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)
Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers [Recruiting]
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in
topical administration of differing dosing regimens of ISV-303 (0. 075% Bromfenac in
DuraSite® ophthalmic solution) compared to vehicle and Xibrom™ when dosed for 2 weeks in
post-cataract-surgery volunteers.
A Dose-Finding Study Comparing InSite Vision, Inc. 101 to Vehicle and DuraSite Alone for Dry Eye Disease [Not yet recruiting]
Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy [Recruiting]
This study will compare the effect of two topical non-steroidal antiinflammatory agents to
control pain after photorefractive keratectomy (PRK) eye surgery.
Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-Operative Cystoid Macular Edema. [Active, not recruiting]
This research is being done to look at the effects of Bromfenac, also called Xibrom for the
treatment of swelling in the retina (the light sensitive tissue in the back of the eye)
called "macular edema" that occurs after cataract surgery. Swelling in the retina can lead
to blurry vision.
The most commonly used treatment is eyedrops that decrease inflammation and may help stop
some of the swelling. We want to see if the drug Bromfenac(Xibrom) can decrease the swelling
in the retina after cataract surgery and improve vision in these patients.
Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care [Recruiting]
To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone
versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual
acuity and OCT measurements.
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