The main goal of scientific research in toxicology is to protect humans from the possible adverse effects of contact with various substances. The contact can be accidental or intentional, such as certain drugs. One of the possible effects of exposure and accidental exposure to new live biotherapeutic drugs is eye corrosion/irritation. Therefore, finding an appropriate method to assess the possibility of eye corrosion/irritation is essential to ensure the personal safety of substances for new drug use.
An integral part of the safety assessment of many types of live biotherapeutic products is to assess the potential for eye injury. Eye irritation and corrosion are the most commonly used evaluation indicators. Among them, ocular corrosion refers to eye tissue damage or severe physical deterioration of vision after using the test substance on the anterior surface of the eye, which is not completely reversible within 21 days after use. Ocular irritation refers to the changes in the eye after the test substance is applied to the anterior surface of the eye, which is completely reversible within 21 days after use.
Fig.1 Human eye anatomy.
The Draize rabbit eye test has been used for 60 years to predict the irritation and corrosion of various products to human eyes. However, several aspects of the test have been criticized. These factors include the subjectivity of methods; the overestimation of human response; and the cruelty of methods. In the past 20 years, due to the deficiency of the Draize test, some laboratories have been working on developing alternative in vitro detection methods. Research protocols using different types of cell culture and other methods have been designed to study eye irritation and corrosion.
The ocular surface is a complex system composed of corneal and conjunctival epithelial cells, underlying stroma, and related cells. Its complexity makes it difficult to develop alternative tests with a physiological and mechanical basis that can eliminate animal needs. In addition to Draize rabbit eye test, we have also carried out a lot of research to find a safer test method to replace the eyes of animals. Among them, the application of tissue culture technology, cell, and molecular biology, and cell analysis technology can make us closer to our goal, that is, no animals are needed in eye corrosion and irritation test.
As a leader with extensive experience in live biotherapeutic product development, Creative Biolabs provides animal and non-animal eye irritation/corrosion tests to customers worldwide.
Fig.2 Alternative methods are available to assess ocular corrosion and irritation.
In addition to ocular corrosion/irritation testing, Creative Biolabs continues to provide comprehensive toxicology research services for new live biotherapeutic products research. If you are interested in our services, please contact us for more information.
For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.