Evaluation of a Sustained-Release Prednisolone Acetate Biodegradable Subconjunctival Implant in a Non-Human Primate Model.

ABSTRACT:

Purpose

We evaluate the toxicity and plasma toxicokinetic (TK) profile of a biodegradable subconjunctival microrod for sustained prednisolone acetate (PA) release over 12 weeks in a non-human primate model.

Methods

The biodegradable copolymer poly(l-lactide-co-ε-caprolactone) (PLC) and 40-wt% PA microrods were used and fashioned into 8 and 16 mm lengths. Twelve monkeys were divided into two treatment groups of PA-loaded and blank microrods, with six monkeys each receiving either 8- or 16-mm microrods subconjunctively implanted into both eyes. TK and hematology parameters were analyzed. Ophthalmic clinical evaluation, including slit-lamp and ophthalmoscopy examinations, was performed.

Results

Over the study period of 12 weeks, the mean area under the plasma concentrati

SUBMITTER: Liu YC 

PROVIDER: S-EPMC5629924 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature