Difluprednate

Overview

Difluprednate is a topical corticosteroid indicated for the treatment of infammation and pain associated with ocular surgery. It is a butyrate ester of 6(α), 9(α)-difluoro prednisolone acetate. Difluprednate is abbreviated DFBA, or difluoroprednisolone butyrate acetate. It is indicated for treatment of endogenous anterior uveiti.

Indication

For the treatment of inflammation and pain associated with ocular surgery.

Associated Conditions

Anterior Uveitis (AU)
Endogenous Anterior Uveitis
Eye Pain
Ocular Inflammation
Pain of the eye

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II	2024/02/22	NCT06271772	Phase 3	Recruiting	University of California, San Francisco
A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification	2022/12/13	NCT05649111	Phase 4	Recruiting	Kafrelsheikh University
Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery	2020/12/29	NCT04687800	Phase 4	Terminated	Cathleen McCabe MD
Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.	2020/11/17	NCT04631315	Phase 4	Completed	Laboratorios Poen
Steroids and Cross-linking for Ulcer Treatment	2019/09/20	NCT04097730	Phase 3	Completed	Thomas M. Lietman
Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification	2018/10/03	NCT03693989	Phase 3	Completed	Laboratorios Sophia S.A de C.V.
Evaluation of Efficacy and Safety of SDN-037	2018/02/08	NCT03426267	Phase 3	Completed	Sun Pharma Advanced Research Company Limited
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial	2013/09/11	NCT01939691	Phase 4	Terminated	University of California, San Francisco
Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients	2011/01/13	NCT01276223	Phase 2	Completed	Alcon Research
Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.	2010/11/19	NCT01244334	Phase 4	Completed	Edward J. Holland

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Difluprednate Ophthalmic	Sandoz Inc	0781-6000	OPHTHALMIC	0.5 mg in 1 mL	9/27/2021
Difluprednate Ophthalmic Emulsion	Dr. Reddy's Laboratories Inc.	43598-588	OPHTHALMIC	0.5 mg in 1 mL	7/1/2020
DIFLUPREDNATE	Cipla USA Inc.	69097-341	OPHTHALMIC	0.5 mg in 1 mL	4/10/2020
DUREZOL	Physicians Total Care, Inc.	54868-6296	OPHTHALMIC	0.5 mg in 1 mL	9/2/2011
DIFLUPREDNATE	Exelan Pharmaceuticals, Inc.	76282-708	OPHTHALMIC	0.5 mg in 1 mL	12/10/2021
DUREZOL	Novartis Pharmaceuticals Corporation	0078-0862	OPHTHALMIC	0.5 mg in 1 mL	11/15/2020
Difluprednate	Amneal Pharmaceuticals NY LLC	69238-1380	OPHTHALMIC	0.5 mg in 1 mL	12/29/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Zhaoke Ophthalmology's TAB014 Shows Positive Phase 3 Results; Valo Health Shelves OPL-0401

6 months ago

• Zhaoke Ophthalmology's TAB014 met primary and key secondary endpoints in a Phase 3 trial for wet age-related macular degeneration (AMD). • Caplin Steriles received FDA approval for its generic difluprednate ophthalmic emulsion, used to treat inflammation and pain after ocular surgery. • Valo Health will seek a partner for OPL-0401, a diabetic retinopathy drug, after it failed to meet endpoints in the SPECTRA trial. • GEMMABio secured $34 million in seed funding to advance its gene therapy programs, focusing on rare diseases in Brazil.

Caplin Steriles Gains FDA Approval for Generic Difluprednate Eye Drops

7 months ago

• Caplin Steriles has received FDA approval for its generic version of difluprednate ophthalmic emulsion, 0.05%, a therapeutic equivalent to DUREZOL. • The approval allows Caplin Steriles to market a more affordable alternative for treating inflammation and pain associated with ocular surgery. • This generic medication mirrors Sandoz Inc.'s DUREZOL, offering similar efficacy and safety profiles for patients requiring corticosteroid treatment in the eye. • The FDA's decision underscores Caplin Steriles' commitment to providing accessible and cost-effective pharmaceutical options in the ophthalmology space.

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