Safety and Efficacy of Bromfenac Ophthalmic Solution (Bromday) Dosed Once Daily for Postoperative Ocular Inflammation and Pain

Henderson, Bonnie An; Gayton, Johnny L.; Chandler, Simon; Gow, J.A.; Klier, Sharon; McNamara, T.R.

doi:10.1016/j.ophtha.2011.04.035

Cited by 34 publications

(31 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A sample size of 75 subjects per treatment arm provided 80% power to detect a treatment effect equivalent to that seen with a previous bromfenac formulation 10. This calculation was based on a two-sided Fisher’s exact test of independent proportions conducted with an alpha =0.05 and was performed using PASS (version 2005; NCSS, Kaysville, UT, USA).…”

Section: Methodsmentioning

confidence: 99%

“…Subsequent trials assessing the reduction of anterior chamber inflammation following cataract surgery, with bromfenac 0.09% dosed once daily (which also had a pH of 8.3), found the agent to be effective in the complete clearance of inflammation at all-time points (days 3, 8, and 15) compared with placebo, as well as in reducing ocular inflammation to zero-to-trace levels 10. The US FDA approved bromfenac 0.09% (Bromday ® ; ISTA Pharmaceuticals Inc.) on October 16, 2010; this was the first once-daily ophthalmic NSAID for the treatment of postoperative ocular inflammation and reduction of ocular pain in patients who have undergone cataract extraction with posterior chamber IOL implantation 20.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery

Silverstein¹,

Jackson²,

Goldberg³

et al. 2014

OPTH

View full text Add to dashboard Cite

PurposeTo evaluate the efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace (0–5 cells) anterior chamber cells, following cataract surgery with posterior chamber intraocular lens implantation.MethodsThe study designed employed two Phase III, double-masked, placebo-controlled, multicenter clinical trials of 440 subjects, randomized to either bromfenac ophthalmic solution 0.07% (n=222) or placebo (n=218). Subjects self-dosed once daily, beginning 1 day before undergoing cataract surgery with intraocular lens implantation (day –1) and again on the day of surgery (day 0) and for 14 days postoperatively. Follow-up was on days 1, 3, 8, and 15. The outcome measures included the percentage of subjects with zero-to-trace anterior chamber cells at each visit, as determined by the percentage of subjects with ≤5 anterior chamber cells, overall anterior chamber cell grades, and summed ocular inflammation score (SOIS) (combined anterior chamber cell and flare scores).ResultsThe proportion of subjects with zero-to-trace anterior chamber cells was significantly higher in the bromfenac 0.07% group compared with the placebo group as early as day 3 (P=0.0007), continued at day 8 (P<0.0001), and through day 15 (P<0.0001). At day 15, 80.2% of subjects in the bromfenac 0.07% group achieved zero-to-trace anterior chamber cells compared with 47.2% of subjects who did so in the placebo group. The overall anterior chamber cell scores were significantly lower in the bromfenac 0.07% group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). The SOIS were also significantly lower in the bromfenac group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit).ConclusionBromfenac ophthalmic solution 0.07%, dosed once daily was clinically effective in achieving zero-to-trace anterior chamber cell severity after cataract surgery and was superior to placebo in all anterior chamber cell severity and inflammation outcome measures.

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery

Silverstein¹,

Jackson²,

Goldberg³

et al. 2014

OPTH

View full text Add to dashboard Cite

show abstract

“…Fourteen more papers were further excluded because of lacking parallel placebo control. Finally, the remaining four publications, [22][23][24][25] reporting data from 10 RCTs, met our selection criteria and were included in the pooled-analysis (Supplementary Figure 1).…”

Section: Search Resultsmentioning

confidence: 99%

Topical bromfenac for post-cataract extraction: A systematic review and pooled analysis

Zhai

et al. 2015

Eur J Inflamm

View full text Add to dashboard Cite

Bromfenac, a promising ophthalmic non-steroidal anti-inflammatory drug, has been used once daily for postoperative ocular inflammation and pain with satisfying efficacy, however, no integrated conclusion on its safety in clinical settings has been drawn. The purpose of this pooled analysis is to investigate the safety and efficacy of once daily bromfenac for ocular inflammation and pain among patients after cataract extraction (CE). MEDLINE, PsycINFO, Scopus, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched from inception to September 2014. Randomized controlled trials (RCTs) that studied topical bromfenac after CE were analyzed. Included studies were systemically reviewed, and effects were summarized using odds ratio (OR) with suitable effect model. Four RCTs involving 2294 participants were included. Topical bromfenac significantly increased the proportion of cleared ocular inflammation (OR, 2.37; 95% confidence interval [CI], 1.83-3.07; P <0.00001), ocular pain free (OR, 5.14; 95% CI, 4.07-6.49; P <0.00001), and decreased risk of overall adverse events (OR, 0.47; 95% CI, 0.38-0.58; P <0.00001). Bromfenac has been shown to be a safe and effective treatment for postoperative pain and inflammation in subjects undergoing CE. This is evidenced by the lower incidence of adverse events and the low scores for ocular pain and inflammation across multiple RCTs. However, demographics, co-morbidities of study participants, and the amount of co-medication were not reported, these possible sources of heterogeneity should be examined in future clinical trials.

show abstract

“…Ocular inflammation was determined using the summed ocular inflammation score that evaluates both anterior chamber cells and flare [15,16]. Anterior chamber cells were assessed using a slit lamp biomicroscope at 16× magnification with a 0.3 × 1-mm oblique high-intensity beam.…”

Section: Methodsmentioning

confidence: 99%

Short-Term Outcomes of Coaxial Microincision Cataract Surgery for Uveitis-Associated Cataract without Postoperative Systemic Steroid Therapy

et al. 2013

View full text Add to dashboard Cite

Purpose: To study the necessity of prophylactic systemic steroid therapy after coaxial microincision cataract surgery (MICS) conducted in aged patients during remission of uveitis. Procedures: A total of 17 consecutive patients who underwent MICS were enrolled in this retrospective study. The median age was 73 years. MICS via a 2.2-mm incision was performed. None of the patients received systemic steroid administration after surgery. The visual acuity, intraocular pressure (IOP) and inflammation scores were recorded. Results: The mean logMAR visual acuity was significantly improved from 0.56 ± 0.58 to 0.10 ± 0.30, and the mean inflammation score was reduced from 0.20 to 0.14. Postoperative complications were recurrence of ocular inflammation in 1 eye and elevation of IOP more than 21 mm Hg in 1 eye, which were resolved by topical steroids and topical antiglaucoma medication. Conclusions: Prophylactic systemic steroid therapy after MICS may not be necessary in aged uveitis patients without posterior complications before cataract surgery.

show abstract

Safety and Efficacy of Bromfenac Ophthalmic Solution (Bromday) Dosed Once Daily for Postoperative Ocular Inflammation and Pain

Cited by 34 publications

References 16 publications

The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery

The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery

Topical bromfenac for post-cataract extraction: A systematic review and pooled analysis

Short-Term Outcomes of Coaxial Microincision Cataract Surgery for Uveitis-Associated Cataract without Postoperative Systemic Steroid Therapy

Contact Info

Product

Resources

About