The role of difluprednate ophthalmic emulsion in clinical practice

Jamal, Karmin N; Callanan, David

doi:10.2147/opth.s4460

Cited by 25 publications

(10 citation statements)

References 34 publications

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“…Emulsions also contain a surfactant, which acts as a stabilizer, preventing the oil droplets from coalescing and allowing aqueous compatibility. 6 Thus, emulsions create homogeneous dispersions that are not subject to sedimentation or aggregation. Empirically, emulsions have been shown to produce greater ocular bioavailability than suspensions, as demonstrated by a pharmacokinetic study conducted in rabbits, in which a corticosteroid emulsion showed a 4.1-fold higher area under the curve (AUC) in aqueous humor and a 4.6-fold higher AUC in cornea than the same corticosteroid formulated as a suspension.…”

Section: Discussionmentioning

confidence: 99%

Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%

Stringer¹,

Bryant²

2010

OPTH

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PurposeTo 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.MethodsDrug 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. Two drops were dispensed every four hours four times daily.ResultsRegardless of bottle orientation and shaking, all difluprednate emulsion concentrations at each time point analyzed were within 15% of declared concentration. Both branded and generic prednisolone acetate suspension concentrations varied substantially throughout the study. For the bottle stored upright and not shaken, 46% of the branded concentrations were not within 15% of declared concentration; for the bottle stored upright and shaken prior to use, 60% failed to meet this criterion. None of the branded concentrations from the inverted and not shaken bottle was within 15% of declared concentration. Generic prednisolone concentrations demonstrated the poorest dose uniformity, with 96% of the concentrations from the inverted and not shaken bottle not within 15% of declared concentration; 94% of the concentrations from the upright and shaken bottle and 87% from the upright and not shaken bottle similarly failed to meet this criterion.ConclusionsDose uniformity of Durezol emulsion was predictable in all simulated patient usage conditions, whereas the drop concentrations of Pred Forte and generic prednisolone acetate suspensions were highly variable throughout the study. Drop concentrations are more predictable with Durezol emulsion than with either prednisolone acetate suspension.

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Section: Discussionmentioning

confidence: 99%

Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%

Stringer¹,

Bryant²

2010

OPTH

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“…Topical corticosteroids are the most common medication prescribed to prevent immunologic rejection after keratoplasty, but there are important differences in the postoperative management protocols [3][4][5][6]. Although weaker steroids may have better safety profiles, some patients will require the strongest available drug to control their inflammation [5][6][7][8]. The most widely prescribed topical corticosteroid in the world is prednisolone acetate 1% [6].…”

Section: Introductionmentioning

confidence: 99%

“…The most widely prescribed topical corticosteroid in the world is prednisolone acetate 1% [6]. Not all medications are available worldwide, for example, the high-potency steroid difluprednate (Durezol™, Alcon Laboratories Inc., Fort Worth, TX, USA) [8].…”

Section: Introductionmentioning

confidence: 99%

Literature review and suggested protocol for prevention and treatment of corneal graft rejection

Magalhaes

Bardan

Zarei-Ghanavati

et al. 2019

Eye

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Effective prophylaxis and treatment of corneal graft rejection are essential to improve outcomes in corneal transplantation. To date, there has been no standardized protocol published that outlines the optimal prophylactic and therapeutic approaches and, furthermore, the published controlled trials on this subject are limited. Likewise, no study has addressed how the level of antigen exposure varies between different types of keratoplasties. The aim of this paper is to provide a simple evidencebased protocol for the prevention and treatment of corneal graft rejection.

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“…[ 31 ] Furthermore, difluprednate, a novel strong synthetic steroid emulsion, has become widely accepted in the treatment of postoperative inflammation as well as in high-risk eyes. [ 32 ] High-risk corneal allografts need to be more intensively treated and for a longer duration, and the efficacy of prolonged use of topical steroids for the prevention of rejection after PKP has been shown. [ 33 ]…”

Section: Discussionmentioning

confidence: 99%

Impact of pandemic COVID-19 lockdown on penetrating keratoplasty patients

Sharma

Mamatha

Sharma

et al. 2022

Indian Journal of Ophthalmology

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Purpose: To study the impact of the COVID-19 lockdown on the regular follow-up of keratoplasty patients. Methods: This retrospective interventional case series included 30 patients who had immunological corneal endothelial rejection out of 190 patients who came for post-PKP follow-up between September 15, 2019, and September 30, 2020. The demographics, primary diagnosis, surgical technique, time of presentation, recovery of graft, associated ocular problems, and visual acuity at 1 month were analyzed. Forward stepwise (likelihood ratio) binary logistic regression was used to find significant variables. Results: The study population had 19 males (63.33%) and 11 females (36.67%). The mean age of the study group was 42.83 ± 18.89 (8–80) years. Of 30 patients, 19 (63.3%) presented before and 11 (36.7%) after the COVID-19 lockdown. Overall, 23 (77%) showed a reversal of graft rejection. Logistic regression showed that preoperative indications, large-sized grafts, and deep corneal vascularization were significant risk factors for non-resolution of graft rejection. It was noted that patients who presented to the hospital late had poor recovery ( P = 0.002). The delay in the presentation was a significant risk factor for non-resolution of graft rejection ( P < 0.01). Z-test for proportions revealed that the difference in the non-resolution of rejection on immediate or delayed treatment in patients presenting during lockdown ( P = 0.002) was significant. Conclusion: This article is to highlight the impact of the COVID-19 lockdown on graft rejection recovery of PKP patients due to delays in follow-up. Early treatment helps in the recovery of graft transparency and the reversal of immunological graft rejection. Also, primary diagnosis, deep vascularization, and large-sized grafts were significant risk factors for non-resolution of graft rejection.

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The role of difluprednate ophthalmic emulsion in clinical practice

Cited by 25 publications

References 34 publications

Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%

Dose uniformity of topical corticosteroid preparations: difluprednate ophthalmic emulsion 0.05% versus branded and generic prednisolone acetate ophthalmic suspension 1%

Literature review and suggested protocol for prevention and treatment of corneal graft rejection

Impact of pandemic COVID-19 lockdown on penetrating keratoplasty patients

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