE;
KEGG	D01266 ;
ChEBI	CHEBI:31485;
ChEMBL	ChEMBL1201749 ;
CompTox Dashboard (EPA)	DTXSID0046773 ;
ECHA InfoCard	100.041.636
Chemical and physical data
Formula	C27H34F2O7
Molar mass	508.559 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES [H][C@@]12CC[C@](OC(=O)CCC)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C;
	InChI InChI=1S/C27H34F2O7/c1-5-6-23(34)36-26(22(33)14-35-15(2)30)10-8-17-18-12-20(28)19-11-16(31)7-9-24(19,3)27(18,29)21(32)13-25(17,26)4/h7,9,11,17-18,20-21,32H,5-6,8,10,12-14H2,1-4H3/t17-,18-,20-,21-,24-,25-,26-,27-/m0/s1; Key:WYQPLTPSGFELIB-JTQPXKBDSA-N;
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Difluprednate, sold under the brand name Durezol, is a corticosteroid used for the treatment of post-operative ocular inflammation and pain.[1]

It was approved for medical use in the United States in June 2008.[1][2][3] It is available as a generic medication.[4]

Medical uses

Difluprednate is indicated for the treatment of inflammation and pain associated with ocular surgery; and the treatment of endogenous anterior uveitis.[1]

Clinical trials

Difluprednate ophthalmic emulsion 0.05% is also being studied in other ocular inflammatory diseases, including a phase 3 study evaluating difluprednate for the treatment of anterior uveitis[5][6]

References

"Durezol emulsion". DailyMed. 11 July 2022. Retrieved 7 March 2023.
"Drug Approval Package: Durezol (Difluprednate) NDA #022212". U.S. Food and Drug Administration (FDA). 25 July 2008. Retrieved 7 March 2023.
"Sirion Therapeutics Announces FDA Approval of Durezol for Treatment of Postoperative Ocular Inflammation and Pain" (Press release). Sirion Therapeutics, Inc. 2008-06-24. Retrieved 2008-06-30.
"Competitive Generic Therapy Approvals". U.S. Food and Drug Administration (FDA). 29 June 2023. Archived from the original on 29 June 2023. Retrieved 29 June 2023.
Clinical trial number NCT00501579 for "Study of Difluprednate in the Treatment of Uveitis" at ClinicalTrials.gov
Sheppard JD, Toyos MM, Kempen JH, Kaur P, Foster CS (May 2014). "Difluprednate 0.05% versus prednisolone acetate 1% for endogenous anterior uveitis: a phase III, multicenter, randomized study". Investigative Ophthalmology & Visual Science. 55 (5): 2993–3002. doi:10.1167/iovs.13-12660. PMC 4581692. PMID 24677110.

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[Durezol_FDA_label-1] "Durezol emulsion". DailyMed. 11 July 2022. Retrieved 7 March 2023.

[2] "Drug Approval Package: Durezol (Difluprednate) NDA #022212". U.S. Food and Drug Administration (FDA). 25 July 2008. Retrieved 7 March 2023.

[3] "Sirion Therapeutics Announces FDA Approval of Durezol for Treatment of Postoperative Ocular Inflammation and Pain" (Press release). Sirion Therapeutics, Inc. 2008-06-24. Retrieved 2008-06-30.

[4] "Competitive Generic Therapy Approvals". U.S. Food and Drug Administration (FDA). 29 June 2023. Archived from the original on 29 June 2023. Retrieved 29 June 2023.

[5] Clinical trial number NCT00501579 for "Study of Difluprednate in the Treatment of Uveitis" at ClinicalTrials.gov

[Sheppard_2014-6] Sheppard JD, Toyos MM, Kempen JH, Kaur P, Foster CS (May 2014). "Difluprednate 0.05% versus prednisolone acetate 1% for endogenous anterior uveitis: a phase III, multicenter, randomized study". Investigative Ophthalmology & Visual Science. 55 (5): 2993–3002. doi:10.1167/iovs.13-12660. PMC 4581692. PMID 24677110.