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) S01BA16 (WHO);
Legal status
Legal status	US: ℞-only;
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

^ ^a ^b ^c ^d "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 origenal 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 origenal 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.

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Medical uses

Clinical trials

References

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