Intravitreal injection of polysorbate 80: a functional and morphological study

Area of Science:

• Ophthalmology
• Pharmacology
• Toxicology

Background:

• Polysorbate 80 (PS80) is a common excipient in pharmaceutical formulations.
• Its safety for intravitreal injection, particularly in drug preparations, requires thorough evaluation.
• Understanding PS80's effects on retinal tissue is crucial for developing new ophthalmic treatments.

Purpose of the Study:

• To assess the functional and morphological impact of PS80 on rabbit retinas.
• To determine the safety of PS80 concentrations used in intravitreal drug preparation.

Main Methods:

• Intravitreal injections of PS80 were administered to New Zealand rabbits.
• Control eyes received saline injections.
• Functional assessment included electroretinography (ERG), biomicroscopy, and retinal mapping.
• Morphological analysis was performed using light microscopy post-euthanasia.

Main Results:

• No clinical signs of intraocular inflammation were observed in PS80-injected eyes.
• ERG measurements showed no significant alterations in scotopic or photopic conditions.
• Light microscopy revealed no morphological changes in the retinas.

Conclusions:

• Intravitreal PS80, at concentrations relevant to drug preparation, does not induce functional or morphological retinal damage in rabbits.
• PS80 demonstrates a lack of toxicity to rabbit retinas.
• These findings support the safe use of PS80 in novel lipophilic intravitreal drug formulations.