Preclinical Efficacy, Tolerability, and Exploratory Model-Based Pharmacokinetics of a Dual-Drug Biodegradable Intracameral Implant in Rabbits
Abstract
Background: : /Objectives: Postoperative management after cataract surgery involves topical anti-inflammatory and antimicrobial treatments, whose clinical performance may be affected by adherence, administration technique, and intraocular exposure. This study evaluated a biodegradable poly(lactic-co-glycolic acid) intracameral implant containing moxifloxacin hydrochloride and dexamethasone, designed for intraoperative placement.
Methods:: Clinical tolerability, anti-inflammatory activity in a uveitis model, and antibacterial performance following a low-inoculum intravitreal challenge with Pseudomonas aeruginosa were evaluated in New Zealand White rabbits. Aqueous humor pharmacokinetic profiles were also assessed in phakic and aphakic eyes. Clinical follow-up included slit-lamp biomicroscopy and intraocular pressure measurements. Concentration–time data were analyzed by means of nonlinear mixed-effects models and model-based simulations.
Results:: No visible implant material remained four weeks after insertion. A transient pseudo-membrane was observed shortly after implantation in some implanted eyes, but it resolved spontaneously and was not accompanied by clinical inflammatory signs. No sustained increase in intraocular pressure was observed during follow-up. Untreated bacterially challenged eyes rapidly developed severe endophthalmitis, whereas implant-treated eyes showed no clinical evidence of endophthalmitis. In the exploratory uveitis experiment, implant-treated eyes…
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Evidence Hub reads this as a preprint, done in animal, not in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health.
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