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Xinyi Wang, Sharadrao M Patil, David A Keire, Xiaoming Xu, Kang Chen
Generic drug products are expected to have the same active pharmaceutical ingredient (API) (Q1) with the same content (Q2) and microstructure arrangement (Q3) as the innovator product. In complex oil-in-water emulsion drugs, the hydrophobic API is mainly formulated in oil droplets stabilized by surfactant and micelles composed of extra surfactant molecules. The API phase partition in oil and water (mainly micelle) is a critical quality attribute (CQA) of emulsion product in demonstrating physicochemical equivalence using difluprednate (DFPN) emulsion product Durezol® as a model, we developed a novel low-field benchtop NMR method to demonstrate its applicability in measuring DFPN phase partition for ophthalmic oil-in-water emulsion products...
May 2018: AAPS PharmSciTech
Rozemarijn S Verhoeven, Andres Garcia, RiLee Robeson, Brian C Gilger, David Culp, Craig Struble, Lee Hamm, Tomas Navratil, Benjamin Yerxa
PURPOSE: Topical corticosteroids are widely used in the treatment of inflammation and pain after ocular surgery, but they possess several shortcomings, including frequent dosing and low patient adherence. We evaluated the efficacy and pharmacokinetics of ENV905 (difluprednate or DFBA) Ophthalmic Implant, a single-dose drug delivery system, compared with 0.05% Durezol. METHODS: PRINT® technology was used to fabricate ENV905 implants for either intracameral (IC) or subconjunctival (SCJ) delivery of extended-release DFBA...
January 2018: Journal of Ocular Pharmacology and Therapeutics
T Borrás, L K Buie, M G Spiga
Current treatment of glaucoma relies on administration of daily drops or eye surgery. A gene therapy approach to treat steroid-induced glaucoma would bring a resolution to millions of people worldwide who depend on glucocorticoid therapy for a myriad of inflammatory disorders. Previously, we had characterized a short-term Adh.GRE.MMP1 gene vector for the production of steroid-induced MMP1 in the trabecular meshwork and tested reduction of elevated intraocular pressure (IOP) in a sheep model. Here we conducted a trial transferring the same transgene cassette to a clinically safe vector (scAAV2), and extended the therapeutic outcome to longer periods of times...
2016: Gene Therapy
Kv Chalam, Vijay Khetpal, Chirag J Patel
INTRODUCTION: Pseudophakic cystoid macular edema is a common cause of poor vision after cataract surgery, and topical corticosteroids and nonsteroidal anti-inflammatory drugs are used for its treatment. We investigated the effectiveness of difluprednate (Durezol(®), recently approved by the US Food and Drug Administration) in the treatment of cystoid macular edema, assisted with spectral domain optical coherence tomography (SD-OCT). CASE REPORT: A 63-year-old African-American woman presented 6 weeks after uneventful cataract surgery in her left eye with decreased vision and associated distortion of the central visual field...
2012: Clinical Ophthalmology
Sakiko Nakano Goto, Teiko Yamamoto, Eriko Kirii, Sachi Abe, Hidetoshi Yamashita
PURPOSE:  To evaluate the efficacy of treatment of diffuse diabetic macular oedema (DME) with difluprednate ophthalmic emulsion 0.05% (Durezol™) in eyes before vitrectomy. METHODS: This study enrolled patients with diffuse DME for whom more than 3 months had passed since prior treatment. Nineteen eyes in 15 subjects were treated with difluprednate ophthalmic emulsion 0.05% four times daily for the first month and then twice daily for 2 months (treatment group)...
November 2012: Acta Ophthalmologica
Kelly Meehan, Lori Vollmer, Joseph Sowka
INTRODUCTION: Difluprednate ophthalmic emulsion 0.05% (Durezol™, Alcon, Fort Worth, Texas) is a topical difluorinated derivative of prednisolone with potent anti-inflammatory activity. Difluprednate 0.05% has a reported associated increase in intraocular pressure (IOP) in 3% of patients. Although the occurrence may be low, the possible elevation in IOP may be substantially higher than commonly encountered with other topical steroids. CASE REPORTS: A 49-year-old black man presented with a traumatic anterior uveitis recalcitrant to traditional prednisolone acetate 1% treatment...
