difluprednate and Uveitis--Anterior

PurposeTo evaluate safety and efficacy of difluprednate 0.05% ophthalmic emulsion for treatment of postoperative inflammation after cataract surgery in pediatric patients.MethodsThis was a phase 3B, multicentre, randomized, double-masked, active-controlled study of patients aged 0-3 years who underwent uncomplicated cataract surgery in one eye, with/without intraocular lens implantation. Patients were randomized to receive difluprednate 0.05% four times daily or prednisolone acetate 1% for 14 days post surgery, followed by tapering for 14 days. Safety included evaluation of adverse events. Primary efficacy was the proportion of patients with an anterior cell grade of 0 (no cells) at day 14; secondary efficacy was a global inflammation score.ResultsForty patients were randomized to each treatment group. Adverse drug reactions included corneal oedema (difluprednate 0.5%, n=1; prednisolone acetate 1%, n=0) and increased intraocular pressure or ocular hypertension (n=2/group). Mean intraocular pressure values during treatment were 2-3 mm Hg higher with difluprednate 0.05% compared with prednisolone acetate 1%; mean values were similar between groups by the first week after treatment cessation. At 2 weeks post surgery, the incidence of complete clearing of anterior chamber cells was similar between groups (difluprednate 0.05%, n=30 (78.9%); prednisolone acetate 1%, n=31 (77.5%). Compared with prednisolone acetate 1%, approximately twice as many difluprednate 0.05%-treated patients had a global inflammation assessment score indicating no inflammation on day 1 (n=12 (30.8%) vs n=7 (17.5%) and day 8 (n=18 (48.7%) vs n=10 (25.0%).ConclusionsDifluprednate 0.05% four times daily showed safety and efficacy profiles similar to prednisolone acetate 1% four times daily in children 0-3 years undergoing cataract surgery.

Topics: Administration, Topical; Aphakia, Postcataract; Cataract; Cataract Extraction; Child, Preschool; Double-Blind Method; Female; Fluprednisolone; Glucocorticoids; Humans; Infant; Infant, Newborn; Inflammation; Intraocular Pressure; Lens Implantation, Intraocular; Male; Ophthalmic Solutions; Prednisolone; Uveitis, Anterior

Endogenous anterior uveitis (AU), when untreated, may lead to vision loss. This study compared the safety and efficacy of difluprednate versus prednisolone acetate for the treatment of this condition.. This phase III, double-masked, noninferiority study randomized patients with mild to moderate endogenous AU to receive difluprednate 0.05% (n = 56) four times daily, alternating with vehicle four times daily, or prednisolone acetate 1% (n = 54) eight times daily. The 14-day treatment period was followed by a 14-day dose-tapering period and a 14-day observation period. The primary efficacy end point was change in anterior chamber cell grade (range, 0 for ≤1 cell to 4 for >50 cells) from baseline to day 14.. At day 14, the mean change in anterior chamber cell grade with difluprednate was noninferior to that with prednisolone acetate (-2.2 vs. -2.0, P = 0.16). The proportions of difluprednate-treated patients versus prednisolone acetate-treated patients demonstrating complete clearing of anterior chamber cells at day 3 were 13.0% vs. 2.1% (P = 0.046) and at day 21 were 73.9% vs. 63.8% (P = 0.013). A significant between-group difference in the mean IOP increase was seen at day 3 (2.5 mm Hg for difluprednate-treated patients and 0.1 mm Hg for prednisolone acetate-treated patients, P = 0.0013) but not at other time points. The mean IOP values in both groups remained less than 21 mm Hg throughout the study.. Difluprednate 0.05% four times daily is well tolerated and is noninferior to prednisolone acetate 1% eight times daily for the treatment of endogenous AU. (ClinicalTrials.gov number, NCT01201798.).

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Analysis of Variance; Anterior Chamber; Anti-Inflammatory Agents; Child; Double-Blind Method; Drug Administration Schedule; Female; Fluprednisolone; Glucocorticoids; Humans; Intraocular Pressure; Male; Middle Aged; Prednisolone; Uveitis, Anterior; Young Adult

