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Michael Bassett, Charles Blizzard, Peter Jarrett, Arthur Driscoll, Ankita Desai, Deepa Mulani, Michael McGrath, Amar Sawhney; Pharmacokinetic Evaluation of Sustained Delivery Moxifloxacin Punctum Plugs. Invest. Ophthalmol. Vis. Sci. 2013;54(15):1097.
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To assess the safety and feasibility of a moxifloxacin-loaded punctum plug (MP) in a post-operative cataract surgery group.
A prospective, single-arm pharmacokinetic study was conducted with 10 patients at the Singapore National Eye Center. The MP was inserted into the punctum of patients following cataract surgery. Study endpoints included ease of insertion, retention and moxifloxacin tear fluid levels at 1h, 24h, and on days 3, 7, 10, 20 and 30. The MP is designed to deliver a bolus followed by extended release encapsulated moxifloxacin; concentrations were targeted to be >250ng/mL through 7 days of treatment.
The average moxifloxacin levels in the tear film by LC-MS/MS ranged from 2,465 to 3,236ng/mL through day 7 as shown in Figure 1. Tear fluid concentrations were below the limit-of-quantification (<LOQ) for days 20 and 30. MP retention was 100% through day 10. Slit lamp examinations most commonly showed aqueous chamber cells and corneal staining/erosion, shown in Table 1. All findings were determined to be related to cataract surgery. Plugs were well tolerated with no adverse events and no ocular complaints or findings other than normal post-cataract symptoms.
The MP delivered and maintained moxifloxacin tear fluid levels above the MIC90s for common susceptible pathogens (250ng/mL) for 7 days in a post-cataract pharmacokinetic study. The MP possessed a favorable safety and tolerability profile over 30 days. Consistent and therapeutic dosing from a punctum plug may be advantageous over patient-administered topical drops to avoid relapse, reduce contagion, and cure the disease.
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