Global Experience With Xibrom (Bromfenac Ophthalmic Solution) 0.09%: The First Twice-daily Ophthalmic Nonsteroidal Anti-inflammatory Drug

Donnenfeld, Eric D.; Donnenfeld, Ashley

doi:10.1097/01.iio.0000212134.83513.11

Cited by 46 publications

(47 citation statements)

References 16 publications

(14 reference statements)

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“…In contrast, animals in the trough group received intravenous injections of LPS (10 mg/ kg) and FITC-dextran (30 mg/kg) at hour 10, and aqueous humor and ICB samples were collected for analysis at hour 11. 13,14 An additional group of 6 animals received only FITCdextran, and aqueous and ICB samples were collected 1 h later for analysis.…”

Section: Methodsmentioning

confidence: 99%

Ocular Penetration and Anti-inflammatory Activity of Ketorolac 0.45% and Bromfenac 0.09% Against Lipopolysaccharide-Induced Inflammation

Waterbury¹,

Galindo

Villanueva

et al. 2011

Journal of Ocular Pharmacology and Therapeutics

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Purpose: Anti-inflammatory activity of topical nonsteroidal anti-inflammatory drugs is mediated by suppression of cyclooxygenase (COX) isoenzymes. This study compared ocular penetration and inflammation suppression of topical ketorolac 0.45% and bromfenac 0.09% ophthalmic solutions in a rabbit model. Methods: At hour 0, 36 rabbits received ketorolac 0.45%, bromfenac 0.09%, or an artificial tear 3 times once every 20 min. Half of the rabbits in each group then received intravenous injections of lipopolysaccharide (LPS) and fluorescein isothiocyanate (FITC)-dextran at hour 1, and the other half at hour 10. Aqueous and iris-ciliary body (ICB) samples were collected in the former group at hour 2 (peak) and in the latter group at hour 11 (trough) An additional group of 6 animals received only FITC-dextran, and samples were collected 1 h later. Peak and trough nonsteroidal anti-inflammatory drug concentrations were compared with previously determined half-maximal inhibitory concentrations (IC 50 ) for COX isoenzymes. Results: Peak and trough aqueous and ICB concentrations of ketorolac were at least 7-fold or greater than those of bromfenac. At peak levels, both ketorolac 0.45% and bromfenac 0.09% significantly inhibited LPS-induced aqueous prostaglandin E 2 and FITC-dextran elevation (P < 0.01). At trough, both study drugs significantly inhibited LPS-induced aqueous prostaglandin E 2 elevation (P < 0.05), but only ketorolac 0.45% significantly reduced LPS-induced aqueous FITC-dextran elevation (P < 0.01). Aqueous and ICB ketorolac concentrations exceeded its IC 50 for COX-1 and COX-2 at peak and trough. Aqueous and ICB bromfenac levels exceeded its IC 50 for COX-2 at peak and trough, but not for COX-1 at trough aqueous levels and peak and trough ICB levels. Conclusions: Both ketorolac 0.45% and bromfenac 0.09% effectively suppressed inflammation at peak. At trough, only ketorolac 0.45% effectively suppressed inflammation as measured by FITC-dextran leakage. The difference in inflammation suppression may be due to differences in tissue concentrations and/or greater COX-1 suppression by ketorolac 0.45%.

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Section: Methodsmentioning

confidence: 99%

Ocular Penetration and Anti-inflammatory Activity of Ketorolac 0.45% and Bromfenac 0.09% Against Lipopolysaccharide-Induced Inflammation

Waterbury¹,

Galindo

Villanueva

et al. 2011

Journal of Ocular Pharmacology and Therapeutics

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“…However, these studies have invariably shown that the inhibition of PG synthesis with bromfenac -and hence in vitro potency, as measured by its high COX-1/COX-2 IC 50 ratio -was preferentially through COX-2 inhibition, resulting in greater inhibitory effect than most other available NSAIDs; 1,10,15,29 therefore, bromfenac is a unique and highly potent NSAID.…”

Section: Cyclo-oxygenase Inhibitionmentioning

confidence: 99%

“…24,29 These early peak concentrations in aqueous humour remain above the concentration required to inhibit COX-2 by 50%…”

Section: Sustained Therapeutic Activitymentioning

confidence: 99%

“…Iritis (7.0 versus 18.1%; p=0.0001) and eye pain (4.2 versus 11.7%) -among the most common ocular adverse events -were half as frequent with bromfenac as with placebo. 29,34 In separate pooled phase III data from the US and Japan (n=973), bromfenac was generally well tolerated, with only 3.4% of patients experiencing one or more adverse events. 37 It should be noted that more than 20 million patients have been treated with bromfenac worldwide over the past nine years, which…”

Section: Adverse Event Profilementioning

confidence: 99%

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New Look at Ocular Inflammation Control – Powerful and Fast-acting Twice-daily Bromfenac for a Novel Standard in the Treatment of Inflammation