To compare the effects of 2 corticosteroids on corneal thickness and visual acuity after cataract surgery.. Multicenter, randomized, contralateral-eye, double-masked trial.. Fifty-two patients (104 eyes) underwent bilateral phacoemulsification. The first eye randomly received difluprednate 0.05% or prednisolone acetate 1%; the fellow eye received the alternative. Before surgery, 7 doses were administered over 2 hours; 3 additional doses were given after surgery, before discharge. For the remainder of the day, corticosteroids were administered every 2 hours, then 4 times daily during week 1 and twice daily during week 2. Corneal pachymetry, visual acuity, and corneal edema were evaluated before surgery and at days 1, 15, and 30 after surgery. Endothelial cell counts were evaluated before surgery and at 30 days after surgery. Retinal thickness was evaluated before surgery and at 15 and 30 days after surgery.. Corneal thickness at day 1 was 33 μm less in difluprednate-treated eyes (P = .026). More eyes were without corneal edema in the difluprednate group than in the prednisolone group at day 1 (62% vs 38%, respectively; P = .019). Uncorrected and best-corrected visual acuity at day 1 were significantly better with difluprednate than prednisolone by 0.093 logMAR lines (P = .041) and 0.134 logMAR lines (P < .001), respectively. Endothelial cell density was 195.52 cells/mm(2) higher in difluprednate-treated eyes at day 30 (P < .001). Retinal thickness at day 15 was 7.74 μm less in difluprednate-treated eyes (P = .011).. In this high-dose pulsed-therapy regimen, difluprednate reduced inflammation more effectively than prednisolone acetate, resulting in more rapid return of vision. Difluprednate was superior at protecting the cornea and reducing macular thickening after cataract surgery.

Topics: Aged; Aged, 80 and over; Cell Count; Cornea; Corneal Edema; Double-Blind Method; Endothelium, Corneal; Female; Fluprednisolone; Glucocorticoids; Humans; Inflammation; Intraocular Pressure; Lens Implantation, Intraocular; Male; Middle Aged; Phacoemulsification; Prednisolone; Prospective Studies; Pulse Therapy, Drug; Refraction, Ocular; Uveitis, Anterior; Visual Acuity

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.. 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. The main outcome measure was change from baseline in AC cell grade on day 14.. At day 14, mean AC cell grade improvement for difluprednate-treated patients was similar to prednisolone-treated patients (2.1 vs. 1.9, respectively), proving noninferiority. At day 14, 68.8% of difluprednate patients had AC cell clearing (grade 0:≥ 1cell) compared with 61.5% of prednisolone patients. In the prednisolone-treated group, 12.5% of patients were withdrawn because of investigator-determined lack of efficacy; no difluprednate-treated patients were withdrawn for this reason (P=0.01). Clinically significant intraocular pressure elevation occurred in 3 difluprednate-treated patients (6.0%) and 2 prednisolone-treated patients (5.0%).. Difluprednate administered QID is at least as effective as prednisolone administered 8x/day in resolving the inflammation and pain associated with endogenous anterior uveitis. Difluprednate provides effective treatment for anterior uveitis and requires less frequent dosing than prednisolone acetate.. Trial NCT00501579 was registered at the National Institutes of Health Registry in July 2007 ( http://clinicaltrials.gov/ct2/show/NCT00501579?term=sirion&rank=4 ).

Topics: Adult; Anterior Chamber; Anti-Inflammatory Agents; Emulsions; Female; Fluprednisolone; Glucocorticoids; Humans; Intraocular Pressure; Male; Middle Aged; Prednisolone; Suspensions; Treatment Outcome; Uveitis, Anterior; Visual Acuity; Young Adult

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.. Twenty-six clinics in the United States.. 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. This was followed by a 14-day tapering period and a 7-day safety evaluation. Outcome measures included cleared anterior chamber inflammation (grade 0, or=10 mm Hg and >or=21 mm Hg from baseline, respectively) versus 1% in the placebo group.. Difluprednate given 2 or 4 times a day cleared postoperative inflammation and reduced pain rapidly and effectively. There were no serious ocular adverse events. Fewer adverse events were reported in the difluprednate-treated groups than in the placebo group.

Topics: Adult; Aged; Aged, 80 and over; Anterior Chamber; Cell Count; Double-Blind Method; Emulsions; Female; Fluprednisolone; Glucocorticoids; Humans; Inflammation; Male; Middle Aged; Ophthalmic Solutions; Ophthalmologic Surgical Procedures; Pain; Postoperative Complications; Uveitis, Anterior

Drug-induced uveitis is a well-known effect of ocular inflammation that has been reported with many medications. Pembrolizumab is a newer generation of the anti-programmed cell death-1 monoclonal antibodies that was recently approved by the Food and Drug Administration for the treatment of advanced melanoma. Immune-mediated adverse events involving different organs have been reported in recent literature in association with this drug. We present the first reported case of uveitis in association with pembrolizumab therapy.. An 82-year-old man with stage IV melanoma was started on pembrolizumab infusion treatment every 3 weeks. Two months after initiating therapy, he presented with bilateral severe anterior uveitis and papillitis with fast and complete recovery after withholding further pembrolizumab infusions and treatment with topical steroid. Uveitis recurred after restarting pembrolizumab therapy.. In current clinical practice, many new drugs are being approved, requiring better characterization of the prevalence, onset, and nature of adverse events in order to aid development of effective management strategies. Ophthalmologists should keep in mind that drugs are always a possible cause of ocular inflammation in patients presenting with uveitis.

