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Evaluation of oculotoxicity of drugs in vitro

Objective

- to create standardised corneal and retinal cell culture procedures to be used in drug toxicity/ safety studies.
-to characterise drug-induced unwanted changes in the cornea and retina at cellular and molecular level in standardised cell cultures.
- to propose an in vitro test battery using standardised eye cell cultures.

This transeuropean research consortium aims to improve the scientific and technical basis for the evaluation of oculotoxicity in vitro and to replace laboratory animal testing by cell culture techniques. Research on various biochemical aspects is applied to cultured corneal (CE) and retinal (RPE) cells. In addition to the conventional cell toxicity testing, tests with novel biochemical and toxicological markers are developed in corneal and retinal cell cultures: e.g. apoptosis, matrix proteins, cell membrane damage, permeability changes, induction of biotransformation enzymes, phagocytic activity of RPE cells, formation of DNA adducts, antioxidative defence systems and retinal neurotoxicity. With these tasks the epithelial integrity of the cornea and the homeostasis of the retina will be evaluated, and the mechanisms of adverse drug reactions (ADRs) of reference compounds and penetration enhancers (PEs) determined. Through participation of pharmaceutical industry in the project, the consortium is privileged to study investigational new drugs (INDs) with systemic, corneal and intravitreal delivery, and to compare them with reference drugs of the same category with clinically documented ocular ADRs. The aim of the proposed project is to develop a standardised in vitro test battery, based on sensitive markers for detection of eye toxicity. The tests are designed for safety evaluation and screening purposes to be used by pharmaceutical industry, by national authorities, and by the EMEA. Four university laboratories from four European countries and two pharmaceutical companies from Europe have established an efficient research network by combining their multidisciplinary expertises, necessary in the development of an in vitro test battery for efficient screening of oculotoxicity.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

University of Tampere
Address
Pobox 607
33101 Tampere
Finland

Participants (5)

Orion Corporation Ltd.
Finland
Address
425,P.o.box
20101 Turku
Oy Star AB
Finland
Address
47,Pansiontie 47
20101 Turku
University of Ioannina
Greece
Address
Dourouti (University Campus)
451 10 Ioannina
Università degli Studi di Pisa
Italy
Address
Via Bonanno Pisano 33
56126 Pisa
Universität Bremen
Germany
Address
Kufsteiner Str. 1
28334 Bremen