XIBROM SUMMARY
XIBROM (bromfenac ophthalmic solution) 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of Xibrom contains 1.035 mg bromfenac sodium equivalent to 0.9 mg bromfenac free acid.
XIBROM ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
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NEWS HIGHLIGHTS
Published Studies Related to Xibrom (Bromfenac Ophthalmic)
Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. [2011.09]
OBJECTIVE: To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution 0.09% dosed once daily for the treatment of ocular inflammation and pain following cataract extraction with posterior chamber intraocular lens implantation... CONCLUSIONS: Bromfenac ophthalmic solution 0.09% dosed once daily is clinically safe and effective for the treatment of ocular inflammation and the reduction of ocular pain associated with cataract surgery.
PROSPECTIVE RANDOMIZED CONTROLLED TRIAL OF COMBINATION RANIBIZUMAB (LUCENTIS) AND BROMFENAC (XIBROM) FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Pilot Study. [2011.08.20]
PURPOSE:: To evaluate whether bromfenac eyedrops and ranibizumab intravitreal injections would provide added efficacy over ranibizumab alone... CONCLUSION:: This pilot study is the first to prospectively identify a biologic signal that may indicate combination therapy with an easily administered well-tolerated eyedrop and ranibizumab is efficacious for the treatment of neovascular age-related macular degeneration. Further studies are warranted to validate this finding.
Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular
inflammation and pain. [2011]
implantation... CONCLUSIONS: Bromfenac ophthalmic solution 0.09% dosed once daily is clinically
Efficacy of bromfenac sodium ophthalmic solution in preventing cystoid macular oedema after cataract surgery in patients with diabetes. [2010.12]
PURPOSE: To compare the efficacy of bromfenac sodium ophthalmic solution (BF) and a steroidal solution (ST) administered prophylactically against cystoid macular oedema and anterior-chamber inflammation after phacoemulsification and intraocular lens implantation and to assess macular thickness changes using optical coherence tomography (OCT)... CONCLUSION: BF suppressed anterior chamber inflammation and increasing retinal thickening after cataract surgery in patients with NPDR. (c) 2009 The Authors. Journal compilation (c) 2009 Acta Ophthalmol.
Vitreous nonsteroidal antiinflammatory drug concentrations and prostaglandin E2 levels in vitrectomy patients treated with ketorolac 0.4%, bromfenac 0.09%, and nepafenac 0.1%. [2009.10]
PURPOSE: To assess vitreous concentrations of nonsteroidal antiinflammatory drugs (NSAIDs) and prostaglandin E(2) in patients treated with NSAIDs before vitrectomy... CONCLUSION: All three NSAIDs penetrated into the vitreous cavity. Topical therapy with ketorolac may lower preoperative vitreous prostaglandin E(2) levels, which may have a clinical impact on the management of prostaglandin-mediated diseases, including cystoid macular edema.
Clinical Trials Related to Xibrom (Bromfenac Ophthalmic)
Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery [Completed]
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease [Completed]
Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery [Completed]
The primary objective of this study is to investigate the efficacy and safety of bromfenac
ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo
cataract extraction and intraocular lens implantation.
Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser [Recruiting]
This is an investigator-sponsored trial (IST), an open-label pilot study, assessing the
safety and biologic activity of bromfenac in subjects with diffuse DME refractory to laser.
Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1% [Completed]
This is a single-center, randomized, investigator-masked, parallel group, and
active-comparator controlled study investigating the clinical outcomes for visual acuity and
macular thickness after treatment with Bromday (bromfenac ophthalmic solution) 0. 09% QD or
Nevanac (nepafenac ophthalmic suspension) 0. 1% TID in subjects who have undergone cataract
extraction with posterior chamber intraocular lens implantation.
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