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Drug-Induced Ocular Side Effects: Clinical Ocular Toxicology, 7e Wiley A. 14

Ocular instillation toxicity studies (OITSs) are one of general toxicity studies. Yet, OITSs have a unique characteristic that the test article is directly administered as eye drops to the target organ. Compared with general toxicity studies aiming systemic exposure, the study design of OITSs is somewhat distinctive in selecting test species, dosing formulation, administration volume/frequency and ocular examinations. After the administration of eye drops, the exposure level is high in the ocular surface, whereas the bioavailability in the eye balls, especially in the posterior segment, is low. In contrast to the general toxicity studies aiming systemic exposure, the absolute systemic exposure level in OITSs is generally low, while the systemic bioavailability is relatively high. These pharmacokinetic features determine the profiles of local and systemic toxicities in OITSs. Systemic toxicities are more often found in animals of relatively small body size, and are in most cases related with pharmacological actions. Current progress in ophthalmologic imaging technologies enables advanced safety evaluation using imaging biomarkers. Bioanalysis detecting drug levels present in blood in trace amount leads to a detailed safety assessment of systemic toxicity and yields accurate safety margins. Recognizing the peculiar characteristics of OITSs, toxicologists need to propose an appropriate study design and strategy of safety evaluation. Further discussion may be awaited on rationales for testing both sexes, and for conducting separated toxicity studies to evaluate systemic toxicity. This mini-review provides insight regarding current status and points to consider of OITSs.

Drug-Induced Ocular Side Effects: Clinical Ocular Toxicology, 7e Wiley A. 14


Colour vision deficiencies (CVDs) can be categorised as being congenital or acquired. Some CVDs are already present at birth, as inherited conditions that are the result of changes at the photo-pigment level and are non-pathological, incurable and do not change over time. Examples are red-green defects which are inherited as an X-linked recessive trait. Acquired CVD develops secondary to ocular and systemic conditions or as a side effect of certain medications or sometimes toxic effects of chemicals, and trauma and ageing can also be important in some CVDs.


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