Posters

Good ocular tolerance in rabbits after intracameral administration of Mydrane®, a fixed combination of tropicamide, phenylephrine and lidocaine

Poster Details

First Author: R. Nuijts THE NETHERLANDS

Co Author(s): R. Mencucci   C. Olmiere   A. Behndig              

Abstract Details

Purpose:

This study investigated the safety and tolerability of a single intracameral administration of a combined mydriatic (tropicamide and phenylephrine) and anesthetic (lidocaine) formulation (Mydrane®), given at two different injection volumes with or without rinsing in rabbits.

Setting:

Iris Pharma

Methods:

Sixty (30 male and 30 female) pigmented rabbits in good health and with no signs of ocular irritation were randomly assigned to receive either 100 µL or 200 µL of either Mydrane® or placebo (0.9% NaCl) by intracameral injection. In half of the animals that received Mydrane®, anterior chamber was rinsed with NaCl, 1min after injection. Animals were held in observation for 7 days. From day 1 to day 7 assessments included general clinical and ocular observations, measurements of pupillary diameter, corneal assessments, confocal microscopy, and electroretinography. After euthanasia, eyes were sampled for histology.

Results:

Rapid mydriasis, which was stable at 24 min after injection and had returned to baseline levels by day 1, was induced in all groups that received Mydrane®. There was no effect of rinsing on prolonged stay of Mydrane®. Mydrane® induced no adverse effects on the anterior and posterior segment of the eye (i.e. no increased corneal thickness and endothelial cell loss, no abnormalities in electroretinography) with or without rinsing. Slit lamp examination showed slightly increased anterior chamber inflammation with rinsing in both Mydrane® and placebo groups but not in “without rinsing” groups.

Conclusions:

Mydrane® administered to pigmented rabbits as a single intracameral injection at volumes of 100 µL and 200 µL was very well tolerated with no ocular adverse effects and no effect on the corneal endothelium. No toxic effects of Mydrane® were found with histological evaluation.

Financial Disclosure:

is employed by a forNoneprofit company with an interest in the subject of the presentation, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a competing company