ESCRS - FPS12.02 - The Intraocular Concentration Of Levofloxacin 1.5% Versus Moxifloxacin 0.5% In Human Aqueous And Vitreous : A Pharmacokinetic Study

The Intraocular Concentration Of Levofloxacin 1.5% Versus Moxifloxacin 0.5% In Human Aqueous And Vitreous : A Pharmacokinetic Study

Published 2022 - 40th Congress of the ESCRS

Reference: FPS12.02 | Type: Free paper | DOI: 10.82333/h8mm-rv70

Authors: Norashikin Maslan 1 , Wan Haslina Halim* 1 , Mae-Lynn Bastion 1 , Mushawiahti Mustapha 1 , Mazlina Mohd Said 2 , Shamin Mohd Saffian 3 , Othmaliza Othman 4 , Mohd Makmor Bakry 3 , Noraida Mohd Shah 3 , Adliah Mhd Ali 3 , Norshamsiah Md Din 4

1Ophthalmology,Hospital Canselor Tunku Mukhriz, Universiti Kebangsaan Malaysia,Cheras,Malaysia, 2Faculty of Pharmacy,Universiti Kebangsaan Malaysia,Kuala Lumpur,Malaysia, 3Centre for Quality Management of Medicines,Faculty of Pharmacy, UKM,Kuala Lumpur,Malaysia, 4Ophthalmology,Hospital Canselor Tunku Mukhriz, Universiti Kebangsaan Malaysia,Kuala Lumpur,Malaysia

Purpose

To compare the pharmacokinetics of topical levofloxacin 1.5% and topical moxifloxacin hydrochloride 0.5% into aqueous and vitreous humor after instillation in human eyes at the different time point post eyedrop instillation

Setting

A prospective, randomised trial of eyes undergoing vitrectomy surgery between September 1, 2019, to December 1, 2021, was conducted at Hospital Canselor Tuanku Mukhriz @ Universiti Kebangsaan Malaysia Medical Centre

Methods

A total of 115 eyes were assigned by stratified sampling into a 1:1 ratio to receive either levofloxacin or moxifloxacin before vitrectomy surgery and into one of four sampling time points, i.e., 1, 2, 4, and 6 hours after their last instilled eye drop. The investigator and laboratory technicians were blinded to the study groups. Three days before vitrectomy surgery, each patient instilled one drop of the assigned study medication into the operative eye four times daily. One aqueous humor and one vitreous specimen were collected from the randomized time points. Samples were assayed for drug concentration using high-performance liquid chromatography.

Results

Concentration of the drugs in the aqueous humour as described by median Cmax and pooled AUC0–6 values were greater for levofloxacin than moxifloxacin (Cmax (IQR): 1170.62ng/mL (486.00,1541.00) and 520.44 ng/mL (382.36,943.87), respectively, P=0.001; AUC0–6 4312.37ng.hr/ml, p<0.001). The pooled AUC0–6 of levofloxacin vitreous humor concentration was greater than moxifloxacin (240.04 ng⋅hr/mL and 174.65ng⋅hr/mL, respectively, p=0.004), but no significant between-treatment difference was observed in mean C max(IQR) values (57.58 (23.28,110.04) ng/mL and 32.95 (18.38,59.82) ng/mL, respectively, p=0.218). No treatment-emergent adverse events were reported.

Conclusions

There was a significantly greater drug concentration following application of topical levofloxacin 1.5% than moxifloxacin 0.5% in the aqueous and vitreous at all time points. The concentration of levofloxacin is similar in both aqueous and vitreous up to 6 hours afterward, showing that levofloxacin1.5% is non-inferior to moxifloxacin 0.5%. Achieving a considerably higher drug concentration in the aqueous humor with levofloxacin 1.5% may demonstrate greater potential for bacterial eradication.