Comparative evaluation of once-daily and twice-daily dosing of topical bromfenac 0.09%: aqueous pharmacokinetics and clinical efficacy study

Abstract

Methods:In phase I, single-drop aqueous pharmacokinetics of topical bromfenac was estimated at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 24 hours using liquid chromatography mass spectrometry in 60 eyes. In phase II, 45 eyes undergoing phacoemulsification were enrolled: group I (control, n = 15), group II (once-daily bromfenac, n = 14), and group III (twice-daily bromfenac, n = 16). Intraoperative pupillary miosis, postoperative anterior chamber (AC) flare, Summed Ocular Inflammation Score (SOIS), central macular thickness (CMT), and pain scores were assessed. Follow-up was performed at 1 day, 7 days, 28 days, and 90 days postoperatively.Results: Half-life of topical bromfenac was 3.6 hours, mean residence time 5.5 hours, and peak concentration (63.73 ng/mL) achieved after 2 hours. Aqueous concentration was more than inhibitory concentration (IC 50 ) at 12 hours but not at 24 hours. Cumulative effect was observed with repeated dosing with aqueous levels more than IC 50 in once-daily and twice-daily groups at 5 days. Significant intraoperative miosis was observed in group I. Pain score, AC flare, and SOIS were significantly more in group I (P < .001) and comparable in groups II and III at all timepoints. CMT was comparable in all groups; no case developed cystoid macular edema.Conclusions: Single-dose topical bromfenac did not maintain therapeutic aqueous concentration over 24 hours; however, cumulative effect was observed with repeated dosing. Clinical efficacy of once-daily and twice-daily dosing was comparable.

Breaking Barriers in Eye Treatment: Polymeric Nano-Based Drug-Delivery System for Anterior Segment Diseases and Glaucoma

“…However, like all surgical procedures, it can carry certain risks and complications, such as corneal edema, cystoid macular edema, endophthalmitis, and retinal detachment. The FDA has approved the use of topical NSAIDs for the prevention of postoperative cystoid macular edema [ 178 ]. However, the use of pharmacological compounds as an alternative to cataract surgery remains under development.…”

Factors influencing aqueous flare after cataract surgery and its evaluation with laser flare photometry

“…97 Twice daily bromfenac 0.09% does not improve postoperative flare compared to once daily dosing. 122 Flare comparisons between topical corticosteroids and NSAIDs have yielded no statistically significant differences between the following: dexamethasone versus flurbiprofen, 101 dexamethasone versus diclofenac, [102][103][104] dexamethasone versus bromfenac 105 ; bromfenac versus betamethasone 108 or bromfenac versus fluorometholone 0.1% 109 ; diclofenac versus 1% prednisolone, 123 fluorometholone/levofloxacin versus tobramycin/dexamethasone. 107 Erichsen et al found no difference in postoperative flare between those taking combination prednisolone 1%/ ketorolac 0.5% versus ketorolac 0.5% alone, 96 as did Ylinen et al with diclofenac 0.1%/dexamethasone 0.1% versus diclofenac 0.1%.…”

Optimization and Characterization of Low-Molecular-Weight Chitosan-Coated Baicalin mPEG-PLGA Nanoparticles for the Treatment of Cataract

“…Liquid eye drops are the most desirable dosage form to treat the local ophthalmic diseases. 6 The quick elimination in the extraocular area leads to the low bioavailability of eye drops which makes frequent instillations an often required method to get the expected therapeutic effect, and this leads to rising inconvenience and adverse effects. 7 The increase in the residence time of the drug in the precorneal area and absorption would improve its therapeutic effect.…”

“…The ocular drug delivery system requires a series of specified characteristics according to the physiological structure of the eye. Liquid eye drops are the most desirable dosage form to treat the local ophthalmic diseases . The quick elimination in the extraocular area leads to the low bioavailability of eye drops which makes frequent instillations an often required method to get the expected therapeutic effect, and this leads to rising inconvenience and adverse effects .…”