Topics: Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Fluprednisolone; Glucocorticoids; Humans; Infusions, Intravenous; Male; Melanoma; Neoplasm Recurrence, Local; Neoplasm Staging; Papilledema; Skin Neoplasms; Uveitis, Anterior; Visual Acuity; Visual Fields

To describe the use of topical difluprednate for the treatment of uveitic macular edema.. Retrospective review of 3 consecutive cases of uveitic macular edema.. Patients were treated with topical difluprednate monotherapy.. All patients experienced complete resolution of uveitic macular edema within 2-4 weeks. We observed a statistically significant improvement in central subfield macular thickness (p = 0.04). There was an overall improvement in visual acuity, but this result was not statistically significant (p = 0.33).. Topical difluprednate can be effective for uveitic macular edema. Further investigation of this therapy in prospective randomized controlled trials is warranted.

Topics: Administration, Topical; Adult; Female; Fluprednisolone; Glucocorticoids; Humans; Macular Edema; Male; Ophthalmic Solutions; Retrospective Studies; Tomography, Optical Coherence; Uveitis, Anterior; Uveitis, Intermediate; Visual Acuity

To present a case of unilateral hypopyon uveitis that began 15 days after uneventful bilateral LASIK in a 24-year-old man with an undisclosed history of ulcerative colitis.. Case report.. The hypopyon uveitis completely resolved after treatment with aggressive topical and oral steroid agents in combination with topical antibiotic coverage.. Although rare, visually significant hypopyon uveitis may arise after LASIK in the setting of ulcerative colitis and positive human leukocyte antigen (HLA) B27. Early recognition and treatment can result in an excellent outcome. The exact relationship between hypopyon uveitis and LASIK is impossible to ascertain.

Topics: Administration, Oral; Administration, Topical; Astigmatism; Colitis, Ulcerative; Fluprednisolone; Glucocorticoids; Granuloma; Humans; Keratomileusis, Laser In Situ; Lasers, Excimer; Male; Myopia; Postoperative Complications; Prednisone; Tomography, Optical Coherence; Uveitis, Anterior; Young Adult

To describe patients with uveitis and common variable immunodeficiency (CVID).. Retrospective observational case series.. Retrospective review of patients with uveitis and CVID, specifically focusing on clinical presentation and treatment.. Three patients with CVID and uveitis were identified. All patients had chronic anterior uveitis. Two required systemic immunosuppression to control uveitis, with one of these patients relapsing after discontinuation of immunoglobulin therapy. One improved on topical steroid therapy; however, follow-up on this patient did not extend beyond 4 months.. CVID can be associated with chronic anterior uveitis. Patients presenting with uveitis should be questioned about frequent infections and autoimmune disorders as part of the uveitis evaluation.

Topics: Adrenal Cortex Hormones; Anti-Inflammatory Agents; Antibodies, Monoclonal; Child; Chronic Disease; Common Variable Immunodeficiency; Female; Fluprednisolone; Glucocorticoids; Humans; Immunoglobulins, Intravenous; Infliximab; Middle Aged; Recurrence; Treatment Outcome; Uveitis, Anterior

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.. A 49-year-old black man presented with a traumatic anterior uveitis recalcitrant to traditional prednisolone acetate 1% treatment. The patient was switched to difluprednate 0.05% in an attempt to better control the ocular inflammation. Although the patient did not exhibit an IOP response after 4 weeks of treatment with prednisolone acetate 1%, he did experience a pressure response within 2 weeks of initiating difluprednate treatment, resulting in an IOP increase from 9 mmHg to 48 mmHg with subsequent microcystic edema. A 44-year-old black woman presented with recurrent scleritis resistant to topical prednisolone acetate, loteprednol etabonate, and oral nonsteroidal anti-inflammatory therapy. Topical loteprednol 0.5% was replaced by difluprednate 0.05%. All evidence of ocular inflammation was eradicated with the changed therapy. IOP rose in the difluprednate-treated eye from 18 mmHg to 34 mmHg over the course of 18 days. In both cases, the IOP elevation was managed rapidly with the discontinuation of difluprednate and temporary use of IOP-reducing agents with no lasting adverse effects.. Difluprednate 0.05% is a new topical therapeutic option indicated for the treatment of inflammation and pain management associated with ocular surgery with an off-label potential for treatment of other anterior segment inflammatory conditions. However, clinicians need to be aware of the potential risk for significant and potentially rapid onset of IOP increase with this medication and manage patients accordingly.

Topics: Administration, Topical; Black or African American; Emulsions; Female; Fluprednisolone; Glucocorticoids; Humans; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Scleritis; Uveitis, Anterior