December 2010: Optometry: Journal of the American Optometric Association
William Stringer, Roy Bryant
PURPOSE: To compare the dose uniformity of difluprednate ophthalmic emulsion 0.05% (Durezol(®)) with both branded and generic prednisolone acetate ophthalmic suspension 1% under different simulated patient usage conditions. METHODS: Drug concentrations of difluprednate emulsion, branded prednisolone acetate suspension (Pred Forte(®)) and generic prednisolone acetate suspension following three storage conditions (upright, then shaken; upright, not shaken; inverted, not shaken) were analyzed by high performance liquid chromatography assay and results were reported as percent of declared concentration...
2010: Clinical Ophthalmology
Stephen Smith, Douglas Lorenz, James Peace, Kimberly McLeod, R S Crockett, Roger Vogel
OBJECTIVE: To evaluate the efficacy and safety of twice-daily difluprednate ophthalmic emulsion 0.05% (Durezol(®)) versus placebo administered before surgery for managing inflammation and pain following cataract extraction. METHODS: Eligible subjects (N = 121) were randomized 2:1 to topical treatment with 1 drop difluprednate or placebo administered twice daily for 16 days, followed by a 14-day tapering period. Dosing was initiated 24 hours before unilateral ocular surgery...
September 7, 2010: Clinical Ophthalmology
C Stephen Foster, Robert Davanzo, Thomas E Flynn, Kimberly McLeod, Roger Vogel, R Steve Crockett
PURPOSE: The aim of this study was to evaluate the efficacy and safety of difluprednate ophthalmic solution 0.05% (Durezol; Alcon Laboratories, Fort Worth, TX) compared with prednisolone acetate ophthalmic suspension 1% (Pred Forte; Allergan, Inc., Irvine, CA) for endogenous anterior uveitis. METHODS: In this phase 3, multicenter, randomized, noninferiority trial, 90 patients with endogenous anterior uveitis [>10 anterior chamber (AC) cells and an AC flare score of ≥2 in at least 1 eye] received either difluprednate 4x /day (QID) (n=50) or prednisolone 8x/day (n=40) for 14 days, followed by a 2-week tapering regimen...
October 2010: Journal of Ocular Pharmacology and Therapeutics
Sakiko Nakano, Teiko Yamamoto, Eriko Kirii, Sachi Abe, Hidetoshi Yamashita
PURPOSE: To evaluate the efficacy of treatment of refractory diabetic macular edema (DME) after vitrectomy with difluprednate ophthalmic emulsion 0.05% (Durezol(TM)), and to compare this treatment with sub-Tenon's injection of triamcinolone (STTA). METHODS: This study enrolled patients with refractory diabetic macular edema that persisted despite pars plana vitrectomy in our clinic. In all subjects, more than 3 months had passed since prior treatment. Eleven eyes in ten subjects were treated with STTA (STTA group), and 11 eyes in seven subjects were treated with difluprednate ophthalmic emulsion 0...
June 2010: Graefe's Archive for Clinical and Experimental Ophthalmology
Michael S Korenfeld, Steven M Silverstein, David L Cooke, Roger Vogel, Robert S Crockett
PURPOSE: To assess the efficacy and safety of difluprednate ophthalmic emulsion 0.05% (Durezol) 2 or 4 times a day compared with those of a placebo in the treatment of inflammation and pain associated with ocular surgery. SETTING: Twenty-six clinics in the United States. METHODS: One day after unilateral ocular surgery, patients who had an anterior chamber cell grade of 2 or higher (>10 cells) were treated with 1 drop of difluprednate 2 times or 4 times a day or with a placebo (vehicle) 2 times or 4 times a day in the study eye for 14 days...
January 2009: Journal of Cataract and Refractive Surgery
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