Many eye use products require multiple applications, such as eye drops. Historically, this was done using a rabbit eye test. The need for effective toxicity screening methods that are able to detect the ocular irritation potential of pharmaceutical formulations earlier in their developmental is very important and ultimately reduces costs and helps maintain an adequate level of human eye safety and health. Overall product development cost and human test subject pain and distress can be reduced while promoting robust product safety for public health.
MB Research has developed a novel non-animal method (PorFocal), which utilizes corneas excised from porcine eyes (a normal waste by-product in food production). Utilizing a special long term culture system, porcine corneas can maintained in cultured for several weeks. This allows for multiple dosing (ex. corneas can be dosed 3-4 times per day). Draize rabbit eye testing is insensitive to lower levels of irritation; rendering discrimination between sub-mild irritant product formulations difficult. The only reliable choice for sub-mild irritant testing is human clinical testing. Pre-screening with a in vitro/alternative assay would significantly reduce expensive human testing for products that need to be tested for sub-mild ocular irritation are products that are used daily in the eye area (such as products used in the eye, such as eye drops or cosmetic items). These eye products are often prescribed for daily use for several weeks—for example, a course of ocular antibiotics for conjunctivitis. Human testing using these parameters can become cost prohibitive for manufacturers.