Cho¹,

Mozayan²

2011

European Ophthalmic Review

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Inflammation in the eye arising from various factors -including allergy, infection, injury and surgery -can have serious consequences, and can continue long after the cause is removed, resulting in permanently damaged vision. The treatment of ophthalmic inflammation after surgery has traditionally consisted of topical corticosteroids, but adverse events such as delayed healing, rise in intraocular pressure and increased susceptibility to microbial infections have driven the search for alternative treatments. Non-steroidal anti-inflammatory drugs (NSAIDs) have been used as alternatives to steroid treatments but also have limitations and cause adverse events. Bromfenac has emerged as a potent and safe treatment for inflammation after cataract surgery. Its unique chemical structure makes it a highly lipophilic molecule that penetrates all major ocular tissues in a rapid and sustained manner. It is also a potent inhibitor of the enzyme cyclo-oxygenase-2, which is believed to be the primary mediator of ocular inflammation. These properties permit less frequent dosing (twice-daily [BID]) and greater patient tolerability. A body of efficacy and safety data support use of bromfenac in this indication and it compares favourably with other NSAIDs and steroids in limiting post-operative inflammation. NSAIDs and corticosteroids have different, potentially synergistic effects. However, benefits specific to NSAIDs include lowering prostaglandin E-induced intraocular pressure elevation, no increased risk of secondary infections and stabilisation of the blood-aqueous barrier. With increasing demand for ophthalmic surgery, bromfenac and other treatments are likely to be important components in the treatment of inflammatory conditions after cataract surgery, decreasing pain and contributing to favourable visual outcomes. KeywordsBromfenac, ophthalmic non-steroidal anti-inflammatory drugs, ocular inflammation, cystoid macular oedema, ocular pain Treatments for Ocular InflammationThe two main treatments for ocular inflammation are topical corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs).Corticosteroids interfere with the activity of phospholipase A 2 , thereby inhibiting the release of arachidonic acid metabolites, includingPGs.2 By contrast, NSAIDs non-specifically and irreversibly inhibit the synthesis of PGs by directly interfering with the activity of COX-1 and COX-2 (see Figure 1). 2 CorticosteroidsThe corticosteroids, which are considered the gold standard for the treatment of ocular inflammation, are associated with an increased incidence of adverse events that warrant their judicious use. Most NSAIDs are weakly acidic drugs that ionise at the pH of lacrimal fluid, thus limiting their permeability through the ionic cornea, which has an isoelectric point (pI) of 3.2. 6 Reducing the pH of the formulation increases the un-ionised fraction of the drug, enhancing permeation. Being acidic, NSAIDs are inherently irritant, and reducing the pH of the formulation further increases their irritation potentia...

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“…Only four FDA-approved NSAIDs are used in cataract surgery: diclofenac, ketorolac, nepafenac and bromfenac. Topical NSAIDs are effective in treating inflammation [12,13] and preventing CME [14,15]. …”

Section: Introductionmentioning

confidence: 99%

Bromfenac Sodium 0.1%, Fluorometholone 0.1% and Dexamethasone 0.1% for Control of Ocular Inflammation and Prevention of Cystoid Macular Edema after Phacoemulsification

Wang

Yao²,

Xu³

et al. 2013

Ophthalmologica

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Purpose: To compare bromfenac sodium 0.1%, fluorometholone 0.1% and dexamethasone 0.1% for the control of postoperative inflammation and prevention of cystoid macular edema (CME) after phacoemulsification. Methods: Patients were randomized to receive bromfenac sodium 0.1% for 1 month (OBS1) or 2 months (OBS2), or fluorometholone 0.1% for 1 month (OFM) or dexamethasone 0.1% for 1 month (ODM). Best-corrected visual acuity, intraocular pressure, endothelial cell density, photon count value and retinal foveal thickness were measured. Results: Mean photon count values were lower in the OBS1 and OBS2 groups compared with the ODM group during the first week. Bromfenac sodium cleared the ocular inflammation more rapidly than fluorometholone and dexamethasone. The foveal thickness was thinner in the second month and the incidence of CME was lower in the OBS1 and OBS2 groups compared with the OFM and ODM groups. Conclusion: Bromfenac sodium was more effective and safer than fluorometholone and dexamethasone as an anti-inflammatory, decreasing macular thickness and preventing CME in age-related cataract patients after cataract surgery.

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Global Experience With Xibrom (Bromfenac Ophthalmic Solution) 0.09%: The First Twice-daily Ophthalmic Nonsteroidal Anti-inflammatory Drug

Cited by 46 publications

References 16 publications

Ocular Penetration and Anti-inflammatory Activity of Ketorolac 0.45% and Bromfenac 0.09% Against Lipopolysaccharide-Induced Inflammation

Ocular Penetration and Anti-inflammatory Activity of Ketorolac 0.45% and Bromfenac 0.09% Against Lipopolysaccharide-Induced Inflammation

New Look at Ocular Inflammation Control – Powerful and Fast-acting Twice-daily Bromfenac for a Novel Standard in the Treatment of Inflammation

Bromfenac Sodium 0.1%, Fluorometholone 0.1% and Dexamethasone 0.1% for Control of Ocular Inflammation and Prevention of Cystoid Macular Edema after Phacoemulsification

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